Clinical trials: Term Infants
Cystic Fibrosis
A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation
To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI), in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance regulator (CFTR) gating mutation
- Trial name
- NCT02742519
- Testing
- ivacaftor
- Where
- 6 sites in Australia, Canada and 1 more
- Volunteers
- 14 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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
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
Health Behavior, Personal Satisfaction
Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China
The purpose of this study is to determine the effect of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed…
- Trial name
- NCT01373541
- Testing
- InFat™ based infant formula, Standard vegetable oil based infant formula
- Where
- China
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Nutritional and Metabolic Diseases
Efficacy and Safety of Stannsoporfin in Neonates
This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the…
- Trial name
- NCT02685137
- Testing
- stannsoporfin
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
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.
Meconium Aspiration
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
- Trial name
- NCT00004500
- Testing
- Lucinactant, Standard Care
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Windtree Therapeutics
Nosocomial Infections
Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.
- Trial name
- NCT00854633
- Testing
- Talactoferrin
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Agennix
Hunter Syndrome, Mucopolysaccharidosis II (MPS II)
Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year Phase 2/Phase 3 registration study.
- Trial name
- NCT00630747
- Testing
- Idursulfase
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 94 people
- Sponsor
- Shire
Growth
Study of Nutritional Suitability of a New Infant Formula for Term Infants
This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.
- Trial name
- NCT02490852
- Testing
- Investigational infant formula, Active Comparator: Commercially available Infant formula, Active Comparator: Human milk
- Where
- 18 sites in Austria, Croatia and 2 more
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Ausnutria Hyproca B.V.
Child Development
The Effect of a New Infant Formula on Growth and Cognition in Healthy Term Infants
This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the nutritive effects of two staged study formulas on growth and cognitive outcomes.
- Trial name
- NCT04508257
- Testing
- Oral feeding of Investigational Formula (Stage 1&2), Oral feeding of Control formula (Stage 1&2), Breast feeding
- Where
- 3 sites in China
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Malaria
An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa
The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following…
- Trial name
- NCT02207816
- Testing
- Blood sampling, Malaria Vaccine 257049 (MALARIA-055 PRI), Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
- Where
- 3 sites in Burkina Faso, Kenya and 1 more
- Volunteers
- 3,084 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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, 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
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 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
Infant Development
Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas
A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.
- Trial name
- NCT05947084
- Testing
- Infant Formula
- Where
- 29 sites in United States
- Volunteers
- 518 people, healthy volunteers welcome
- Sponsor
- Aussie Bubs, Inc.
Infections, Rotavirus
To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants
This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the…
- Trial name
- NCT00420745
- Testing
- Rotarix™
- Where
- 31 sites in France, Poland and 2 more
- Volunteers
- 1,009 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination
This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three…
- Trial name
- NCT00984139
- Testing
- Engerix™-B Kinder
- Where
- 24 sites in Germany
- Volunteers
- 306 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del…
- Trial name
- NCT03525574
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 110 sites in United States, Australia and 11 more
- Volunteers
- 507 people
- Sponsor
- Vertex Pharmaceuticals Incorporated