Clinical trials: Term Infant
Healthy Term Infants
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
The goal of this interventional clinical trial is to compare the growth parameters of healthy term infants fed either a new experimental rice hydrolyzed rice protein-based formula or a control formula (standard cow's milk…
- Trial name
- RIGA (NCT07686224)
- Testing
- Rice formula (New formula based on hydrolysed rice proteins), Control formula (Standard cow's milk proteins-based formula)
- Where
- 10 sites in France
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Health and Happiness Research Limited
Respiratory Distress Syndrome, Pre-term Infants
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham).
- Trial name
- NCT06776783
- Testing
- APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system), Control
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 520 people
- Sponsor
- Aerogen Pharma Limited
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
Pre-term Infant
Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants
This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without…
- Trial name
- NCT04639518
- Testing
- Preterm formulas with HMO, Preterm formulas without HMO
- Where
- 4 sites in Germany, Poland and 1 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy Term Infants
Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life
Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life
- Trial name
- NCT02646969
- Testing
- Formula regimen 1, Formula regimen 2
- Where
- 9 sites in France
- Volunteers
- 691 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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)
Healthy Term Infants
The Combiotic-Study
The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in…
- Trial name
- GOLFIII (NCT02221687)
- Testing
- Synbiotic formula, Control formula
- Where
- 25 sites in France
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
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
Infant Term Birth
Safety and Efficacy Study
The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.
- Trial name
- NCT02670863
- Testing
- Experimental Infant Formula, Standard Infant Formula
- Where
- Philippines
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy, Term Infants
Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula.
- Trial name
- NCT04389606
- Testing
- Study Formula (SF), Comparator Formula (CF)
- Where
- 27 sites in United States
- Volunteers
- 311 people, healthy volunteers welcome
- Sponsor
- ByHeart
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)
Infant Term Birth
Breastfeeding Study
The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants.
- Trial name
- NCT03387124
- Testing
- Breastfed infants
- Where
- Philippines
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy, Full-term Infants Who Are Formula-fed
Gastrointestinal Tolerance Evaluation of an Infant Formula
Prospective, double-blind, randomized study of 2 infant formulas.
- Trial name
- NCT03307122
- Testing
- Routine Infant Formula 1, Routine Infant Formula 2
- Where
- 8 sites in United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
Growth of Term Infants
The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants
This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.
- Trial name
- NCT01897922
- Testing
- An investigational infant formula containing a probiotic source, Control: Marketed routine infant formula
- Where
- 22 sites in United States
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Growth of Term Infants
The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants
This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant…
- Trial name
- NCT02132663
- Testing
- Control: Marketed routine infant formula, An investigational infant formula containing an alternate source of DHA
- Where
- 22 sites in United States
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Pre-term Infants
Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital
The purpose of this study is to assess overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization.
- Trial name
- NCT01766011
- Testing
- study pre-term formula
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- Abbott Nutrition
Formula Feeding of Healthy Full Term Infants
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune…
- Trial name
- NCT01197365
- Testing
- Infant formula with GOS, beta-palmitate, acidified milk, Standard infant formula without functional ingredients
- Where
- Italy
- Volunteers
- 148 people
- Sponsor
- Heinz Italia SpA
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
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)