Phase 3 N=91 Saizen in Intra-uterine Growth Retardation
Children Born With Serious Intra-uterine Growth Retardation
Primary: Final Height — 145.90; 150.06; 153.27; 155.59 cm
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=3,188 Low-birthweight Infant Feeding Exploration
Low Birthweight · Pre-Term
Primary: Length-for-Age Z-score — -1.43 Z-score
N/A N=5 Randomized Clinical Trial: Expectant Management vs Laser Treatment of Monochorionic Twins With Severe Selective Intrauterine Growth Retardation and Absent or Reverse Diastolic Flow in the Umbilical Artery
Intrauterine Growth Retardation
Primary: Survival — 100; 100 percentage of AGA babies who survived
Phase 3 N=208 Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Growth Disorders · Intrauterine Growth Retardation
Primary: Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm — 3.07; 3.97; 2.84 cm/year — p=0.02922
N/A N=60 Predicting Placental Pathologies by Ultrasound Imaging
Intrauterine Growth Restriction · Villitis · IUGR
Primary: Number of Participants With Uterine Artery Indices Completed — 13; 3 Participants
Phase 3 N=46 Growth Retardation In Children With Special Pathological Conditions Or Disease
Endocrine System Diseases
Primary: Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population — -1.29; 2.36 SDS
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
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=136 Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
Growth Disorders · Insulin-Like Growth Factor-1 Deficiency
Primary: Height Velocity During the First Year - Intent to Treat (ITT)Population — 5.2; 6.9; 7.7 cm/yr — p=<0.0001
Phase 3 N=43 Genotropin Treatment In Very Young Children Born Small For Gestational Age
Infant, Small for Gestational Age
Primary: Change From Baseline in Height Standard Deviation Score (SDS) at Month 24. — 1.63; 0.43 SDS — p=<0.001
N/A N=813 Third Trimester Screening of Fetal Growth Restriction
Fetal Growth Retardation · Fetal; Slow Growth
Primary: Rate of Small for Gestational Age at Birth Identified Antenatally — 28; 46 Participants
Phase 3 N=98 Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
Foetal Growth Problem · Small for Gestational Age
Primary: Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years — -2.9488; -2.9047; 1.2066; 2.0247…
Phase 2 N=33 Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Growth Hormone Therapy · Infant, Very Low Birth Weight
Primary: Change in Height Standard Deviation Score (SDS) After 1 Year — 1.099; 0.108 centimeters — p=<0.001
Phase 4 N=61 Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
Short Stature Born Small for Gestational Age (SGA)
Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 27; 31; 10; 5 participant
Phase 3 N=92 Long-Term Treatment With rhIGF-1 in GHIS
Growth Hormone Insensitivity Syndrome
Primary: Annualized Height Velocity Up to 12 Years — 2.6; 8.0; 5.9; 5.5 centimeter per year (cm/y)
N/A N=187 GER Poses a Potential Risk for Late Complications of BPD
Gastroesophageal Reflux · Bronchopulmonary Dysplasia
Primary: the Late Complications of BPD Infants — 57; 45; 30; 4 Participants
Phase 4 N=278 Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
Small for Gestational Age
Primary: Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment — 0 Participants
Phase 3 N=57 Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
Fetal Growth Retardation
Primary: Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months — 86.0; 14.0 percentage of participants
Phase 2 N=7 IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency
Short Stature
Primary: Height Velocity — 3.0; 4.3; 6.2; 4.8 cm/y
N/A N=324 Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children
Malnutrition · Developmental Disabilities
Primary: Change in Height/Length for Age Z Score — -0.02; 0.05 Z scores
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=39 Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism
Pseudohypoparathyroidism · Albright Hereditary Osteodystrophy
Primary: Intelligence Quotient — 85.9; 104.3; 103.2 units on a scale
Early Phase 1 N=3 Placental Lesions in Fetal Growth Restrictions
Fetal Growth Retardation
Primary: Number of Participants for Which Intervillous Placental Blood is Detected — 3 Participants
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=70 Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands
Polycystic Ovary Syndrome
Primary: Estradiol Level in Female Offspring — 18606; 6467 pg/ml — p=0.049
N/A N=605 Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
Neurodevelopmental Abnormality
Primary: Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition. — 55; 55; 60; 60 score on a scale — p=0.87
N/A N=909 Long Term Use of Somatropin in Patients Small for Gestational Age
Small for Gestational Age
Primary: Number of Participants With Treatment Related Adverse Events. — 44 participants
Phase 3 N=22 Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Small Gestational Age (SGA)
Primary: Height Velocity — 6.40; 4.40 centimeter (cm)/year — p=0.001
N/A N=39 ABCA3 Gene and RDS in Late Preterm and Term Infants
Respiratory Distress Syndrome, Newborn
Primary: Mortality — 5; 3; 5 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