N/A N=248 Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
Preterm Infant
Primary: Index of Multisensory Processing (IMP) — 31.4; 49.0; 35.6; 18.8 percentage of time
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N/A N=20 A Novel Parent Education Program for Early Intervention
Preterm Infant · Full-term Infant
Primary: Alberta Infant Motor Scale - Change in Total Percentile Score — 10; 0 change in percentile rank — p=0.016
N/A N=995 Neonatal Outcome by Reason for Delivery
Preterm Delivery
Primary: Composite Perinatal Morbidity — 277; 203; 221; 45 participants
N/A N=198 Feeding and Transition to Home for Preterms at Social Risk
Premature Birth
Primary: Infant Behavioral Organization — 33.2; 51.8 Orally directed behavioral cues per week
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=3,188 Low-birthweight Infant Feeding Exploration
Low Birthweight · Pre-Term
Primary: Length-for-Age Z-score — -1.43 Z-score
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=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=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
N/A N=103 PREterM FOrmula Or Donor Breast Milk for Premature Babies
Adiposity · Insulin Resistance · Metabolomic Profile
Primary: Total Body Adiposity — 0.893; 0.863; 0.809 Litres
Phase 4 N=31 Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Preterm Birth · Child Development · Child Behavior
Primary: Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2 — -1.0; -0.2 score on a scale — p=0.67
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=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=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 4 N=21 Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Caffeine
Primary: Intubation — 3; 7 participants
N/A N=64 PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
Premature Infant Disease · Family Research · Parent-Child Relations
Primary: Maternal Self-Rating of Depression — -3.75; -4.08; -2.21; -2.50 T-score mean changes
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
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=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=90 Effects of Probiotic and Prebiotic Combinations on Premature Infants
Premature Infants · Stool Bacterial Composition · Growth
Primary: Weight Gain — 618; 590; 682 Grams — p=>0.5
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
N/A N=34 Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Bronchopulmonary Dysplasia
Primary: Number of Days Being Intubated — 12.4; 6.2 days
N/A N=70 NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
Cerebral Palsy · Prematurity · Early Intervention
Primary: Acceptability — 70 Participants
N/A N=45 A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
Preterm Birth · Healthy
Primary: Number of Chats on Sleep, Stress and Infant Nutrition — 131; 125 Chats
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=100 Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function
Neonatal · Premature Birth · Respiratory Distress Syndrome
Primary: Alveolar Volume — 500.2; 418.1 mL — p=<0.05
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 4 N=52 Early Sodium Intake in Preterm Newborns
Hyponatremia · Premature
Primary: Hyponatremia — 6; 1 Participants — p=0.71
Phase 3 N=286 Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
Infections, Streptococcal
Primary: Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off — 5; 2; 1; 1 Participants
N/A N=121 Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants
Infant, Extremely Low Birth Weight · Feeding Behavior
Primary: Salivary Gene Expression — 21.344; 21.420; 20.931; 21.100 Delta-CT — p=<0.01