Phase 2 N=102 Darbepoetin Administration to Preterm Infants
Infant, Newborn
Primary: Number of Transfusions During Hospitalization — 1.2; 1.2; 2.4 number of transfusions
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N/A N=377 Age of Red Blood Cells in Premature Infants Study (ARIPI)
Premature Birth
Primary: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality…
Phase 3 N=150 Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants
Anemia
Primary: Hematocrit (Hct) — 29.2; 28.3 percentage of red blood cells in blood
N/A N=150 Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
Iron Deficiency Anemia
Primary: Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA) — 29.2; 28.2 % Hematocrit — p=0.59
N/A N=1,824 Transfusion of Prematures Trial
Infant, Newborn, Diseases · Infant, Extremely Low Birth Weight · Infant, Small for Gestational Age
Primary: Death or Neurodevelopmental Impairment — 423; 422; 422; 425 Participants — p=0.93
Phase 2 N=20 Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
Preterm Infants
Primary: Baseline Retic Count — 122; 140 x1000 cells/microliter
N/A N=25 Cord Blood Transfusion In Preterm Neonates (CB-TrIP)
Premature Infant Disease · Transfusion Related Complication · Fetal Hemoglobin
Primary: Median Percentage of HbF at 32 Weeks of Post Menstrual Age — 93.2; 90.8; 58.0; 69.0 percentage of total Hb — p=<0.0001
N/A N=77 Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
Prematurity
Primary: Full Scale IQ, Performance IQ, Verbal IQ, Executive Function — 79; 91; 103; 83 standardized score on a scale
N/A N=146 Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
Very Preterm Maturity of Infant · The Risk Factors for Improving the Prognosis of VLBW Infants
Primary: The Incidence of Early Onset Sepsis in VLBW Infants With AOP. — 18; 34; 7; 42 Participants
Phase 4 N=38 Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial
Iron Deficiency Anemia of Pregnancy · Iron Malabsorption
Primary: Maternal Anemia at Delivery — 4; 11 Participants — p=0.039
Phase 3 N=650 Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
Neurocognitive · Neuroprotective · Neonatal
Primary: Bayley III Composite Cognitive Score — 80.7; 80.1 score on a scale — p=0.88
N/A N=8 Transfusions and Nitric Oxide Level in Preterm Infants
Prematurity · Anemia · Necrotizing Enterocolitis
Primary: SNOHgB Levels
Phase 2 N=104 Red Blood Cell (RBC) Survival Following Transfusion in Infants
Neonatal Anemia
Primary: Number of Discrete Biotinylated RBC Densities (up to 5 Discrete Densities) That Can be Accurately Measured by Flow Cytometry, i.e., Without Overlap. — 5; 5 flow…
N/A N=150 IV Iron for the Anemia of Traumatic Critical Illness
Trauma · ICU Anemia
Primary: RBC Transfusion — 47; 55 participants
Phase 3 N=941 Preterm Erythropoietin Neuroprotection Trial (PENUT Trial)
Extreme Prematurity
Primary: Number of Participants With Death or Severe Neurodevelopmental Impairment (NDI) at 22-26 Months Corrected Age — 94; 97 Participants — p=0.05
N/A N=111 Cerebral Oxygenation and Autoregulation in Preterm Infants
Intraventricular Hemorrhage of Prematurity · Complications of Prematurity
Primary: Mortality Before Hospital Discharge — 11 Participants
Phase 3 N=500 High-dose Erythropoietin for Asphyxia and Encephalopathy
Neonatal Encephalopathy · Birth Asphyxia
Primary: Number of Participants With Death or Neurodevelopmental Impairment — 126; 110 Participants
Phase 4 N=46 Platelet Transfusion During Neonatal Open Heart Surgery
Cardiac Disease · Cardiac Surgery · Cardiopulmonary Bypass
Primary: Amount of Blood Products Transfused — 58; 103 milliliter per kilogram (mL/kg)
Phase 2 N=100 Practical Anemia Bundle for SusTained Blood Recovery
Anemia · Critical Illness
Primary: Hemoglobin Concentrations — 11.5; 12.2 g/dL — p=0.02
Phase 2 N=28 Mild Encephalopathy in the Newborn Treated With Darbepoetin
Neonatal Encephalopathy · Hypoxic-Ischemic Encephalopathy Mild
Primary: Normal Neurodevelopment — 13; 14 Participants
Phase 2 N=121 IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
Retinopathy of Prematurity (ROP)
Primary: Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population — 14; 24; 4; 4 participants — p=0.0642
Phase 3 N=1,538 Age of Blood in Children in Pediatric Intensive Care Units
Anemia
Primary: Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) — 147; 133 Participants
N/A N=84 Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities
Respiratory Distress Syndrome
Primary: Respiratory Distress Syndrome — 52; 3 participants
Phase 4 N=40 Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia
Anemia, Iron Deficiency · Delivery Complication
Primary: Hemoglobin Level — 12; 12 grams/deciliters
N/A N=251 Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years
Iron Deficiency
Primary: The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. — 64; 71; 13; 10 participants — p=0.42
N/A N=995 Neonatal Outcome by Reason for Delivery
Preterm Delivery
Primary: Composite Perinatal Morbidity — 277; 203; 221; 45 participants
N/A N=66 SMaRT Blood: Single-unit Versus Multiple-unit Packed Red Blood Cell Transfusion in Non-acute Postpartum Anemia
Postpartum Anemia Nos
Primary: Total Number of Units Transfused — 1.2; 2.1 units of blood — p=<0.001
Phase 4 N=52 Early Sodium Intake in Preterm Newborns
Hyponatremia · Premature
Primary: Hyponatremia — 6; 1 Participants — p=0.71
N/A N=97,507 Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
Neonatal Death · Prematurity
Primary: Use of Parenteral Nutrition (Project A) — 62145 Participants
N/A N=102 Iron Parameters in Non-anemic First Trimester Gravidas
Iron Deficiency (Without Anemia) · Pregnancy
Primary: Percent of Non-anemic Patients With Iron Deficiency Stratified by Gravidity — 9; 3; 6; 38 Participants