Clinical trials: Term Infant
Term Infants
The Evaluation of Cow Milk-Based Formulas
Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.
- Trial name
- NCT00518414
- Testing
- Marketed infant formula with DHA and ARA, Milk-based infant formula with DHA and ARA, Milk-based formula with DHA, ARA, prebiotics
- Where
- 9 sites in United States
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Child Development
Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compared with a concurrent control…
- Trial name
- NCT04013087
- Testing
- Oral feeding of Feihe Stage 1 infant formula, Oral feeding of control Stage 1 formula, Breast feeding
- Where
- 3 sites in China
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Healthy Infants
To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants
This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants. Screening starts after the informed consent is obtained.
- Trial name
- NCT03520764
- Testing
- New infant formula with synbiotics, Standard infant formula with prebiotics
- Where
- 6 sites in China
- Volunteers
- 284 people, healthy volunteers welcome
- Sponsor
- Danone Nutricia
Cystic Fibrosis
Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation
The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).
- Trial name
- KONTINUE (NCT01707290)
- Testing
- Ivacaftor
- Where
- 38 sites in United States, Belgium and 2 more
- Volunteers
- 125 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Atopic Diseases
Prevention of Allergic Diseases in Infants
A multi-center, prospective, randomized, controlled, doubleblind intervention clinical Trial is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of developing an allergy.
- Trial name
- NCT03489733
- Testing
- Hydrolyzed Formula, Control formula
- Where
- 14 sites in Bulgaria, Czechia and 8 more
- Volunteers
- 1,226 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Dermatitis, Atopic, Eczema, Infantile
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.
- Conditions
- Dermatitis, Atopic, Eczema, Infantile, Infant Development, Child Development
- Trial name
- GIraFFE (NCT04599946)
- Testing
- Infant formula and follow-on formula made from whole goat milk, Infant formula and follow-on formula made from cow's milk ingredients
- Where
- 12 sites in Germany, Poland and 1 more
- Volunteers
- 2,132 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited
Cystic Fibrosis
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
- Trial name
- NCT04362761
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 29 sites in Australia, Belgium and 2 more
- Volunteers
- 172 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy Term Infants
The Evaluation of Cow's Milk Formula - Study B
A study to evaluate the growth and development of term infants fed either a marketed cow's milk formula, or an experimental cow's milk formula with prebiotics + a different calcium source + a different level of fatty acids and…
- Trial name
- NCT00712608
- Testing
- Infant formula, Cow's milk infant formula
- Where
- 22 sites in United States
- Volunteers
- 399 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Infant Term Birth
Happy Smooth Study
The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.
- Trial name
- NCT03710551
- Testing
- Experimental Infant Formula, Standard Infant Formula
- Where
- Philippines
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Magnetic Resonance Imaging
Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)
The main purpose of this study is to collect data on the way gadobutrol is taken into, moves around, and is eliminated from, the body of children aged 0 to less than 2 years.
- Trial name
- NCT01544166
- Testing
- Gadobutrol (Gadavist, BAY86-4875)
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 44 people
- Sponsor
- Bayer
Infant Term Birth
Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.
- Trial name
- NCT02598817
- Testing
- Standard Infant Formula
- Where
- 5 sites in Saudi Arabia, United Arab Emirates
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infant Development
Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants
The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth.
- Trial name
- NCT04749290
- Testing
- Study Formula
- Where
- 2 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Bunge Loders Croklaan
Healthy Term Infants
Tolerance of Healthy Term Infants Fed Infant Formulas #4
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.
- Trial name
- NCT01155414
- Testing
- Hydrolysate based infant formula, Investigational Infant Formula A, Investigational Infant Formula B
- Where
- 10 sites in United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Cystic Fibrosis
A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation
This is a Phase 3, multicenter, open-label, 3-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in studies VX13-661-103 (Study 103, NCT02070744)…
- Trial name
- NCT02565914
- Testing
- TEZ/IVA, IVA
- Where
- 154 sites in United States, Australia and 14 more
- Volunteers
- 1,131 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Growth
Safety of an Infant Formula With Hydrolysed Protein in Term Infants
A multi-centre, randomised, double-blind, parallel-group, controlled, prospective, non-inferiority intervention clinical trial is performed to assess the safety and suitability of an infant formula manufactured from extensively…
- Trial name
- HASI (NCT04736082)
- Testing
- Intervention Group: Infant Formula with hydrolyzed protein, Control Group: Infant Formula with intact protein
- Where
- Germany
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Neonates
NICU-TECH RM9L-RS Probe ME Feasibility Study
Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself.
- Trial name
- NCT01181596
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- GE Healthcare
Healthy
Evaluation of Mineral Absorption in Infants Fed Infant Formula
The purpose of this study is to measure calcium absorption in infants fed formula with and without prebiotics.
- Trial name
- NCT00366873
- Testing
- Calcium absorption
- Where
- 5 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Cystic Fibrosis
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
- Trial name
- NCT05444257
- Testing
- VX-121/TEZ/D-IVA
- Where
- 195 sites in United States, Australia and 21 more
- Volunteers
- 822 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Growth
Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term
The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.
- Trial name
- NCT00936637
- Testing
- Extensively hydrolyzed infant formula
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Perrigo Nutritionals
Cystic Fibrosis
A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
This is a double-blind randomised controlled crossover study to investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in patients admitted to hospital with infective…
- Trial name
- NCT01923753
- Testing
- Aerosure at 15 Hz, Aerosure at 25 Hz
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Actegy Ltd.