Clinical trials: Small-for-gestational Age
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Growth Hormone Therapy, Infant, Small for Gestational Age
Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy
The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.
- Trial name
- SGA-POWER (NCT00625872)
- Testing
- Somatropin
- Where
- 10 sites in Germany
- Volunteers
- 23 people
- Sponsor
- Pfizer
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Premature, Diseases, Infant, Small for Gestational Age
Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3)…
- Trial name
- NCT02372136
- Testing
- Individualized Nutrition, Optimized nutrition
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Texas Southwestern Medical Center
Infant Development, Infant,Premature
Movement-based Infant Intervention
The objective is to pilot test the effectiveness of an evidence-based intervention to promote positive neurodevelopmental outcomes in infants at risk for developmental delay.
- Conditions
- Infant Development, Infant,Premature, Infant, Very Low Birth Weight, Infant, Small for Gestational Age
- Trial name
- NCT03082313
- Testing
- Movement Intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Southern California
Children Born With Serious Intra-uterine Growth Retardation
Saizen in Intra-uterine Growth Retardation
Study of safety of Saizen® in children born with serious intra-uterine growth retardation (IUGR) treated to final height. An open, phase III study involving 17 centers in France.
- Trial name
- NCT01400698
- Testing
- Saizen® A, Saizen® B, Observation only
- Volunteers
- 91 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Small Gestational Age (SGA)
Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1 group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of Saizen® during 1 year to 1 group receiving…
- Trial name
- SGA OPTIMIS (NCT00249821)
- Testing
- Saizen®
- Volunteers
- 22 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infant, Newborn, Infant, Small for Gestational Age
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
- Trial name
- NCT01534481
- Testing
- Donor Milk, Preterm Formula
- Where
- 17 sites in United States
- Volunteers
- 483 people
- Sponsor
- NICHD Neonatal Research Network
Fetal Growth Retardation
Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.
- Trial name
- NCT00174252
- Testing
- Genotonorm (Somatropin)
- Where
- 22 sites in France
- Volunteers
- 57 people
- Sponsor
- Pfizer
SGA, Turner Syndrome
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature.
- Conditions
- SGA, Turner Syndrome, Noonan Syndrome, ISS
- Trial name
- REAL 9 (NCT05723835)
- Testing
- Somapacitan
- Where
- 18 sites in United States, Malaysia and 4 more
- Volunteers
- 47 people
- Sponsor
- Novo Nordisk A/S
Infant, Small for Gestational Age
Genotropin Treatment In Very Young Children Born Small For Gestational Age
To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.
- Trial name
- EGN (NCT00627523)
- Testing
- Genotropin (PN-180,307) Somatropin, Control-no treatment
- Where
- 17 sites in Belgium, Czechia and 7 more
- Volunteers
- 43 people
- Sponsor
- Pfizer
Infant, Newborn, Diseases, Other Preterm Infants
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24…
- Conditions
- Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth
- Trial name
- SUPPORT (NCT00233324)
- Testing
- Surfactant, Continuous Positive Airway Pressure (CPAP), Supplemental oxygen with target saturation of 85 to 89%
- Where
- 22 sites in United States
- Volunteers
- 1,316 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
Foetal Growth Problem, Small for Gestational Age
Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan.
- Trial name
- NCT00184717
- Testing
- somatropin
- Where
- Japan
- Volunteers
- 98 people
- Sponsor
- Novo Nordisk A/S
Infant, Small for Gestational Age
A Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA)
This open, multicentric, randomized, controlled study is planned to evaluate the correlation between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in SGA children.
- Trial name
- SAIZEN in SGA (NCT01067352)
- Testing
- Recombinant human growth hormone (r-hGH)
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Short Stature Born Small for Gestational Age (SGA)
Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
- Trial name
- NCT01859949
- Testing
- Genotropin (somatropin)
- Where
- 19 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Pfizer
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age
- Trial name
- NCT01245374
- Testing
- Norditropin NordiFlex®
- Where
- France
- Volunteers
- 103 people
- Sponsor
- Novo Nordisk A/S
Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight
Transfusion of Prematures Trial
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of…
- Conditions
- Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD)
- Trial name
- TOP (NCT01702805)
- Testing
- Liberal Cell Transfusion, Restricted red cell transfusion
- Where
- 20 sites in United States
- Volunteers
- 1,824 people
- Sponsor
- NICHD Neonatal Research Network
Short Stature Children Born Small for Gestational Age (SGA)
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already…
- Trial name
- NCT03878446
- Testing
- Somapacitan, Norditropin®
- Where
- 95 sites in United States, Algeria and 21 more
- Volunteers
- 62 people
- Sponsor
- Novo Nordisk A/S
Small for Gestational Age (SGA)
Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).
- Trial name
- NCT01897766
- Testing
- Somatropin
- Volunteers
- 482 people
- Sponsor
- Pfizer