Clinical trials: Infants Growth
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cystic Fibrosis
The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis
The purpose of this randomized, placebo-controlled (Phase II) study will be to further evaluate the effects of oral glutathione on growth in children with CF.
- Trial name
- GROW (NCT03020719)
- Testing
- Oral Glutathione
- Where
- 18 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Minnesota
Diarrhea
PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa
The objective of the project is to develop and test an intervention to promote exclusive breastfeeding (EBF), to assess its impact on infant health in African contexts where a high prevalence of HIV is a barrier, and to…
- Trial name
- NCT00397150
- Testing
- Peer-support for exclusive breastfeeding
- Where
- 4 sites in Burkina Faso, South Africa and 2 more
- Volunteers
- 2,579 people, healthy volunteers welcome
- Sponsor
- Centre For International Health
Coarctation of the Aorta, Pulmonary Artery Stenosis
Growth Trial: Study of the Renata Minima Stent
The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e.…
- Trial name
- NCT05086016
- Testing
- Catheterized Stenting
- Where
- 7 sites in United States
- Volunteers
- 42 people
- Sponsor
- Renata Medical
Postnatal Growth Disorder
Physiologic Approach to Sodium Supplementation in Premature Infants
Postnatal growth failure occurs in up to 50% of very low birth weight (VLBW, <1500 grams at birth) infants as assessed by discharge weight.
- Trial name
- Salt to Grow (NCT03889197)
- Testing
- Sodium supplementation guided by urine sodium concentration algorithm
- Where
- 3 sites in United States
- Volunteers
- 90 people
- Sponsor
- Indiana University
Infant, Small for Gestational Age, Infant, Low Birth Weight
KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section
This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help…
- Conditions
- Infant, Small for Gestational Age, Infant, Low Birth Weight, Pregnancy, Sleep
- Trial name
- KBTH-HBWS (NCT03062228)
- Where
- Ghana
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- IWK Health Centre
Growth Hormone Therapy, Infant, Very Low Birth Weight
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
- Trial name
- AGA (NCT00174460)
- Testing
- Somatropin, Control Arm
- Where
- 8 sites in Germany
- Volunteers
- 33 people
- Sponsor
- Pfizer
Development, Vitamin Deficiency
Vitamin B12, Neurodevelopment and Growth in Nepal
Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of Vitamin B12 is animal-source foods.
- Conditions
- Development, Vitamin Deficiency, Malnutrition
- Trial name
- BeLive (NCT02272842)
- Testing
- Vitamin B12
- Where
- Nepal
- Volunteers
- 600 people
- Sponsor
- Centre For International Health
Human Milk, Neonate
Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU
This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth.
- Conditions
- Human Milk, Neonate, Breast Milk
- Trial name
- NCT04025021
- Testing
- Targeted Fortification, The Miris Human Milk Analyzer
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- MetroHealth Medical Center
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
Development
Effect of Infant Formula on Energy Balance
The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and…
- Trial name
- GRO (NCT01700205)
- Testing
- Type of Formula
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Monell Chemical Senses Center
Overweight and Obesity
Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth
The purpose of this voluntary research study is to determine if calibrated formula feeding recommendations can promote optimal growth for the first 6 months after birth for mothers with a pre-pregnancy body mass index of 25 or…
- Trial name
- NCT05104073
- Testing
- Intervention
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Milton S. Hershey Medical Center
Premature Infants, Stool Bacterial Composition
Effects of Probiotic and Prebiotic Combinations on Premature Infants
The purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants.
- Conditions
- Premature Infants, Stool Bacterial Composition, Growth
- Trial name
- NCT00282113
- Testing
- ProBioPlus, Culturelle
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Prematurity; Extreme, Feeding Disorder Neonatal
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z…
- Conditions
- Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure
- Trial name
- NCT04325308
- Testing
- Protein-enriched human milk diet, Usual human milk diet
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Infant, Very Low Birth Weight
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk.
- Trial name
- NCT02573779
- Testing
- Observational - no intervention
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Baylor College of Medicine
Sleep, Pregnancy
Halifax PrenaBelt Trial
Back and right-sided sleeping position in pregnant women has recently emerged as a potential risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature.
- Conditions
- Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight
- Trial name
- NCT02377817
- Testing
- PrenaBelt
- Where
- Canada
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Allan Kember
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
Retinopathy of Prematurity (ROP)
IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
To compare the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for gestational age at birth while confirming the dose of rhIGF-1/rhIGFBP-3 is safe and efficacious.
- Trial name
- NCT01096784
- Testing
- rhIGF-I/rhIGFBP-3
- Where
- 24 sites in United States, Italy and 4 more
- Volunteers
- 121 people
- Sponsor
- Shire
Retinopathy of Prematurity
Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study
In premature infants, propranolol (Prop) treatment might suppress continuing neo-vascularization (NV) and decelerate the progression of retinopathy of prematurity (ROP) towards its severe stages (III-V), thus avoiding the need of…
- Trial name
- NCT01238471
- Testing
- propranolol, sucrose 5%
- Where
- 4 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Rambam Health Care Campus
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