N/A N=3,188 Low-birthweight Infant Feeding Exploration
Low Birthweight · Pre-Term
Primary: Length-for-Age Z-score — -1.43 Z-score
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N/A N=48 Very Low Birth Weight Preterm Infant Bundled Care in the NICU
Preterm Infants
Primary: Mean Heart Rate by Group — 200; 185 beats per minute
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=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=90 Physiologic Approach to Sodium Supplementation in Premature Infants
Postnatal Growth Disorder
Primary: Change in Somatic Growth (Weight) — 0.04; 0.16 score on a scale — p=0.162
N/A N=366 Incubator Weaning of Moderately Preterm Infants
Infant, Newborn · Infant, Moderate Preterm
Primary: Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days) — 43; 41 days
Phase 2 N=134 Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Feeding; Difficult, Newborn · Growth Failure · Necrotizing Enterocolitis
Primary: Time to Establish Full Enteral Feeds — 15; 15 days
Phase 3 N=483 Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
Infant, Newborn · Infant, Small for Gestational Age · Infant, Extremely Low Birth Weight
Primary: Bayley Scales of Infant Development (BSID) Cognitive Composite Score — 80.7; 81.1 Score on a scale
N/A N=168 Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
Prematurity
Primary: Number of Participants With Weight<10th Percentile for Age — 32; 41 Participants
N/A N=120 Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
Infant, Premature, Diseases · Infant, Small for Gestational Age
Primary: Growth Velocity — 13; 13.1 g kg-1 day-1
N/A N=20 Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants
Body Temperature
Primary: Mean Axillary Admission Temperature — 36.77; 36.68 Degrees Celsius — p=0.7294
N/A N=180 Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Breast Milk Expression
Primary: Pumped Milk Volume Day 1 — 3; 4; 5 mL — p=0.015
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
Phase 2 N=48 Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Extremely Low Gestational Age Newborn · Premature Infant
Primary: Urinary Secretary IgA Concentration at 2 Weeks of Age — 233.8; 48.3 ng per g creatinine — p=0.006
N/A N=65 Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
Preterm Infant · Early-Onset Neonatal Sepsis · Umbilical Cord
Primary: White Blood Cell Count (WBC) (1) — 8257 ratio of cells/mm3
N/A N=117 Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
Infant, Very Low Birth Weight
Primary: Intestinal Microbiome Diversity — 55.7; 46.3 taxa represented
N/A N=38 Feeding and Wellness Among Late Preterm Infants
Late Preterm Infant
Primary: Phone Call Completion Rate — 194; 102; 59; 52 calls
N/A N=460 Sustained Aeration of Infant Lungs Trial
Preterm Birth · Extreme Prematurity
Primary: Combined Outcome of Death or Bronchopulmonary Dysplasia — 125; 137 Participants
Phase 4 N=14 Preterm Infant Inhaled Albuterol Dosing
Bronchopulmonary Dysplasia · Very Low Birth Weight
Primary: Change in Respiratory Resistance — 0.011; 0.006; 0.014 cm h2o/mL/sec
N/A N=11 Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants
Plagiocephaly
Primary: Safety of Use of the Premie Pouch in VLBW Infants — 0 participants
Phase 3 N=144 Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants
Prematurity · Neurodevelopmental Disorder · Carnitine Deficiency
Primary: Time to Regain Birthweight in Infants Who Receive L-carnitine Supplementation Compared to Controls — 8.12; 8.4 days — p=<0.05
N/A N=995 Neonatal Outcome by Reason for Delivery
Preterm Delivery
Primary: Composite Perinatal Morbidity — 277; 203; 221; 45 participants
N/A N=30 PUFA Supplementation in Premature Infants
Premature, Extremely Low Birth Weight Infants · Polyunsaturated Fatty Acid Levels
Primary: Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels — 4.45; 4.02; 5.27; 20.3 weight % (g/100g)
N/A N=99 Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants
Prematurity
Primary: Concentration of APPs Before Oral Priming — 17; 22; 35; 42 femtomole (fmol)
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=28 Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants
Hypoplastic Left Heart Syndrome · Growth Failure
Primary: Weight Gain in Grams Per Day — 24.3; 23.6 grams/day — p=0.05
N/A N=70 Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants
Hypotension
Primary: Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life — 9; 9 participants
N/A N=24 Aerosolized Albuterol Use in Severe BPD
Severe Bronchopulmonary Dysplasia
Primary: Change in Expiratory Flow Between Pre and Post-medication Dosing — 0.38; 0.70; 0.45 L/min
Phase 3 N=1,579 Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
Staphylococcal Sepsis
Primary: The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35. — 85; 79 Participants
Phase 3 N=362 Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight
Candidiasis
Primary: Death or Candidiasis — 31; 37 participants