Clinical trials: Healthy Term Infants
Healthy Infants
Characterization of the Gastrointestinal Microbiota in Newborn Infants
The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1).
- Trial name
- BABIES I (NCT06789484)
- Testing
- Probiotic
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hvidovre University Hospital
Healthy
The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants
This is a randomized, open-label, prospective study to evaluate the nutritive effects of an a2 infant formula on growth and tolerance in healthy term infants.
- Trial name
- NCT06256094
- Testing
- a2 Platinum Premium Infant Formula Stage 1, Frisolac Infant Formula Stage 1 (Dutch Edition)
- Where
- China
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
Bottle Feeding
Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants
The primary objective of the study was to compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of infants randomized to receive either standard formula, or 1…
- Trial name
- 9055A1-2000 (NCT02031003)
- Testing
- Infant formula
- Where
- 4 sites in Taiwan
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy Infants
The Trial of a New Infant Formula in Healthy Term Chinese Infants
The aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides.
- Trial name
- HexaHMO (NCT06053112)
- Testing
- New infant formula with 6 HMOs blend, Standard infant formula without 6 HMOs blend
- Where
- 5 sites in China
- Volunteers
- 326 people, healthy volunteers welcome
- Sponsor
- Junlebao Dairy Group Co., Ltd.
Healthy Term Infants Solely Formula Fed
Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator. Hypothesize there will be no difference between formula groups.
- Trial name
- NCT00666120
- Testing
- Enfamil LIPIL with iron, Good Start Supreme with DHA and ARA
- Where
- 18 sites in United States
- Volunteers
- 333 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Infant, Newborn, Jaundice
Prediction of Jaundice in Term Infants
The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.
- Trial name
- NCT01203410
- Where
- 13 sites in United States
- Volunteers
- 535 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Tolerance
Healthy Term Infants Fed Milk-Based Infant Formula
This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.
- Trial name
- NCT04529759
- Testing
- Control Infant Formula, Experimental Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Infant Formula Intolerance
The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants
Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin.
- Trial name
- NCT02363582
- Testing
- formula
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Healthy
Probiotic Formula and Infant Growth
This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life.
- Trial name
- NCT01476397
- Testing
- Control infant formula, Test infant formula
- Where
- 8 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infant Nutritional Physiological Phenomena, Infant Formula
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
- Conditions
- Infant Nutritional Physiological Phenomena, Infant Formula, Infant Health, Infant Development
- Trial name
- NCT05868408
- Testing
- Control Formula, Experimental Formula 1, Experimental Formula 2
- Where
- 5 sites in Philippines, Saudi Arabia
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Hydration
ROSA Oligomineral Water for Oral Hydration in 6-Month-Old Healthy Infants
The present study evaluates the safety of ROSA oligomineral water in 6-to-12-month old healthy children.
- Trial name
- ROSAH (NCT04012372)
- Testing
- ROSA Water, Control water
- Where
- Serbia
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
Healthy
New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety
This study is initiated to investigate the effect of a new infant formula in healthy term subjects on growth, body composition, tolerance and safety.
- Trial name
- Venus (NCT01609634)
- Testing
- Test Product, Control Product 1, Control Product 2
- Where
- 2 sites in Singapore
- Volunteers
- 541 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Infant, Newborn
Tolerance of Healthy Term Infants Fed Infant Formulas
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
- Trial name
- NCT00705562
- Testing
- milk protein formulas, varying carbohydrate/protein sources
- Where
- 15 sites in United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Diarrhea, Atopic Dermatitis
Cesarean Section Study
Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section.
- Trial name
- NCT01992497
- Testing
- Probiotic
- Where
- Germany
- Volunteers
- 721 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and…
- Trial name
- MELODY (NCT03979313)
- Testing
- MEDI8897
- Where
- 198 sites in United States, Argentina and 29 more
- Volunteers
- 3,012 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Brain Structure and Development in Pre-Term and Full-Term Infants
The purpose of this study is to see how full-term and pre-term infants' brains relate to their movement and development throughout the first two years of life.
- Trial name
- NCT00679471
- Where
- 2 sites in United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Infant, Newborn
Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.
- Trial name
- NCT00798382
- Testing
- soy protein formula, Commercially available soy formula, Soy formula experimental #2
- Where
- 17 sites in United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Healthy Growth
Growth and Safety Clinical Trial on a New Infant Formula.
The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.
- Trial name
- NCT04671576
- Testing
- Control Infant Formula, Organic Infant Formula
- Where
- United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Nara Organics
Healthy Term Infants
Randomised, Controlled Study to Assess Safety and Tolerance of Infant Formula With Prebiotics and Postbiotics in Healthy Infants.
A randomised, controlled, double-blind, parallel group, multi-country study to investigate the safety and tolerance of infant formula with prebiotics and postbiotics in healthy term infants.
- Trial name
- WAVE (NCT04015050)
- Testing
- milk based infant formula
- Where
- Poland
- Volunteers
- 279 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Cerebral Palsy, Infant Development
Relationship Between Prenatal Maternal Distress and the Quality of General Movements at 3 Months
Depression and anxiety symptoms are common during pregnancy which may disturb the intrauterine environment by affecting the mother's physiological responses to stress, and ultimately impair fetal and postnatal development.
- Conditions
- Cerebral Palsy, Infant Development, Maternal Distress
- Trial name
- NCT05694676
- Testing
- Assessment of the quality of Genaral Movements (GMs), State-Trait Anxiety Inventory-Trait, (STAI-T), Beck Depression Inventory, (BDI)
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Karamanoğlu Mehmetbey University