Clinical trials: Infant
Premature Infant, Low Birthweight Infant
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)
The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth…
- Trial name
- NCT06212427
- Testing
- HMO supplement
- Where
- 6 sites in Austria, Germany
- Volunteers
- 188 people
- Sponsor
- Société des Produits Nestlé (SPN)
Lactating Women, Breastfed Infants
A Lactation Study in Women Receiving Treatment With Ozanimod
The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.
- Trial name
- NCT06181630
- Testing
- Breast milk, plasma, and blood samples
- Where
- United States
- Sponsor
- Bristol-Myers Squibb
Healthy Infants
Efficacy of Two HMOs in Chinese Infants
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier…
- Trial name
- NCT06361719
- Testing
- Experimental Group (EG), Control Group (CG)
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Respiratory Distress Syndrome in Premature Infant
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.
- Trial name
- NCT03969992
- Testing
- AeroFact, nCPAP
- Where
- 41 sites in United States, Canada
- Volunteers
- 261 people
- Sponsor
- Aerogen Pharma Limited
Mucopolysaccharidosis II
A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
This is a multicenter, multiregional, open-label study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme…
- Trial name
- NCT04251026
- Testing
- tividenofusp alfa
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 47 people
- Sponsor
- Denali Therapeutics Inc.
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
RDS of Prematurity, Preterm Birth
Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT07060911
- Testing
- Lung monitoring with the Neola device
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Neola Medical Inc
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.
Fussy Infant (Baby)
Acceptance of a Partially Hydrolyzed Formula
A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein infant formula on infant fussiness.
- Trial name
- NCT05245422
- Testing
- Infant Formula - Partially hydrolyzed protein, Infant Formula - Intact protein
- Where
- 11 sites in United States
- Volunteers
- 148 people
- Sponsor
- Mead Johnson Nutrition
Infant Development
Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
An observational study to generate a long-term outcome database from medical records for infants who completed protocol SS-101-18 or infants who are breastfed, fed commercial formula, or fed a marketed ByHeart formula.
- Trial name
- NCT05049655
- Where
- 9 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- ByHeart
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)
Malnutrition, Infant, Enteral Feeding Intolerance
Efficacy and Safety of Numeta G13%E Compared to Compounded Parenteral Nutrition in Preterm Neonates
Preterm (PT, born before 37 weeks of gestation) birth complications are the leading causes of death among children aged under 5 years globally, with nearly one million infant deaths reported in 2013.
- Trial name
- NCT06894446
- Testing
- Numeta G13%E, Compounded Parenteral Nutrition (cPN) solution
- Volunteers
- healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation
Mastitis, Breast Milk
Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis
The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis.
- Conditions
- Mastitis, Breast Milk, Lactation, Women's Health
- Trial name
- NCT04032899
- Testing
- Lactobacillus fermentum CECT5716, Maltodextrin
- Where
- 3 sites in Spain
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
Mucopolysaccharidosis Type II (MPS II)
CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome)
RGX-121 is a gene therapy which is intended to deliver a functional copy of the iduronate-2-sulfatase gene (IDS) to the central nervous system.
- Trial name
- NCT03566043
- Testing
- RGX-121
- Where
- 5 sites in United States, Brazil
- Volunteers
- 48 people
- Sponsor
- REGENXBIO Inc.
Mucopolysaccharidosis Type II (MPS II)
RGX-121 Gene Therapy in Children 5 Years of Age and Over With MPS II (Hunter Syndrome)
RGX-121 is a gene therapy which is designed to deliver a functional copy of the iduronate-2-sulfatase (IDS) gene to the central nervous system.
- Trial name
- NCT04571970
- Testing
- RGX-121
- Where
- 2 sites in United States, Canada
- Volunteers
- 6 people
- Sponsor
- REGENXBIO Inc.
Stool Assessment, Skin Rash
GI Symptoms in Infants Fed Goat Milk-based Infant Formula
A cross-sectional observational survey was conducted in Brazil, Mexico, Russia, and The Netherlands by recruiting parents/legal guardians through social media.
- Conditions
- Stool Assessment, Skin Rash, Urticaria, Regurgitation
- Trial name
- NCT06755424
- Where
- Netherlands
- Volunteers
- 425 people, healthy volunteers welcome
- Sponsor
- Ausnutria Hyproca B.V.
Identification of Infants at Risk for Type 1 Diabetes
Freder1k-Study - Testing Infants for Type 1 Diabetes Risk
The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.
- Trial name
- NCT03316261
- Where
- Germany
- Volunteers
- 1,000,000 people, healthy volunteers welcome
- Sponsor
- Helmholtz Zentrum München
Healthy Infants
Comparative Effects of A2 Platinum Stage 1 Infant Formula on Infant Digestion and Comfort
This trial is a single-blind, randomized, controlled, parallel-designed trial to compare the effects of a2 Platinum® stage 1 infant formula versus conventional, A1 and A2 β-casein-containing stage 1 infant formula versus…
- Trial name
- NCT04733937
- Testing
- a2 Platinum® stage 1 infant formula, Conventional, A1 and A2 β-casein containing stage 1 infant formula
- Where
- 5 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
Infant Development
Acceptability and Tolerance Study of an Amino Acid Formula with HMOs
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a hypoallergenic amino acid infant formula with HMOs for the dietary management of cows' milk allergy in infants less than 12 months of age.
- Trial name
- NCT04575298
- Testing
- Acceptability, tolerance study for an infant formula with human milk oligosaccharides
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Société des Produits Nestlé (SPN)
Gastrointestinal Disorder, Functional, Regurgitation, Gastric
Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study
To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from…
- Conditions
- Gastrointestinal Disorder, Functional, Regurgitation, Gastric, Colic, Infantile, Constipation - Functional
- Trial name
- TIGER (NCT05363553)
- Testing
- Infant formula based on whole goat milk, infant formula based on cow milk proteins
- Where
- Thailand
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited