Clinical trials: Infant Nutrition
Parenteral Nutrition-Associated Liver Disease
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
- Trial name
- NCT01050660
- Testing
- Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Yale University
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
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.
Obesity, Obesity, Childhood
In-home Obesity Prevention to Reach Low-income Infants
Existing obesity prevention efforts have had limited success among underserved, low-income children. This study capitalizes on the strengths of a nationwide ongoing Home Visitation Program (HVP), which serves at-risk, low-income…
- Conditions
- Obesity, Obesity, Childhood, Obesity; Familial
- Trial name
- NCT03529695
- Testing
- Standard HVP Curriculum, Obesity Prevention
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Cystic Fibrosis Related Diabetes, Pancreatic Insufficiency
Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the…
- Trial name
- NCT00763412
- Testing
- repaglinide
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Arbelaez, Ana Maria
Cholestasis
Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders
Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC).
- Trial name
- NCT01373918
- Testing
- Intralipid
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- University of California, Los Angeles
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
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 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 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
Breast Feeding, Infant Nutrition
Feeding My Baby - A National WIC Study
The goal of the study is to be a current examination of infant and toddler feeding practices among families receiving WIC services.
- Conditions
- Breast Feeding, Infant Nutrition, Childhood Obesity, Infant Feeding Patterns
- Trial name
- NCT02031978
- Volunteers
- 4,367 people
- Sponsor
- USDA Food and Nutrition Service
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
Hypophosphatasia
Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)
This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone.
- Trial name
- NCT01176266
- Testing
- asfotase alfa
- Where
- 23 sites in United States, Australia and 10 more
- Volunteers
- 69 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Focus: Nutritional Requirements for Infants
Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses.
- Trial name
- NCT02092857
- Testing
- Arachidonic acid (25 mg/100 kcal ), Arachidonic acid (34 mg/100 kcal)
- Where
- Canada
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- University of Alberta
Pediatric Obesity
Healthy Eating for My Infant (HEMI)
Infants from underserved and minority backgrounds are at increased risk for obesity and poor feeding and nutrition outcomes, but obesity prevention programs tailored specifically to the needs of these infants are lacking.
- Trial name
- NCT04977947
- Testing
- Healthy Eating for My Infant
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati
Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment…
- Trial name
- NCT02579265
- Testing
- Smoflipid 20% (investigational lipid for parenteral nutrition), Intralipid® 20%
- Where
- 13 sites in United States
- Volunteers
- 204 people
- Sponsor
- Fresenius Kabi
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
Infant,Premature, Body Weight
Serial Assessment of Body Fat Accrual in Very Preterm Infants
Despite evidence that both rapid weight gain and excessive body fat accrual are associated with overweight and obesity, usual neonatal care of preterm infants does not include assessment of body fat accrual.
- Conditions
- Infant,Premature, Body Weight, Adiposity
- Trial name
- NCT03575897
- Testing
- Assessment of infant body composition
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Alabama at Birmingham
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.
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