Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U10HD021364 | U.S. NIH Grant/Contract | View source | |
| U10HD040689 | U.S. NIH Grant/Contract | View source | |
| U10HD021385 | U.S. NIH Grant/Contract | View source | |
| U10HD027851 | U.S. NIH Grant/Contract | View source | |
| U10HD027853 | U.S. NIH Grant/Contract | View source | |
| U10HD027856 | U.S. NIH Grant/Contract | View source | |
| U10HD027904 | U.S. NIH Grant/Contract | View source | |
| U10HD027880 | U.S. NIH Grant/Contract | View source | |
| U10HD034216 | U.S. NIH Grant/Contract | View source | |
| U10HD021373 | U.S. NIH Grant/Contract | View source | |
| U10HD040492 | U.S. NIH Grant/Contract | View source | |
| U10HD053109 | U.S. NIH Grant/Contract | View source | |
| U10HD053089 | U.S. NIH Grant/Contract | View source | |
| U10HD068244 | U.S. NIH Grant/Contract | View source | |
| U10HD068263 | U.S. NIH Grant/Contract | View source | |
| U10HD068270 | U.S. NIH Grant/Contract | View source | |
| U10HD068278 | U.S. NIH Grant/Contract | View source | |
| U10HD068284 | U.S. NIH Grant/Contract | View source | |
| U10HD036790 | U.S. NIH Grant/Contract | View source |
Not provided
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Study terminated due to safety concerns; participant follow up will continue until March 2018
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
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This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks postmenstrual age (PMA) in premature infants <28 0/7 weeks' gestation.
Approximately 1760 infants are to be enrolled at approximately 18 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) Centers (approximately 44 sites) in the United States. Infants meeting the study selection criteria and for whom informed consent is obtained will be randomized to receive either 80 mg inositol/kg/day or placebo, administered in divided doses every 12 hours (40 mg/kg/dose). Study drug will be administered daily, starting within 12 to 72 hours of birth and continued until the earliest of 34 weeks PMA, 10 weeks chronologic age, or the time of hospital discharge or transfer. Inositol or placebo will be administered IV until enteral feedings reach 120ml/kg/day (or sooner if the infant is no longer receiving IV fluids), at which time the same dose and formulation will be administered enterally every 12 hours.
For publication purposes, the analysis of the primary efficacy outcome will consider the entire study population. In support of a new drug application (NDA) for use of myo-Inositol 5% Injection to increase survival without severe ROP through the determination of acute/final ROP status, the analysis of the primary efficacy outcome will be conducted for the entire study population and separately within pre-specified regulatory sub-studies created by administratively splitting infants enrolled at each study center into two sub-studies.
Assessments performed during the study include customary newborn intensive care procedures including repeat eye examinations until ROP status is final (which often extends after discharge), measurements of growth, cranial ultrasounds or other imaging per usual practice, and the collection of clinical diagnoses throughout hospitalization to evaluate other common morbidities of extreme preterm birth. Adverse events will be recorded from time of treatment initiation until 7 days after the last dose of study drug, and concurrent medications will be recorded from 24 hours prior to randomization until 7 days after the last dose of study drug or until discharge or transfer if sooner. Using the separate NICHD Follow-up protocol, longer term data will be collected at 22-26 months corrected age, including growth, neurodevelopmental testing, overall health status, rehospitalizations, surgeries and diagnoses, including ophthalmic diagnoses and treatments since discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| myo-Inositol 5% Injection | Experimental | Within 12-72 hours of birth, infants will receive 80 mg myo-inositol 5% Injection per kilogram per day, administered in divided doses every 12 hours (40 mg/kg/dose). Study drug will be administered daily and continued until the earliest of 34 completed weeks PMA, 10 weeks (70 days) chronologic age, or the time of discharge. myo-Inositol 5% Injection will be administered IV until enteral feedings are established, at which time the same dose and formulation will be administered enterally every 12 hours. |
|
| 5% glucose(dextrose) | Placebo Comparator | Within 12-72 hours of birth, infants will receive 80 mg 5% glucose(dextrose) USP for intravenous infusion per kilogram per day, administered in divided doses every 12 hours (40 mg/kg/dose). Study drug will be administered daily and continued until the earliest of 34 completed weeks PMA, 10 weeks (70 days) chronologic age, or the time of discharge. myo-Inositol 5% Injection will be administered IV until enteral feedings are established, at which time the same dose and formulation will be administered enterally every 12 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myo-Inositol 5% Injection | Drug | Abbott Nutrition Division, Abbott Laboratories is supplying myo-Inositol 5% Injection to the clinical centers for the duration of the trial. Inositol: myo-Inositol 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. It is administered via IV infusion using syringe pump over 15-30 minutes twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unfavorable Outcome, Defined as Severe Retinopathy of Prematurity (ROP) or Death Prior to Reaching Acute/Final ROP Status | Death is defined as from any cause before Acute/Final ROP status is determined. ROP was identified by routine ophthalmologic examinations beginning at the latter of 31 weeks PMA or 4-6 weeks chronologic age. The favorable ROP endpoint requires that no ROP, or only mild ROP has occurred in both eyes and the eyes have matured beyond the risk of developing Type 1 ROP (severity meeting criteria for surgical intervention). The unfavorable ROP endpoint requires that one or both eyes reach Type 1 ROP. When ROP did not resolve by the time of discharge, participants were followed as outpatients until reaching an ROP endpoint, up to 55 weeks PMA. Since incomplete follow up is more likely among participants with mild or no ROP than for those with aggressive ROP, an independent adjudication process assigned an ROP endpoint of 'most likely never had Type 1 ROP', or 'most likely developed Type 1 ROP' based on clinical and ROP data review to reduce possible missing data bias. | by 55 weeks PMA |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bronchopulmonary Dysplasia (BPD) | BPD is defined as supplemental oxygen required to maintain an oxygenation saturation of >90% at 36 weeks postmenstrual age (PMA) (NICHD physiologic definition). | 36 weeks PMA |
| Number of Participants With Bronchopulmonary Dysplasia (BPD) or Death From BPD |
| Measure | Description | Time Frame |
|---|---|---|
| The Occurrence of Adverse Events and Serious Adverse Events | 7 days post study drug discontinuation | |
| Necrotizing Enterocolitis (NEC) | Stage II or worse, whether treated (medically or surgically) and if the infant survived (modified Bell's classification [Walsh 1986]). |
Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michele C Walsh, MD | Case Western Reserve University, Rainbow Babies and Children's Hospital | Principal Investigator |
| Abhik Das, PhD | RTI International | Principal Investigator |
| Seetha Shankaran, MD | Wayne State University | Principal Investigator |
| Barbara J Stoll, MD | Emory University | Principal Investigator |
| Kurt Schibler, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Greg Sokol, MD | Indiana University | Principal Investigator |
| Abbot R Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island | Principal Investigator |
| Krisa P Van Meurs, MD | Stanford University | Principal Investigator |
| Waldemar A Carlo, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of California - Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34686832 | Derived | Brumbaugh JE, Bell EF, Hirsch SC, Crenshaw EG, DeMauro SB, Adams-Chapman IS, Lowe JR, Natarajan G, Wyckoff MH, Vohr BR, Colaizy TT, Harmon HM, Watterberg KL, Hintz SR; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Relationships between retinopathy of prematurity without ophthalmologic intervention and neurodevelopment and vision at 2 years. Pediatr Res. 2023 Nov;94(5):1720-1730. doi: 10.1038/s41390-021-01778-y. Epub 2021 Oct 22. |
| Label | URL |
|---|---|
| NICHD NRN Website | View source |
Not provided
NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov).
One year after primary publication
NICHD Data and Specimen Repository (DASH)
Not provided
From April 2014 to September 2015, infants born before 28 weeks gestation and surviving >12 hours were screened when admitted to one of the 18 NICHD NRN Centers (approximately 44 sites) in the United States and enrolled in the study if they met the eligibility criteria and consent was obtained before 72 hours postnatal age.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Myo-Inositol 5% Injection | Inositol (i.e myo-Inositol) 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. The medication is administered twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose) begining within 12-72 hours of birth and continuing until the earliest of 34 weeks postmenstrual age (PMA), 10 weeks chronologic age, or the time of discharge. The doses are administered intravenously (IV) using syringe pump over 15-30 minutes until enteral feeds reach 120ml/kg/day (or sooner if the infant is no longer receiving IV fluids), at which time the same dose and formulation will be administered enterally. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
|
| Placebo | Drug | % glucose(dextrose) |
|
BPD is defined as supplemental oxygen required to maintain an oxygenation saturation of >90% at 36 weeks PMA (NICHD physiologic definition). Death from BPD prior to 37 weeks postmenstrual age (PMA) is defined when the cause of death is certified by the Center PI as BPD being the primary cause, or a significant co-contributing cause of death. |
| prior to 37 weeks PMA |
| Number of Participants With All Cause Death Before Retinopathy of Prematurity (ROP) Endpoint | Defined as death from any cause following randomization through primary study follow-up (up to 55 weeks postmenstrual age (PMA)) | by 55 weeks PMA age |
| Number of Participants With Any Retinopathy of Prematurity (ROP) | ROP was identified by routine ophthalmologic examinations beginning at the latter of 31 weeks PMA or 4-6 weeks chronologic age. Any ROP is defined as ROP of any severity that is observed on at least 2 independent examinations in either eye through the time that Acute/Final ROP status is reached (up to 55 weeks postmenstrual age (PMA)). | by 55 weeks PMA |
| Number of Participants With Type 2 or More Severe Retinopathy of Prematurity (ROP) | Defined as one or both eyes reaching Type 2 ROP (ETROP 2003) or the more severe Type 1 ROP (as defined previously) through the time that Acute/Final ROP status is reached (up to 55 weeks postmenstrual age (PMA)). Type 2 ROP is defined as (ETROP 2003): Stage 3 ROP without Plus Disease (i.e. Zone II) or Stage 1 or 2 ROP without Plus Disease (i.e. Zone I). | by 55 weeks PMA |
| Number of Participants With Severe Intraventricular Hemorrhage (IVH) | Severe IVH is defined as IVH Grades 3 or 4 on either side of the brain. The evaluation for IVH occurs early (within 28 days from birth) via a cranial sonogram and is classified as described by Papile. | by 28 days PMA |
| NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
| Isolated Gastrointestinal Perforation | judged not to be due to NEC | NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
| Late Onset Sepsis | culture positive septicemia/bacteremia (≥72 hours of age) treated with antibiotics for ≥ 5 days or died before treatment was completed. | NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
| Patent Ductus Arteriosus (PDA) | Occurrence of clinically significant patent ductus arteriosus (PDA), and if received intervention with prostaglandin inhibitors, and/or surgery. | NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
| Seizures | Seizures treated with an anticonvulsant for >72 hours | NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
| Total Days on Parenteral Nutrition | Total days on parenteral nutrition (including amino acids and/or lipids) | NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
| Days on Oxygen, Days on Ventilator | NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
| Hearing Loss | Hearing loss as defined as never passing a hearing screening in one or both ears | NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
| Neurodevelopment | Neurodevelopment at 22-26 months corrected age (i.e., 22-26 months past due date) using the Bayley Scales of Infant Development III. | 22-26 months corrected age |
| Vision Loss | Vision loss as diagnosed by an ophthalmologist as legally blind, and subdivided into "ophthalmic origin", or "not ophthalmic origin" (i.e., cortical blindness is non-ophthalmic in origin and indicates that there is no retinal detachment or other abnormal fundus or ocular finding, except optic atrophy. Such cases will be considered central [neurologic] in origin.) | 22-26 Months Corrected Age |
| Hearing Loss | Hearing loss requiring that hearing aids be prescribed. | 22-26 Months Corrected Age |
| Cerebral Palsy | Cerebral palsy by severity category (absent/mild/moderate/severe). | 22-26 Months Corrected Age |
| Overall Health Status | Overall health status per recall from the parent/guardian (including survival, re-hospitalizations, surgeries, ongoing medications, and chronic illnesses). | 22-26 Months Corrected Age |
| Kathleen A Kennedy, MD, MPH |
| The University of Texas Health Science Center, Houston |
| Principal Investigator |
| Ronald N Goldberg, MD | Duke University | Principal Investigator |
| Edward F Bell, MD | University of Iowa | Principal Investigator |
| Dale L Phelps, MD | University of Rochester | Study Director |
| Carl T D'Angio, MD | University of Rochester | Principal Investigator |
| William Truog, MD | Children's Mercy Hospital Kansas City | Principal Investigator |
| Pablo Sanchez, MD | Research Institute at Nationwide Children's Hospital | Principal Investigator |
| Uday Devaskar, MD | University of California, Los Angeles | Principal Investigator |
| Myra Wyckoff, MD | University of Texas at Southwestern | Principal Investigator |
| Kristi L Watterberg, MD | University of New Mexico | Principal Investigator |
| Barbara Schmidt, MD | University of Pennsylvania | Principal Investigator |
| Los Angeles |
| California |
| 90025 |
| United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| RTI International | Durham | North Carolina | 27705 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Univeristy of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| NICHD Pregnancy \& Perinatology Branch | View source |
| FG001 | 5% Glucose(Dextrose) | The placebo is 5% dextrose (5% glucose) in sterile water (D5W pyrogen and preservative free) United States Pharmacopoeia (USP) for IV infusion. The placebo is administered in the same dose (80 mg glucose/kg/day divided in 2 doses administered every 12 hours) and dispensed in the same manner (intravenously or enterally) as the inositol. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Myo-Inositol 5% Injection | Inositol (i.e myo-Inositol) 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. The medication is administered twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose) begining within 12-72 hours of birth and continuing until the earliest of 34 weeks postmenstrual age (PMA), 10 weeks chronologic age, or the time of discharge. The doses are administered intravenously (IV) using syringe pump over 15-30 minutes until enteral feeds reach 120ml/kg/day (or sooner if the infant is no longer receiving IV fluids), at which time the same dose and formulation will be administered enterally. |
| BG001 | 5% Glucose(Dextrose) | The placebo is 5% dextrose (5% glucose) in sterile water (D5W pyrogen and preservative free) United States Pharmacopoeia (USP) for IV infusion. The placebo is administered in the same dose (80 mg glucose/kg/day divided in 2 doses administered every 12 hours) and dispensed in the same manner (intravenously or enterally) as the inositol. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | weeks |
| |||||||||||||||
| Age, Continuous | Median | Full Range | weeks |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Age, Customized | Age at start of study therapy is only available for infants who started treatment (313 Inositol and 319 Placebo). | Mean | Standard Deviation | Days |
| ||||||||||||||
| Age, Customized | Age at start of study therapy is only available for infants who started treatment (313 Inositol and 319 Placebo). | Median | Full Range | Days |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| BIRTH WEIGHT | Mean | Standard Deviation | Grams |
| |||||||||||||||
| BIRTH WEIGHT | Median | Full Range | Grams |
| |||||||||||||||
| ANTENATAL STEROIDS | Count of Participants | Participants |
| ||||||||||||||||
| EARLY ONSET SEPSIS | Count of Participants | Participants |
| ||||||||||||||||
| APGAR-5 MINUTE | Count of Participants | Participants |
| ||||||||||||||||
| APGAR-5 MINUTE | 10-point, ordinal scale specifying infant's overall health 5 minutes after birth from 1 (needs immediate medical help) to 10 (in optimal health). | Median | Full Range | Units on a Scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Unfavorable Outcome, Defined as Severe Retinopathy of Prematurity (ROP) or Death Prior to Reaching Acute/Final ROP Status | Death is defined as from any cause before Acute/Final ROP status is determined. ROP was identified by routine ophthalmologic examinations beginning at the latter of 31 weeks PMA or 4-6 weeks chronologic age. The favorable ROP endpoint requires that no ROP, or only mild ROP has occurred in both eyes and the eyes have matured beyond the risk of developing Type 1 ROP (severity meeting criteria for surgical intervention). The unfavorable ROP endpoint requires that one or both eyes reach Type 1 ROP. When ROP did not resolve by the time of discharge, participants were followed as outpatients until reaching an ROP endpoint, up to 55 weeks PMA. Since incomplete follow up is more likely among participants with mild or no ROP than for those with aggressive ROP, an independent adjudication process assigned an ROP endpoint of 'most likely never had Type 1 ROP', or 'most likely developed Type 1 ROP' based on clinical and ROP data review to reduce possible missing data bias. | The analysis was performed on an intention to treat basis, including adjudicated ROP endpoints. Individuals for whom adjudicated ROP endpoints could not be obtained were treated as missing completely at random, and excluded from the primary analyses (4 Inositol and 1 Placebo). | Posted | Count of Participants | Participants | by 55 weeks PMA |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Bronchopulmonary Dysplasia (BPD) | BPD is defined as supplemental oxygen required to maintain an oxygenation saturation of >90% at 36 weeks postmenstrual age (PMA) (NICHD physiologic definition). | The analysis was performed on an intention to treat basis. Individuals for whom BPD outcome could not be obtained were treated as missing completely at random, and excluded from the analyses (45 Inositol and 33 Placebo). | Posted | Count of Participants | Participants | 36 weeks PMA |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Bronchopulmonary Dysplasia (BPD) or Death From BPD | BPD is defined as supplemental oxygen required to maintain an oxygenation saturation of >90% at 36 weeks PMA (NICHD physiologic definition). Death from BPD prior to 37 weeks postmenstrual age (PMA) is defined when the cause of death is certified by the Center PI as BPD being the primary cause, or a significant co-contributing cause of death. | The analysis was performed on an intention to treat basis. Individuals who died prior to 37 weeks PMA for whom the cause(s) of death are unknown or individuals for whom BPD outcome could not be obtained were treated as missing completely at random, and excluded from the analyses (1 Inositol and 5 Placebo). | Posted | Count of Participants | Participants | prior to 37 weeks PMA |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Cause Death Before Retinopathy of Prematurity (ROP) Endpoint | Defined as death from any cause following randomization through primary study follow-up (up to 55 weeks postmenstrual age (PMA)) | The analysis was performed on an intention to treat basis. | Posted | Count of Participants | Participants | by 55 weeks PMA age |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Retinopathy of Prematurity (ROP) | ROP was identified by routine ophthalmologic examinations beginning at the latter of 31 weeks PMA or 4-6 weeks chronologic age. Any ROP is defined as ROP of any severity that is observed on at least 2 independent examinations in either eye through the time that Acute/Final ROP status is reached (up to 55 weeks postmenstrual age (PMA)). | The analysis was performed on an intention to treat basis. Individuals for whom ROP status could not be defined were treated as missing completely at random, and excluded from the analyses (50 Inositol and 35 Placebo). | Posted | Count of Participants | Participants | by 55 weeks PMA |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Type 2 or More Severe Retinopathy of Prematurity (ROP) | Defined as one or both eyes reaching Type 2 ROP (ETROP 2003) or the more severe Type 1 ROP (as defined previously) through the time that Acute/Final ROP status is reached (up to 55 weeks postmenstrual age (PMA)). Type 2 ROP is defined as (ETROP 2003): Stage 3 ROP without Plus Disease (i.e. Zone II) or Stage 1 or 2 ROP without Plus Disease (i.e. Zone I). | The analysis was performed on an intention to treat basis. Individuals for whom ROP status and/or type could not be defined were treated as missing completely at random, and excluded from the analyses (54 Inositol and 36 Placebo). | Posted | Count of Participants | Participants | by 55 weeks PMA |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Severe Intraventricular Hemorrhage (IVH) | Severe IVH is defined as IVH Grades 3 or 4 on either side of the brain. The evaluation for IVH occurs early (within 28 days from birth) via a cranial sonogram and is classified as described by Papile. | The analysis was performed on an intention to treat basis. Individuals for whom severe IVH status could not be defined were treated as missing completely at random, and excluded from the analyses (6 Inositol and 4 Placebo). | Posted | Count of Participants | Participants | by 28 days PMA |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | The Occurrence of Adverse Events and Serious Adverse Events | Not Posted | 7 days post study drug discontinuation | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Necrotizing Enterocolitis (NEC) | Stage II or worse, whether treated (medically or surgically) and if the infant survived (modified Bell's classification [Walsh 1986]). | Not Posted | NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Isolated Gastrointestinal Perforation | judged not to be due to NEC | Not Posted | NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Late Onset Sepsis | culture positive septicemia/bacteremia (≥72 hours of age) treated with antibiotics for ≥ 5 days or died before treatment was completed. | Not Posted | NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Patent Ductus Arteriosus (PDA) | Occurrence of clinically significant patent ductus arteriosus (PDA), and if received intervention with prostaglandin inhibitors, and/or surgery. | Not Posted | NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Seizures | Seizures treated with an anticonvulsant for >72 hours | Not Posted | NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Total Days on Parenteral Nutrition | Total days on parenteral nutrition (including amino acids and/or lipids) | Not Posted | NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Days on Oxygen, Days on Ventilator | Not Posted | NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Hearing Loss | Hearing loss as defined as never passing a hearing screening in one or both ears | Not Posted | NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Neurodevelopment | Neurodevelopment at 22-26 months corrected age (i.e., 22-26 months past due date) using the Bayley Scales of Infant Development III. | Not Posted | 22-26 months corrected age | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Vision Loss | Vision loss as diagnosed by an ophthalmologist as legally blind, and subdivided into "ophthalmic origin", or "not ophthalmic origin" (i.e., cortical blindness is non-ophthalmic in origin and indicates that there is no retinal detachment or other abnormal fundus or ocular finding, except optic atrophy. Such cases will be considered central [neurologic] in origin.) | Not Posted | 22-26 Months Corrected Age | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Hearing Loss | Hearing loss requiring that hearing aids be prescribed. | Not Posted | 22-26 Months Corrected Age | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cerebral Palsy | Cerebral palsy by severity category (absent/mild/moderate/severe). | Not Posted | 22-26 Months Corrected Age | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Overall Health Status | Overall health status per recall from the parent/guardian (including survival, re-hospitalizations, surgeries, ongoing medications, and chronic illnesses). | Not Posted | 22-26 Months Corrected Age | Participants |
Adverse events will be recorded from treatment initiation until 7 days after the last dose of study drug, up to the earliest of 34 weeks post-menstrual age (PMA), 10 weeks chronologic age (CA), or discharge.
The at-risk population for all-cause mortality is the intent-to-treat (ITT) population which consists of all randomized participants (317 Inositol 321 Placebo). The at-risk population for serious adverse events and/or other (not including serious) adverse events is the safety-population which consists of all individuals who started treatment (313 Inositol 319 Placebo).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Myo-Inositol 5% Injection | Inositol (i.e myo-Inositol) 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. The medication is administered twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose) begining within 12-72 hours of birth and continuing until the earliest of 34 weeks postmenstrual age (PMA), 10 weeks chronologic age, or the time of discharge. The doses are administered intravenously (IV) using syringe pump over 15-30 minutes until enteral feeds reach 120ml/kg/day (or sooner if the infant is no longer receiving IV fluids), at which time the same dose and formulation will be administered enterally. | 50 | 317 | 113 | 313 | 291 | 313 |
| EG001 | 5% Glucose(Dextrose) | The placebo is 5% dextrose (5% glucose) in sterile water (D5W pyrogen and preservative free) United States Pharmacopoeia (USP) for IV infusion. The placebo is administered in the same dose (80 mg glucose/kg/day divided in 2 doses administered every 12 hours) and dispensed in the same manner (intravenously or enterally) as the inositol. | 33 | 321 | 105 | 319 | 298 | 319 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PULMONARY AIR LEAK | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY HEMORRHAGE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY DETERIORATION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| CHOLESTASIS | Gastrointestinal disorders | Systematic Assessment |
| ||
| DELAYED GASTRIC EMPTYING | Gastrointestinal disorders | Systematic Assessment |
| ||
| ELEVATED LIVER ENZYMES | Gastrointestinal disorders | Systematic Assessment |
| ||
| EMESIS | Gastrointestinal disorders | Systematic Assessment |
| ||
| NEC | Gastrointestinal disorders | Systematic Assessment |
| ||
| SPONTANEOUS INTESTINAL PERFORATION, WITHOUT NEC | Gastrointestinal disorders | Systematic Assessment |
| ||
| SUPERFICIAL INFECTION | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| SYSTEMIC INFECTION | Infections and infestations | Systematic Assessment |
| ||
| IVH | Nervous system disorders | Systematic Assessment |
| ||
| SEIZURES | Nervous system disorders | Systematic Assessment |
| ||
| BRADYCARDIA | Cardiac disorders | Systematic Assessment |
| ||
| CONGESTIVE HEART FAILURE | Cardiac disorders | Systematic Assessment |
| ||
| HYPERTENSION | Cardiac disorders | Systematic Assessment |
| ||
| PDA | Cardiac disorders | Systematic Assessment |
| ||
| POOR PERFUSION OR HYPOTENSION | Cardiac disorders | Systematic Assessment |
| ||
| ANEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| HYPERBILIRUBINEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| NEUTROPENIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| THROMBOCYTOSIS | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| DIURESIS | Renal and urinary disorders | Systematic Assessment |
| ||
| ELEVATED CREATININE | Renal and urinary disorders | Systematic Assessment |
| ||
| HYPERKALEMIA | Renal and urinary disorders | Systematic Assessment |
| ||
| HEMATURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| OLIGURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| PROTEINURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| HYPERGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPOGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| SKIN BREAKDOWN | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| HYPOXIC RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| CARDIOPULMONARY ARREST | Cardiac disorders | Systematic Assessment |
| ||
| SKIN CELLULITIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| PULMONARY VALVE STENOSIS | Cardiac disorders | Systematic Assessment |
| ||
| ADRENAL INSUFFICENCY | Endocrine disorders | Systematic Assessment |
| ||
| COAGULOPATHY | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| ESPHOGEAL PERFORATION | Gastrointestinal disorders | Systematic Assessment |
| ||
| ILEUS | Gastrointestinal disorders | Systematic Assessment |
| ||
| LEUKOCYTOSIS | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| HEPATIC FAILURE | Hepatobiliary disorders | Systematic Assessment |
| ||
| ACIDOSIS | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPERCALCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPONATREMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPERNATREMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| RENAL FAILURE | Renal and urinary disorders | Systematic Assessment |
| ||
| COMPARTMENT SYNDROME | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| MECONIUM PLUG SYNDROME | Gastrointestinal disorders | Systematic Assessment |
| ||
| THROMBOSIS | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| HYPERBILIRUBINEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| NEUTROPENIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| THROMBOCYTOSIS | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| DIURESIS | Renal and urinary disorders | Systematic Assessment |
| ||
| ELEVATED CREATININE | Renal and urinary disorders | Systematic Assessment |
| ||
| HYPERKALEMIA | Renal and urinary disorders | Systematic Assessment |
| ||
| GLUCOSUIRA | Renal and urinary disorders | Systematic Assessment |
| ||
| HEMATURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| OLIGURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| PROTEINURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| PULMONARY AIR LEAK | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY HEMORRHAGE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY DETERIORATION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| CONGESTIVE HEART FAILURE | Cardiac disorders | Systematic Assessment |
| ||
| HYPERTENSION | Cardiac disorders | Systematic Assessment |
| ||
| PDA | Cardiac disorders | Systematic Assessment |
| ||
| POOR PERFUSION OR HYPOTENSION | Cardiac disorders | Systematic Assessment |
| ||
| TACHYCARDIA | Cardiac disorders | Systematic Assessment |
| ||
| CHOLEOSTASIS | Gastrointestinal disorders | Systematic Assessment |
| ||
| DELAYED GASTRIC EMPTYING | Gastrointestinal disorders | Systematic Assessment |
| ||
| DIARRHEA | Gastrointestinal disorders | Systematic Assessment |
| ||
| ELEVATED LIVER ENZYMERS | Gastrointestinal disorders | Systematic Assessment |
| ||
| EMESIS | Gastrointestinal disorders | Systematic Assessment |
| ||
| NEC | Gastrointestinal disorders | Systematic Assessment |
| ||
| SPONTANEOUS INTESTINAL PERFORATION WITHOUT NEC | Gastrointestinal disorders | Systematic Assessment |
| ||
| HYPERGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPOGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| LOCAL INFECTION | Infections and infestations | Systematic Assessment |
| ||
| SUPERFICIAL INFECTION | Infections and infestations | Systematic Assessment |
| ||
| SYSTEMIC INFECTION | Infections and infestations | Systematic Assessment |
| ||
| ABNORMAL MOVEMENTS | Nervous system disorders | Systematic Assessment |
| ||
| IVH | Nervous system disorders | Systematic Assessment |
| ||
| SEIZURES | Nervous system disorders | Systematic Assessment |
| ||
| STATE OF ALERTNESS | Nervous system disorders | Systematic Assessment |
| ||
| RASH | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| SKIN BREAKDOWN | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| HYPOTHERMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| OTHER | Blood and lymphatic system disorders | Systematic Assessment | Other (not including serious) adverse events under blood and lymphatic system disorders includes frank blood drainage from Penrose drain. |
| |
| OTHER | Cardiac disorders | Systematic Assessment | Other (not including serious) adverse events under cardiac disorders include atrial vegetation/thrombus, femoral continuous loop complication (under perfusion right leg and great toe) |
| |
| RENAL DYSFUNCTION | Renal and urinary disorders | Systematic Assessment |
| ||
| RENAL FAILURE | Renal and urinary disorders | Systematic Assessment |
| ||
| BILATERAL HYDRONEPHROSIS | Renal and urinary disorders | Systematic Assessment |
| ||
| CHRONIC LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| ABDOMINAL DISTENTION | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| BLOODY STOOL | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| BOWEL DYSFUNCTION | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| ESOPHOGEAL PERFORATION | Gastrointestinal disorders | Systematic Assessment |
| ||
| FEEDING INTOLERANCE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| GASTRITIS | Gastrointestinal disorders | Systematic Assessment |
| ||
| GASTROINTESTINAL FISTULA | Gastrointestinal disorders | Systematic Assessment |
| ||
| ILEUS | Gastrointestinal disorders | Systematic Assessment |
| ||
| STRICTURES REQUIRING SURGERY | Gastrointestinal disorders | Systematic Assessment |
| ||
| ACIDOSIS | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| FAILURE TO THRIVE | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| HYPERTHYROIDISM | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPOTHYROIDISM | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| ELEVATED 17-OH PROGESTERONE | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| RICKETS | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPOCALCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPOPHOSPHATEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPONATREMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPERNATREMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPERTRIGLYCERIDEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| IV INFILTRATE | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| SKIN LESION | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| ADRENAL INSUFFICIENCY | Endocrine disorders | Systematic Assessment |
| ||
| INTRACRANIAL HEMORRHAGE | Nervous system disorders | Systematic Assessment |
| ||
| OSTEOPENIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| ATOPIC DERMATITIS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| SOFT TISSUE NECROSIS (UPPER LIMB) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| THROMBOSIS | Vascular disorders | Systematic Assessment |
| ||
| GRANULATION TISSUE PROLAPSE (PENROSE DRAIN SITE) | Gastrointestinal disorders | Systematic Assessment |
| ||
| NASAL SEPTIC BREAKDOWN | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| URINARY TRACT INFECTION | Infections and infestations | Systematic Assessment |
|
Due to a manufacturing issue, enrollment and treatment were temporarily suspended pending review of primary outcome data for the enrolled infants. The statistically significant increase in mortality resulted in early study termination.
Investigators must adhere to the Neonatal Research Network Publication policies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dale Phelps | University of Rochester | (585) 275-2972 | dale_phelps@urmc.rochester.edu |
| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| D012164 | Retinal Diseases |
| D047928 | Premature Birth |
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007294 | Inositol |
| D007267 | Injections |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
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| OG001 |
| 5% Glucose(Dextrose) |
The placebo is 5% dextrose (5% glucose) in sterile water (D5W pyrogen and preservative free) United States Pharmacopoeia (USP) for IV infusion. The placebo is administered in the same dose (80 mg glucose/kg/day divided in 2 doses administered every 12 hours) and dispensed in the same manner (intravenously or enterally) as the inositol. |
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The placebo is 5% dextrose (5% glucose) in sterile water (D5W pyrogen and preservative free) United States Pharmacopoeia (USP) for IV infusion. The placebo is administered in the same dose (80 mg glucose/kg/day divided in 2 doses administered every 12 hours) and dispensed in the same manner (intravenously or enterally) as the inositol. |
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| 5% Glucose(Dextrose) |
The placebo is 5% dextrose (5% glucose) in sterile water (D5W pyrogen and preservative free) United States Pharmacopoeia (USP) for IV infusion. The placebo is administered in the same dose (80 mg glucose/kg/day divided in 2 doses administered every 12 hours) and dispensed in the same manner (intravenously or enterally) as the inositol. |
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