Clinical trials: Infant Nutrition Disorders
Infant Mortality, Preterm Birth
Antenatal Micronutrient Supplementation and Infant Survival
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth…
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality
- Trial name
- JiVitA-3 (NCT00860470)
- Testing
- Iron (27 mg) - folic acid (600 ug), Multiple micronutrient
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 44,567 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Parenteral Nutrition Associated Cholestasis
Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
- Trial name
- NCT01601652
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Arthur J De Lorimier
Prader-Willi Syndrome
Intranasal Oxytocin for Infants With Prader-Willi Syndrome
The purpose of this study is to compare the change in suck and swallow competency from baseline to morning of day 6 with intranasal oxytocin spray vs placebo in infants/children with Prader-Willi Syndrome who are in nutritional…
- Trial name
- NCT03245762
- Testing
- Oxytocin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Florida
Total Parenteral Nutrition-induced Cholestasis, Cholestasis
Compassionate Use of Omegaven in Children
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
- Conditions
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis
- Trial name
- NCT02370251
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Oklahoma
Adiposity, Insulin Resistance
PREterM FOrmula Or Donor Breast Milk for Premature Babies
In order to address this crucial question, central to preterm newborn care, a multicentre United Kingdom (UK) -wide study randomising 4000 preterm babies would be necessary to achieve sufficient power to evaluate the impact on…
- Conditions
- Adiposity, Insulin Resistance, Metabolomic Profile, microRNA Profile
- Trial name
- PREMFOOD (NCT01686477)
- Testing
- Unfortified Human donor Milk used to make up any shortfall in mother's own milk, Fortified Human donor Milk used to make up any shortfall in mother's own milk, Preterm Formula used when there is a shortfall in mother's own milk
- Where
- United Kingdom
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Vitamin D Deficiency, Nutritional Deficiency
Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study
The overall goal of this study is to assess maternal vitamin D status along with diet, and milk composition, and in turn, to evaluate if infant vitamin D status can be improved with increased maternal supplementation and diet…
- Trial name
- MoMO PIP (NCT04629534)
- Testing
- High dose Cholecalciferol, Cholecalciferol
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Medical University of South Carolina
Prader Willi Syndrome
Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS Infants
The Prader-Willi syndrome (PWS) includes severe neonatal hypotonia with impaired suckling leading to failure to thrive in the most severe cases, subsequently followed by an early onset of morbid obesity with hyperphagia and…
- Trial name
- OTBB2 (NCT02205034)
- Testing
- oxytocin
- Where
- France
- Volunteers
- 18 people
- Sponsor
- University Hospital, Toulouse
Infant, Newborn, Asphyxia Neonatorum
Optimising Newborn Nutrition During Therapeutic Hypothermia.
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia.
- Conditions
- Infant, Newborn, Asphyxia Neonatorum, Hypothermia, Induced, Parenteral Nutrition
- Trial name
- NCT03278847
- Testing
- Received enteral (milk) feeds during therapeutic hypothermia, Enteral (milk) feeds withheld during therapeutic hypothermia, Received parenteral nutrition during therapeutic hypothermia
- Where
- 2 sites in United Kingdom
- Volunteers
- 6,030 people
- Sponsor
- Imperial College London
Cholestasis, Jaundice, Obstructive
SMOFlipid to Lessen the Severity of Neonatal Cholestasis
Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function.
- Trial name
- NCT02721277
- Testing
- SMOFlipid
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- University of Florida
Cholestasis, Cholestasis of Parenteral Nutrition
Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
- Trial name
- NCT00738101
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 293 people
- Sponsor
- Baylor College of Medicine
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
Adolescent Mothers, Infant Obesity
Tools For Teen Moms: Reducing Infant Obesity Risk
The purpose of this social media group randomized trial (GRT) is to test the feasibility of our Baby Dayr for Teen Moms intervention to increase maternal responsiveness to infant cues and implement healthy feeding practices…
- Trial name
- TFTM (NCT02244424)
- Testing
- Tools for Teen Moms
- Where
- United States
- Volunteers
- 164 people
- Sponsor
- Michigan State University
Cystic Fibrosis, Pancreatic Cystic Fibrosis
Behavioral & Nutritional Treatment to Help CF Preschoolers Grow
The primary objective of this NIH funded clinical trial is to conduct a multi-center, randomized, controlled trial comparing two interventions: a behavioral plus nutrition intervention to a nutrition intervention.
- Trial name
- NCT00241969
- Testing
- Behavioral and Nutrition Treatment, Education and Attention Control
- Where
- 5 sites in United States
- Volunteers
- 78 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Osteoporosis, Obesity
Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!
Approximately 8 million American women suffer from osteoporosis, and one out of every two women over the age of 50 will have an osteoporotic-related fracture in their lifetime (42).
- Conditions
- Osteoporosis, Obesity, Weight Loss
- Trial name
- BEHIP (NCT00966381)
- Testing
- Exercise and weight loss intervention
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Greensboro
Hypophosphatasia (HPP)
Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP)
This clinical trial studies the safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP.
- Trial name
- NCT00744042
- Testing
- asfotase alfa
- Where
- 10 sites in United States, Canada and 2 more
- Volunteers
- 11 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
Parenteral Nutrition Associated Liver Disease
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil.
- Trial name
- NCT00862446
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Vanderbilt University Medical Center
Hypophosphatasia
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042).
- Trial name
- NCT01205152
- Testing
- asfotase alfa
- Where
- 8 sites in United States, United Arab Emirates and 1 more
- Volunteers
- 10 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Premature Infants
Clinical Experience With Numeta in Preterm Infants
The aim of this prospective noninterventional study is to evaluate the clinical application of Numeta® in preterm infants and critically ill neonates in comparison to individualized prescribed parenteral nutrition.
- Trial name
- Numeta (NCT01981057)
- Testing
- Numeta, Individual
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Medical University of Vienna
Vitamin D Deficiency
Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels…
- Trial name
- PA 03-103 (NCT00610688)
- Testing
- Prenatal Vitamin, Cholecalciferol (Vitamin D3)
- Where
- 2 sites in United States, United Arab Emirates
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati