Clinical trials: Infant Term Birth
Health Behavior, Disorder of Growth and Development
The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters in Infants (InFat_005)
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters in term formula fed infants.
- Trial name
- NCT01116115
- Testing
- InFat™ based infant formula, Standard vegetable oil based infant formula
- Where
- Israel
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Enzymotec
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.
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
Infant Development
Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants
A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the…
- Trial name
- NCT04593147
- Testing
- BBN, Brand
- Where
- United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Building Block Nutritionals, LLC
Gastrointestinal Tolerance
Tolerance of Healthy Term Infants Fed Infant Formulas #3
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.
- Trial name
- NCT00977964
- Testing
- Experimental milk protein infant formula Process A, Experimental milk protein infant formula Process B, Experimental milk protein infant formula Process C
- Where
- 15 sites in United States
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
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
Growth, Infections
Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and…
- Trial name
- NCT06137235
- Testing
- cows milk infant formula and follow-on formula with bioactive ingredients, standard cows milk infant formula and follow-on formula
- Where
- 3 sites in Greece
- Volunteers
- 456 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina
Hunter Syndrome
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV)…
- Trial name
- NCT01506141
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Takeda
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
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
Cystic Fibrosis
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
- Trial name
- NCT06460506
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 18 sites in Australia, Canada and 5 more
- Volunteers
- 50 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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
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
Innate Immunity
Immunity Modification of Full Term Infants According to the Type of Feeding and Mode of Delivery
This is a single-center, double-blind, randomized controlled trial, with parallel groups and reference group. The aim of the study was to investigate the immunity of infant born from caesarian section and fed with formula milk…
- Trial name
- NCT04256356
- Testing
- Feeding infants with formula milk with fermented matrix at dosage of 4.6 g per 100g of powder, Feeding infants with formula milk with fermented matrix at dosage of 6.9 g per 100g of powder, Feeding infants with standard formula milk
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Heinz Italia SpA
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen
Heart Defects, Congenital
Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation
This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.
- Trial name
- CLARINET LT (NCT00833703)
- Testing
- Clopidogrel
- Where
- 15 sites in United States, Brazil and 13 more
- Volunteers
- 49 people
- Sponsor
- Sanofi
Pneumococcal Conjugate Vaccine
Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort
The purpose of this study is to assess the "late" immune response to further doses of pneumococcal conjugate vaccine more than 10 years after primary immunization with Prevnar (7vPnC) in infancy, as compared with individuals who…
- Trial name
- PILOT (NCT00824850)
- Testing
- 13-valent Pneumococcal Conjugate Vaccine
- Where
- 2 sites in United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Pfizer
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.
Cystic Fibrosis
Rollover Study of VX-770 in Cystic Fibrosis Subjects
The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF).
- Trial name
- NCT01117012
- Testing
- Ivacaftor
- Where
- 58 sites in United States, Australia and 6 more
- Volunteers
- 192 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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