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
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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
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=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
N/A N=90 Fibroblast Growth Factors 19 and 21 in Gestational Diabetes Mellitus
Gestational Diabetes Mellitus
Primary: The Concentration of Serum FGF19 — 65.96; 124.47 pg/mL
Phase 1 N=22 PED NEONAT 20-000599 Fetal Body Composition
IUGR · Gestational Diabetes · Pregnancy Related
Primary: Maternal Visceral Adipose Tissue Volume — 97593; 169626; 96787 mm3
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
N/A N=43 Auto-PAP Therapy For Improved Fetal Growth
Obstructive Sleep Apnea · Pregnancy
Primary: Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester — 8; 8 Participants — p=0.92
N/A N=206 Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial
Uncomplicated Pregnancy · Abnormal Fetal Growth or Fluid
Primary: Number of Participants With Fetal Growth Restriction — 2; 8 Participants
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
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
N/A N=47 Antecedents of Obesity: Fetal Measures of Adiposity
Obesity
Primary: Infant Adiposity at 24-72 Hours Following Birth — 11 Percentage of total body weight
N/A N=281 Maternal-Offspring Metabolics:Family Intervention Trial
Pregnancy · Weight Gain
Primary: Gestational Weight Gain (GWG) — 12; 10 kg — p=0.01
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
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=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 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=60 Dysregulation of FSH in Obesity: Functional and Statistical Analysis
Obesity · Fertility
Primary: Difference Between Peak Inhibin B — 100.8; 38.8 picograms/mL
Phase 2 N=5 'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial
Hernia · Hernia, Diaphragmatic · Hernia, DIaphragmatic, Congenital
Primary: Proportion of Neonate Survival at Discharge From Hospital — 1; 3 Participants
N/A N=90 FGF-21 Levels and RMR in Children and Adolescents With Hashimoto's Thyroiditis (THYROMETABOL)
Hashimoto Disease
Primary: Fibroblast Growth Factor 21 (FGF-21) — 182.71; 217.36; 198.43 pg/mL
Phase 3 N=98 Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
Growth Hormone Deficiency
Primary: Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population — -2.91; 0.80 Standard Deviation Score…
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 2 N=30 Treatment of Rett Syndrome With Recombinant Human IGF-1
Rett Syndrome
Primary: Rett Syndrome Behavior Questionnaire (RSBQ) - Fear/Anxiety Subscale — 4.00; 5.00; 5.00; 3.00 units on a scale
N/A N=51 Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion
Gestational Weight Gain · Maternal Fat Accretion · Infant Fat Accretion
Primary: Maternal Weight Changes — 70.20; 66.47; 80.12; 75.80 kg
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…
N/A N=39 Fetal and Neonatal Magnetophysiology
Fetal Arrhythmia · Abnormality in Fetal Heart Rate or Rhythm · Long QT Syndrome
Primary: Percentage of Subjects Experiencing Symptoms — 0; 0 Participants
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
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
Phase 3 N=113 Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
Fibromyalgia
Primary: Percentage of Participants With Less Than 11 Tender Points at Month 6 — 20; 22 Percentage of participants
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