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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo
Advances in neonatal care have led to significant improvements in the survival of the nearly 60,000 very low birth weight (VLBW) infants born each year in the U.S. Improving neurodevelopmental outcomes for these preterm infants continues to be a major goal for neonatal care providers. A subset of these infants sustain a grade 3 or 4 intraventricular hemorrhage (IVH) resulting in an increase in the incidence of developmental delay. Moreover, almost one third of preterm infants with normal head ultrasounds also develop cognitive delay. Although a variety of neuroprotective treatment strategies have been evaluated, no specific treatment has been identified to reduce or prevent brain injury in these most vulnerable preterm infants.
A potential neuroprotective therapy involves administering erythropoiesis stimulating agents (ESAs) such as erythropoietin (Epo) and Darbepoetin (Darbe, a longer acting ESA). In addition to stimulating erythropoiesis, ESAs have been shown to be protective in the developing brain in animal models, making it possibly beneficial for very premature infants who are at risk for intraventricular hemorrhage, hypoxic-ischemic injury, and developmental delay. The neuroprotective mechanisms of ESAs include increased neurogenesis, decreased neuronal susceptibility to glutamate toxicity, decreased neuronal apoptosis, decreased inflammation, decreased nitric oxide-mediated injury, increased antioxidant response, decreased axonal degeneration, and increased protective effects on glia. This is a randomized, masked, placebo controlled clinical study in which enrolled infants will receive weekly Darbe or placebo (sham) dosing.
Extended follow-up: Subjects will be seen for follow-up at 4-5 years (i.e., 4 years - 4 years 11 months) corrected age and 6-7 years (i.e., 6 years - 6 years 11 months) corrected age to characterize the functional, behavioral and neurological outcomes of the extremely low birth weight (ELBW) population at school age based on treatment with darbepoetin versus placebo in the neonatal period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darbepoetin | Experimental | Darbepoetin 10 micrograms/kg/once every week (IV or SC) |
|
| Placebo | Placebo Comparator | Equal volume normal saline for IV administration, or sham dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darbepoetin | Drug | Darbepoetin 10 micrograms/kg/once every week (IV or SC). Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Bayley III Composite Cognitive Score | Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score, where subjects who died prior to the follow-up assessment are assigned the lowest possible score of 54. This is a standardized scale where a score that is more than 1 normative standard deviation from the normative mean of 100 signifies mild developmental delay (score < 85); 2 standard deviations below the mean, moderate delay (score < 70); and 3 standard deviations below the mean, severe delay (score < 55). This self-standing scale comprises the primary outcome for the Darbe study. | 22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlier |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Transfusions Per Infant | The number of transfusions recorded during the study, up to 35 completed weeks gestational age | Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks) |
| Total Volume of Transfusions Per Infant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Ohls, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41392547 | Derived | Maxwell JR, Ohls RK, An G, Winter D, Beauman S, Buhrman J, Jantzie LL. Development of an electrochemiluminescence assay to measure serum darbepoetin concentration in extremely preterm infants. Bioanalysis. 2025 Dec;17(23):1553-1559. doi: 10.1080/17576180.2025.2600914. Epub 2025 Dec 14. | |
| 40354084 | Derived | Ohls RK, Das A, Tan S, Lowe JR, Schibler K, Beauman SS, Bell EF, Laptook AR, Baserga M, Patel RM, Carlton DP, Flibotte J, Grisby C, Higgins RD, Shankaran S, Watterberg K, Hibbs AM, Carlo WA, Colaizy TT, Van Meurs KP, Kicklighter SD, Moore R, Sollinger C, Chalak LF, Ghavam S, Poindexter BB, Tyson JE, Cotten CM, Baack ML, Fathi O, DeMauro SB, Laughon MM, Reynolds AM, Duncan AF, Winter S, Wilson-Costello DE, Peralta-Carcelen M, Vohr BR, Harmon HM, Hintz SR, Cavanaugh B, Heyne RJ, Merhar S, Mosquera R, Sewell E, Malcolm WF, Richards LA, Benninger KL, Trembath A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Darbepoetin, Red Cell Mass, and Neuroprotection in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2025 Aug 1;179(8):836-845. doi: 10.1001/jamapediatrics.2025.0807. |
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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) or NHLBI BIOLINCC (https://biolincc.nhlbi.nih.gov/home/).
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| ID | Title | Description |
|---|---|---|
| FG000 | Darbepoetin | Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks' PMA, intravenously when the infant had intravenous access, otherwise subcutaneously |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2019 | Jun 14, 2024 |
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Randomized, masked, placebo-controlled trial
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Primary providers and bedside caregivers will be blinded to randomization group. If the dose will be administered IV, the study drug will be administered slow IV push by the bedside nurse. If the dose will be administered subcutaneously, the study drug will be brought to the bedside in a closed container, and injections will be shielded behind screens and out of earshot from caregivers and parents. An adhesive bandage (or 2x2 gauze) will be placed over the true and sham injection sites and either taped or held in place until no evidence of the injection is visible. The parents, medical providers, data collection staff and neurodevelopmental follow up personnel will be masked to the treatment arm.
|
| Placebo | Drug | normal saline for IV administration, or sham dosing. Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital. |
|
|
The total volume of transfusions for the infant if ever transfused |
| Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks) |
| Number of Donor Exposures Per Infant | The number of donor exposures recorded during the study, up to 35 completed weeks gestational age | Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks) |
| Hematocrit | Hematocrit adjusted for center, gestational age group, and familial clustering | at 2 and at 7 weeks in the study |
| Red Cell Mass | Red Cell Mass (Circulating Erythrocyte Volume), adjusted for center, gestational age group, and familial clustering | at 2 and at 7 weeks in the study |
| Necrotizing Enterocolitis, Bells Stage >=2 With Surgery | This is measured as Yes if experienced necrotizing enterocolitis, Bells stage >=2 with surgery; Otherwise, No. | Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days) |
| Bronchopulmonary Dysplasia Grades 2 or 3 | This is measured as Yes if infant is on invasive mechanical ventilation, nasal cannula >2 L/min or noninvasive positive airway pressure at 36 weeks of postmenstrual age; Otherwise, No. | At 36 weeks postmenstrual age |
| Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received | This is measured as Yes if experienced Retinopathy of prematurity stage >=3 or treatment for that condition received; Otherwise, No. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease. | Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days) |
| Intraventricular Hemorrhage Grade I+ | This is measured as Yes if experienced Grade I+ Intraventricular Hemorrhage; Otherwise, No. | Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days) |
| Length of Hospital Stay | This is measured as the length of stay up to hospital discharge or death, whichever occurred first. | At initial hospital discharge or at death if it occurs earlier (a median of 94 days), assessed up to one year of life. |
| Death | This is measured as Yes if an infant died between birth and 22-26 months corrected age; Otherwise, No. | Birth, through the 22-26 months corrected age follow-up window, which corresponds to a median of 29 months calendar age in the analysis population |
| Neurodevelopmental Impairment | This is a 4-level outcome, where Severe NDI denotes a BSID III cognitive score less than 70, a Gross Motor Functional (GMF) level of 3-5 (where higher scores indicate worse outcomes), blindness (less than 20/200 vision), and/or profound hearing loss, Moderate NDI denotes a BSID III cognitive score from 70-84 and either a GMF level of 2 or limited blindness / moderate hearing loss, Mild NDI denotes a BSID III cognitive score from 70-84, or a cognitive score >=85 with a GMF level of 1 and/or mild hearing loss, and No NDI denotes a cognitive score >= 85 and an absence of neurosensory deficits. | At 22-26 months corrected age (a median of 25 months corrected age) |
| Any Cerebral Palsy | This is measured as Yes if the child has been deemed by the medical examiner as having Cerebral Palsy; Otherwise, No. | At 22-26 months corrected age (a median of 25 months corrected age) |
| Palo Alto |
| California |
| 94304 |
| United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | 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 and 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 |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| 37596391 | Derived | Bahr TM, Tan S, Smith E, Beauman SS, Schibler KR, Grisby CA, Lowe JR, Bell EF, Laptook AR, Shankaran S, Carlton DP, Rau C, Baserga MC, Flibotte J, Zaterka-Baxter K, Walsh MC, Das A, Christensen RD, Ohls RK; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Serum ferritin values in neonates <29 weeks' gestation are highly variable and do not correlate with reticulocyte hemoglobin content. J Perinatol. 2023 Nov;43(11):1368-1373. doi: 10.1038/s41372-023-01751-z. Epub 2023 Aug 18. |
| 33432157 | Derived | Vu PT, Ohls RK, Mayock DE, German KR, Comstock BA, Heagerty PJ, Juul SE; PENUT Consortium. Transfusions and neurodevelopmental outcomes in extremely low gestation neonates enrolled in the PENUT Trial: a randomized clinical trial. Pediatr Res. 2021 Jul;90(1):109-116. doi: 10.1038/s41390-020-01273-w. Epub 2021 Jan 11. |
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks' postmenstrual age as a sham subcutaneous dose |
| Completed Assessment for Bayley Cognitive Score at Two-Year Follow-Up |
|
| Died After Hospital Discharge |
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| Died Before Hospital Discharge |
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| Started Study Drug and Data Not Withdrawn Prior to Hospital Discharge |
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| Survived to Hospital Discharge (a Median of 94 Days) |
|
| COMPLETED | Complete data for Primary Outcome, Bayley Cognitive Score assessed at Two-Year Follow-up, with imputed scores for deaths occurring prior |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Darbepoetin | Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou |
| BG001 | Placebo | Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose |
| 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 | Age refers to the infant and is measured as gestational age in weeks | Mean | Standard Deviation | weeks |
| ||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Birth weight, Continuous | Mean | Standard Deviation | grams |
| |||||||||||||||
| Race, Customized | The subject's race is derived from the race of the biological mother | Count of Participants | Participants |
|
| 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 | Bayley III Composite Cognitive Score | Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score, where subjects who died prior to the follow-up assessment are assigned the lowest possible score of 54. This is a standardized scale where a score that is more than 1 normative standard deviation from the normative mean of 100 signifies mild developmental delay (score < 85); 2 standard deviations below the mean, moderate delay (score < 70); and 3 standard deviations below the mean, severe delay (score < 55). This self-standing scale comprises the primary outcome for the Darbe study. | The analysis population includes all randomized infants with available data up to the two-year followup. | Posted | Mean | Standard Deviation | score on a scale | 22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlier |
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| Secondary | Number of Transfusions Per Infant | The number of transfusions recorded during the study, up to 35 completed weeks gestational age | The analysis population includes all randomized infants with available data during the initial hospitalization. | Posted | Mean | Standard Deviation | Transfusions | Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks) |
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| Secondary | Total Volume of Transfusions Per Infant | The total volume of transfusions for the infant if ever transfused | The analysis population includes all randomized infants that were ever transfused. | Posted | Mean | Standard Deviation | mL | Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks) |
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| Secondary | Number of Donor Exposures Per Infant | The number of donor exposures recorded during the study, up to 35 completed weeks gestational age | The analysis population includes all randomized infants with available data during the initial hospitalization. | Posted | Mean | Standard Deviation | Donors | Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks) |
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| Secondary | Hematocrit | Hematocrit adjusted for center, gestational age group, and familial clustering | The analysis population includes all randomized infants with available data during the initial hospitalization. | Posted | Least Squares Mean | 95% Confidence Interval | Percent of blood volume made up of RBCs | at 2 and at 7 weeks in the study |
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| Secondary | Red Cell Mass | Red Cell Mass (Circulating Erythrocyte Volume), adjusted for center, gestational age group, and familial clustering | The analysis population includes all randomized infants with available data during the initial hospitalization. | Posted | Least Squares Mean | 95% Confidence Interval | mL | at 2 and at 7 weeks in the study |
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| Secondary | Necrotizing Enterocolitis, Bells Stage >=2 With Surgery | This is measured as Yes if experienced necrotizing enterocolitis, Bells stage >=2 with surgery; Otherwise, No. | The analysis population includes all randomized infants with available data during the initial hospitalization. | Posted | Count of Participants | Participants | Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days) |
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| Secondary | Bronchopulmonary Dysplasia Grades 2 or 3 | This is measured as Yes if infant is on invasive mechanical ventilation, nasal cannula >2 L/min or noninvasive positive airway pressure at 36 weeks of postmenstrual age; Otherwise, No. | The analysis population includes all randomized infants with available data during the initial hospitalization. | Posted | Count of Participants | Participants | At 36 weeks postmenstrual age |
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| Secondary | Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received | This is measured as Yes if experienced Retinopathy of prematurity stage >=3 or treatment for that condition received; Otherwise, No. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease. | The analysis population includes all randomized infants with available data during the initial hospitalization. | Posted | Count of Participants | Participants | Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days) |
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| Secondary | Intraventricular Hemorrhage Grade I+ | This is measured as Yes if experienced Grade I+ Intraventricular Hemorrhage; Otherwise, No. | The analysis population includes all randomized infants with available data during the initial hospitalization. | Posted | Count of Participants | Participants | Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days) |
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| Secondary | Length of Hospital Stay | This is measured as the length of stay up to hospital discharge or death, whichever occurred first. | The analysis population includes all randomized infants with available data during the initial hospitalization. | Posted | Mean | Standard Deviation | Days | At initial hospital discharge or at death if it occurs earlier (a median of 94 days), assessed up to one year of life. |
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| Secondary | Death | This is measured as Yes if an infant died between birth and 22-26 months corrected age; Otherwise, No. | The analysis population includes all randomized infants with available data up to the two-year followup. | Posted | Count of Participants | Participants | Birth, through the 22-26 months corrected age follow-up window, which corresponds to a median of 29 months calendar age in the analysis population |
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| Secondary | Neurodevelopmental Impairment | This is a 4-level outcome, where Severe NDI denotes a BSID III cognitive score less than 70, a Gross Motor Functional (GMF) level of 3-5 (where higher scores indicate worse outcomes), blindness (less than 20/200 vision), and/or profound hearing loss, Moderate NDI denotes a BSID III cognitive score from 70-84 and either a GMF level of 2 or limited blindness / moderate hearing loss, Mild NDI denotes a BSID III cognitive score from 70-84, or a cognitive score >=85 with a GMF level of 1 and/or mild hearing loss, and No NDI denotes a cognitive score >= 85 and an absence of neurosensory deficits. | The analysis population includes all randomized infants with available data at the two-year followup. | Posted | Count of Participants | Participants | At 22-26 months corrected age (a median of 25 months corrected age) |
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| Secondary | Any Cerebral Palsy | This is measured as Yes if the child has been deemed by the medical examiner as having Cerebral Palsy; Otherwise, No. | The analysis population includes all randomized infants with available data at the two-year followup. | Posted | Count of Participants | Participants | At 22-26 months corrected age (a median of 25 months corrected age) |
|
|
SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Darbepoetin | Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age, intravenously when the infant had intravenous access, otherwise subcutaneously | 52 | 319 | 85 | 316 | 16 | 316 |
| EG001 | Placebo | Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose | 53 | 327 | 92 | 325 | 21 | 325 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute anemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DIC | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Twin-twin transfusion syndrome | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiopulmonary arrest | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ventricular dysfunction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Congenital anomaly | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Newborn persistent pulmonary hypertension | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Esophageal perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intra-abdominal hemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Necrotizing enterocolitis neonatal | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neonatal intestinal perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Direct hyperbilirubinemia | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Failure liver | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Aspergillosis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Enterovirus infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Neonatal sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Staphylococcus aureus pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Stoma site bleeding | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebrospinal fluid volume increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intraventricular hemorrhage neonatal | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Posthaemorrhagic hydrocephalus | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Extreme immaturity | Pregnancy, puerperium and perinatal conditions | MedDRA 17.1 | Systematic Assessment |
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| Anuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute lung injury | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute respiratory decompensation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Syndrome respiratory distress newborn | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hemorrhage | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypertension neonatal | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis neonatal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin K Ohls, MD | University of Utah | 801-581-7052 | robin.ohls@hsc.utah.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2023 | Jun 14, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2019 | Jun 15, 2026 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| D000077330 | Saline Solution |
| D009934 | Organization and Administration |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D006298 | Health Services Administration |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian, Native Hawaiian, or Other Pacific Islander |
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| Black or African American |
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| More Than One Race |
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| Unknown or Not Reported |
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| White |
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| Units | Counts |
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| Participants |
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