Clinical trials: Healthy Term Infants
Formula Feeding of Healthy Full Term Infants, Breast Feeding of Healthy Full Term Infants
Impact of Infant Feeding on Newborn Metabolomic Profile
The purpose of this study is the evaluation with untargeted modalities, of the urine metabolomic profile in a group of infants fed with a standard formula, a group of infants fed with a formula supplemented with functional…
- Trial name
- NCT01606683
- Testing
- Infant formula with GOS, beta-palmitate, acidified milk, Standard infant formula without functional ingredients, No intervention
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Heinz Italia SpA
Pleasant Touch, Cortical Response
GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)
This study will attempt to measure the direct effect of pleasant skin touch on the developing infant brain. The massage intervention stimulates a specific class of unmyelinated C-fibres in the skin called C-touch (CT) afferents…
- Trial name
- NCT03731195
- Where
- 2 sites in Ireland, United Kingdom
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University College Cork
Dermatitis, Allergic Contact, Infectious Diseases
Incidence of Allergic Manifestations and Infectious Episodes in Healthy Term Infants at Risk for Dysbiosis
This study will evaluate the incidence of allergic manifestations (the first of which is atopic dermatitis) and infectious diseases in children fed with an infant formula under real conditions of use.
- Trial name
- SOPRANO (NCT04182425)
- Testing
- Infant formula
- Where
- France
- Volunteers
- 334 people, healthy volunteers welcome
- Sponsor
- Bledina
Gastrointestinal Tolerance, Gastrointestinal Symptoms
Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.
- Conditions
- Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections, Quality of Life
- Trial name
- MESK-2 (NCT07342972)
- Testing
- Goat milk-based infant formula, Cow's milk-based infant formula
- Where
- Saudi Arabia
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Ausnutria Hyproca B.V.
Healthy Term Infant
The Impact of a Novel Infant Formula on Immunity, Gut Health and Growth
The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.
- Trial name
- NCT06686433
- Testing
- Novel infant formula, Standard infant formula
- Where
- 5 sites in China
- Volunteers
- 342 people, healthy volunteers welcome
- Sponsor
- Biostime (Guangzhou) Health Products Limited
RSV Immunization, Healthy Volunteer
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection…
- Trial name
- NCT05437510
- Testing
- Nirsevimab
- Where
- 240 sites in France, Germany and 1 more
- Volunteers
- 8,057 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Breastmilk Collection, Childhood Obesity
Breastmilk Composition and Microbial Profile in the Growth and Development of Healthy Term-born Infants
An increasing number of children are developing non-communicable diseases that carry immediate and long-term significant societal and economic impacts.
- Conditions
- Breastmilk Collection, Childhood Obesity, Childhood Asthma, Allergy
- Trial name
- NCT06970535
- Where
- 2 sites in Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Respiratory Syncytial Virus Infection
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants.
- Trial name
- CLEVER (NCT04767373)
- Testing
- Clesrovimab
- Where
- 217 sites in United States, Argentina and 22 more
- Volunteers
- 3,632 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Term Babies
A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula
Objectives: To evaluate the safety; efficacy; bone mineral metabolism \& immunity changes of the use of Metlin \& Metlos added to the Infant Formula Study Design: Randomized, double blind, clinical, controlled trial, in 600…
- Trial name
- NCT01251783
- Testing
- Infant Formula, Exclusively breast milk, Metlin+metlos+Lactobacillus GG
- Where
- Mexico
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- National Institute of Pediatrics, Mexico
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
Infant ALL
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
The goal of this clinical trial is to study growth (weight gain per day) in healthy full-term infants who consume the investigational infant formula containing beneficial ingredients against infants consuming a control infant…
- Trial name
- NCT07867509
- Testing
- Infant Formula, Breastfeeding
- Volunteers
- 387 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina
Healthy Full Term Infants
Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery
The primary objectives of this trial are: to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp.
- Trial name
- NCT02031887
- Testing
- formula with synbiotics, formula without synbiotics
- Where
- 3 sites in South Africa
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infants
Healthy Term Infants Fed Milk-Based Formulas
This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.
- Trial name
- NCT02069522
- Testing
- Standard Milk-based Formula Containing Carotenoid, Investigational Milk-based Formula Containing Carotenoid
- Where
- 6 sites in United States
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Diphtheria, Tetanus
Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine
A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00877357
- Testing
- Shan 5
- Where
- India
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Shantha Biotechnics Limited
Healthy Infant and Mother Pairs
Ex Vivo Exploratory Analysis in Healthy Full-term Infants
Exploratory analyses of the immune response in a ex vivo culture system Characterization of the composition of maternal milk and infant urine
- Trial name
- NCT01573884
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Healthy
Tolerance of Healthy, Term Infants to Infant Formulas
To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula
- Trial name
- NCT00543673
- Testing
- Milk based formula A, #2 Standard formula, #3 Human Milk
- Where
- 10 sites in United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
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
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 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
ABO Incompatibility, Hemolytic Disease of Newborn
Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis
The purpose of this research study is to more accurately measure the amount of true red blood cell breakdown (hemolysis) in newborn babies with potentially problematic blood type mismatch with their mothers (ABO incompatibility)…
- Conditions
- ABO Incompatibility, Hemolytic Disease of Newborn, Neonatal Jaundice, Neonatal Hyperbilirubinemia
- Trial name
- NCT00917007
- Where
- 2 sites in United States
- Sponsor
- State University of New York - Upstate Medical University