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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD067126 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Mercy Medical Center | OTHER |
| Johns Hopkins University | OTHER |
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The purpose of this study is to determine whether intravenous azithromycin is effective in eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation.
The study design will be a double-blind, placebo-controlled clinical trial to test the efficacy and safety of azithromycin 20 mg/kg x 3 days to eradicate Ureaplasma spp from the respiratory tract of preterm infants 24 weeks 0 days to 28 weeks 6 days gestation exposed to positive pressure ventilation. The primary outcome will be survival with microbiological eradication of Ureaplasma defined as survival to discharge or transfer with 3 negative cultures obtained post-therapy. Secondary outcomes will include physiologic BPD at 36 weeks post-menstrual age (PMA), overall mortality, incidence of co-morbidities of prematurity such as intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, bacterial and fungal nosocomial infection, pulmonary air leak, patent ductus arteriosus, retinopathy of prematurity, number of days of positive pressure ventilation, number of days of oxygen supplementation, use of postnatal steroids, and use of non-study antibiotics. At 6 and 18 months adjusted age, a pulmonary outcome questionnaire will be administered by phone or in person interview. At 18-22 months adjusted age, neurodevelopmental outcomes will be assessed by 1) Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III); 2) Amiel-Tison neurologic examination; 3) Gross Motor Function Classification System; and 4) medical record review for hearing impairment with or without amplification and vision impairment (vision <20/200).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (5% dextrose) | Placebo Comparator | Placebo |
|
| Azithromycin | Experimental | Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Azithromycin intravenous 20 mg/kg every 24 h x 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma | Bacterial clearance (eradication) will be defined as 3 negative cultures obtained 2 and 5 days post-third dose and 21 d of age. Survival is defined as survival at time of discharge or transfer from the neonatal intensive care unit (NICU). | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age | Number of Participants who survived until 36 wks postmenstrual age with Physiologic defined bronchopulmonary dysplasia (BPD) based on oxygen-saturation monitoring | 36 weeks post menstrual age (one month prior to due date) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Threshold Retinopathy of Prematurity (ROP) | Threshold ROP requiring surgical intervention as diagnosed by ophthalmologic examination | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
| Number of Participants With Necrotizing Enterocolitis (NEC) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rose M Viscardi, M.D. | University of Maryland, College Park | Study Chair |
| Pamela Donohue, ScD | Johns Hopkins University | Principal Investigator |
| Namasivayam Ambalavanan, M.D. | University of Alabama at Birmingham | Principal Investigator |
| David A Kaufman, M.D. | University of Virginia | Principal Investigator |
| Michael L Terrin, M.D. | University of Maryland, College Park | Principal Investigator |
| Susan J Dulkerian, M.D. | Mercy Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249-7335 | United States | ||
| Christiana Care Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21098694 | Background | Hassan HE, Othman AA, Eddington ND, Duffy L, Xiao L, Waites KB, Kaufman DA, Fairchild KD, Terrin ML, Viscardi RM. Pharmacokinetics, safety, and biologic effects of azithromycin in extremely preterm infants at risk for ureaplasma colonization and bronchopulmonary dysplasia. J Clin Pharmacol. 2011 Sep;51(9):1264-75. doi: 10.1177/0091270010382021. Epub 2010 Nov 23. | |
| 32170033 | Derived | Viscardi RM, Terrin ML, Magder LS, Davis NL, Dulkerian SJ, Waites KB, Ambalavanan N, Kaufman DA, Donohue P, Tuttle DJ, Weitkamp JH, Hassan HE, Eddington ND. Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):615-622. doi: 10.1136/archdischild-2019-318122. Epub 2020 Mar 13. |
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Recruitment period July 1, 2013- August 31, 2016 at 7 U.S. hospital Neonatal Intensive Care Units (NICUs).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (5% Dextrose) | Placebo Placebo: D5W 10 ml/kg every 24 h x 3 days |
| FG001 | Azithromycin | Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2017 |
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| University of Virginia |
| OTHER |
| University of Alabama at Birmingham | OTHER |
| Christiana Care Health Services | OTHER |
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| Placebo | Drug | D5W |
|
|
| Number of Participants With Death or Neurodevelopmental Impairment | Neurodevelopmental impairment will be assigned if any of the following are present at 22-26 months adjusted age: moderate to severe cerebral palsy, bilateral blindness, bilateral hearing impairment requiring amplification, Gross Motor Function Classification System score ≥ 2, or Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III) cognitive or motor score <70. | 22-26 months |
| Number of Participants With Pulmonary Impairment | Parent report of recurrent wheezing and/or chronic cough | 6-26 months |
| Number of Participants Who Died | Number of Participants who died from any cause | 22-26 months |
| Duration of Positive Pressure Support | Combined number of days receiving mechanical ventilation plus non-invasive modes of positive pressure support. | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
| Duration of Oxygen Supplementation | Cumulative number of days of receipt of supplemental oxygen | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
| Number of Participants Who Experienced Air Leaks | Any pulmonary air leak (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum) confirmed by chest x-ray | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
| Number of Participants Who Received Postnatal Steroids | Receipt of steroid medications (hydrocortisone, dexamethasone) | 36 weeks |
| Number of Participants Who Received Non-Study Antibiotics | Received Non-study antibiotics following study drug intervention period. | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
| Pharmacokinetics (PK)/Pharmacodynamics (PD) Modelling of Time Course of Azithromycin Plasma Concentrations | Number of serum azithromycin concentrations that fell outside the 90% prediction interval determined by 200 simulated replicates based on the population PK of azithromycin in preterm infants. | Study day 1-day 7 |
Necrotizing enterocolitis ≥ Bell Stage II by radiographic and clinical criteria. |
| Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
| Number of Participants With Infections During the NICU Hospitalization | Culture-confirmed bacterial or fungal infection based on culture from sterile site (blood, cerebral spinal fluid, or urine) | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
| Number of Participants With Severe Intraventicular Hemorrhage (IVH) | Number of Participants with Grade III or IV IVH confirmed by cranial ultrasound | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
| Number of Participants With Periventricular Leukomalacia (PVL) | The number of Participants with cranial ultrasound confirmed PVL | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
| Number of Participants With Patent Ductus Arteriosus (PDA) | Detection of PDA by cardiac echocardiogram with left to right shunting, or clinical evidence of murmur, bounding pulses, and widened pulse pressure. | 14 days |
| Number of Participants With Cardiac Arrhythmia | Number of Participants with EKG evidence of prolonged QT (QTc > 450 ms) | 3 days |
| Newark |
| Delaware |
| 19713 |
| United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232-9544 | United States |
| University of Virginia | Charlottesville | Virginia | 22908-0386 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (5% Dextrose) | Placebo Placebo: D5W 10 ml/kg every 24 h x 3 days |
| BG001 | Azithromycin | Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days |
| 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 | gestational age in weeks | Mean | Standard Deviation | weeks gestation |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Ureaplasma-positive | Any subject who had a respiratory sample (tracheal aspirate and/or nasopharyngeal aspirate) at any time point that was positive for Ureaplasma species confirmed by culture and/or PCR was considered a Ureaplasma-positive subject. | 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 | Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma | Bacterial clearance (eradication) will be defined as 3 negative cultures obtained 2 and 5 days post-third dose and 21 d of age. Survival is defined as survival at time of discharge or transfer from the neonatal intensive care unit (NICU). | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age | Number of Participants who survived until 36 wks postmenstrual age with Physiologic defined bronchopulmonary dysplasia (BPD) based on oxygen-saturation monitoring | Participants who survived until assessment timepoint 36 weeks post menstrual age (1 month before due date) | Posted | Count of Participants | Participants | 36 weeks post menstrual age (one month prior to due date) |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Death or Neurodevelopmental Impairment | Neurodevelopmental impairment will be assigned if any of the following are present at 22-26 months adjusted age: moderate to severe cerebral palsy, bilateral blindness, bilateral hearing impairment requiring amplification, Gross Motor Function Classification System score ≥ 2, or Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III) cognitive or motor score <70. | Participants who died prior to the 22-26 months assessment timepoint and participants who were assessed for neurodevelopmental impairments | Posted | Count of Participants | Participants | 22-26 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Pulmonary Impairment | Parent report of recurrent wheezing and/or chronic cough | All participants enrolled and randomized in the trial | Posted | Count of Participants | Participants | 6-26 months |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died | Number of Participants who died from any cause | Posted | Count of Participants | Participants | 22-26 months |
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| Secondary | Duration of Positive Pressure Support | Combined number of days receiving mechanical ventilation plus non-invasive modes of positive pressure support. | Posted | Median | Inter-Quartile Range | days | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Oxygen Supplementation | Cumulative number of days of receipt of supplemental oxygen | Posted | Median | Inter-Quartile Range | days | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced Air Leaks | Any pulmonary air leak (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum) confirmed by chest x-ray | The participants who had air leak at baseline (prior to randomization) were excluded from analysis (3 placebo and 5 azithromycin). | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Received Postnatal Steroids | Receipt of steroid medications (hydrocortisone, dexamethasone) | Posted | Count of Participants | Participants | 36 weeks |
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| Secondary | Number of Participants Who Received Non-Study Antibiotics | Received Non-study antibiotics following study drug intervention period. | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
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| Secondary | Pharmacokinetics (PK)/Pharmacodynamics (PD) Modelling of Time Course of Azithromycin Plasma Concentrations | Number of serum azithromycin concentrations that fell outside the 90% prediction interval determined by 200 simulated replicates based on the population PK of azithromycin in preterm infants. | No plasma samples from placebo group were analyzed for azithromycin concentrations | Posted | Number | serum conc outside predicted interval | Study day 1-day 7 | number of serum samples concentrations | number of serum samples concentrations |
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| Other Pre-specified | Number of Participants With Threshold Retinopathy of Prematurity (ROP) | Threshold ROP requiring surgical intervention as diagnosed by ophthalmologic examination | The number of participants who survived to receive at least 1 eye exam for retinopathy of prematurity | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
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| Other Pre-specified | Number of Participants With Necrotizing Enterocolitis (NEC) | Necrotizing enterocolitis ≥ Bell Stage II by radiographic and clinical criteria. | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
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| Other Pre-specified | Number of Participants With Infections During the NICU Hospitalization | Culture-confirmed bacterial or fungal infection based on culture from sterile site (blood, cerebral spinal fluid, or urine) | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
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| Other Pre-specified | Number of Participants With Severe Intraventicular Hemorrhage (IVH) | Number of Participants with Grade III or IV IVH confirmed by cranial ultrasound | The participants who had a Grade III or IV IVH at baseline (prior to randomization) were excluded (2 placebo and 4 Azithromycin). | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
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| Other Pre-specified | Number of Participants With Periventricular Leukomalacia (PVL) | The number of Participants with cranial ultrasound confirmed PVL | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Patent Ductus Arteriosus (PDA) | Detection of PDA by cardiac echocardiogram with left to right shunting, or clinical evidence of murmur, bounding pulses, and widened pulse pressure. | Participants who did not have PDA at baseline (prior to randomization). Participants with PDA at baseline were excluded from analysis (5 placebo and 5 azithromycin. | Posted | Count of Participants | Participants | 14 days |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Cardiac Arrhythmia | Number of Participants with EKG evidence of prolonged QT (QTc > 450 ms) | Posted | Count of Participants | Participants | 3 days |
|
|
3 years 6 months
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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 | Placebo (5% Dextrose) | Placebo Placebo: D5W 10 ml/kg every 24 h x 3 days | 6 | 61 | 39 | 61 | 51 | 61 |
| EG001 | Azithromycin | Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days | 5 | 60 | 44 | 60 | 51 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Breathing pause > 20 seconds |
| |
| Patent Ductus Arteriosus | Cardiac disorders | Systematic Assessment | Patent ductus arteriosus confirmed by cardiac echocardiography |
| |
| Necrotizing enterocolitis | Gastrointestinal disorders | Systematic Assessment | Necrotizing enterocolitis Bell Stage ≥2 |
| |
| Intestinal Perforation | Gastrointestinal disorders | Systematic Assessment |
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| Ileal stricture | Gastrointestinal disorders | Systematic Assessment |
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| Cholestasis | Hepatobiliary disorders | Systematic Assessment |
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| Retinopathy of prematurity | Eye disorders | Systematic Assessment | Retinopathy of prematurity (ROP) >Stage 2 |
| |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | hematocrit <25 |
| |
| White blood cell count >40,000 cells/mm3 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment | platelet count <50,000 |
| |
| Sepsis | Infections and infestations | Systematic Assessment | Positive culture from a sterile site (blood or spinal fluid) |
| |
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Blood Urea Nitrogen > 60 mg/dL | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment | Serum calcium level >12.2 mg/dL |
| |
| Hypochloremia | Metabolism and nutrition disorders | Systematic Assessment | Serum chloride <80 mEq/L |
| |
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment | Serum sodium >155 mEq/L |
| |
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment | Serum potassium <2.4 mEq/L |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment | Serum sodium <121 mEq/L |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IV site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Gastric residual >50% volume of feed | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment | Abdominal girth increase > 2cm from baseline |
| |
| Loose stools | Gastrointestinal disorders | Systematic Assessment | stool consistency change with more water content <48 h duration |
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| Oral thrush | Infections and infestations | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment | white blood cell count >20,000 and <40,000 cells/mm3 |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment | platelet count <100,000 and >50,000 cells/mm3 |
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| Abnormal liver function test | Hepatobiliary disorders | Systematic Assessment | Serum liver function test (AST/ALT/ or alkaline phosphatase) 1.5-3.5X normal value |
| |
| conjugated hyperbilirubinemia | Hepatobiliary disorders | Systematic Assessment | Direct bilirubin 1.0-2.0 mg/dL |
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| Elevated serum creatinine | Renal and urinary disorders | Systematic Assessment | Serum creatinine 1.3-2.3 mg/dL |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment | hematocrit <35% and >25% |
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| metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment | Serum bicarbonate <22 and >14 mEq/L |
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| Metabolic alkalosis | Metabolism and nutrition disorders | Systematic Assessment | Serum bicarbonate >30 and <46 mEq/L |
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| Elevated Blood Urea Nitrogen | Metabolism and nutrition disorders | Systematic Assessment | Serum BUN >27 and <60 mg/dL |
| |
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment | Serum potassium >5.5 and <6.9 mEq/L |
| |
| Hyperbilirubinemia | Hepatobiliary disorders | Systematic Assessment | Total bilirubin > 7 and <14 mg/dL |
| |
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment | Serum sodium <132 and >120 mEq/dL |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rose Marie Viscardi, M.D. | University of Maryland | 410-706-1913 | rviscard@som.umaryland.edu |
| Feb 16, 2018 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2017 | Feb 16, 2018 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016869 | Ureaplasma Infections |
| D047928 | Premature Birth |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D009180 | Mycoplasmatales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| number of serum samples concentrations |
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