Clinical trials: Infant
Infant Growth
Evaluation of Human Milk Fortifiers in Preterm Infants
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.
- Trial name
- NCT02307760
- Testing
- Human Milk Fortifier A, Human Milk Fortifier B
- Where
- 18 sites in United States
- Volunteers
- 164 people
- Sponsor
- Abbott Nutrition
Healthy
Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants
This will be a prospective observational study aiming to investigate immune health biomarkers and fecal microbiota in 48-60 Filipino breastfed infants from birth to 12 months of age.
- Trial name
- NCT06708559
- Testing
- Breast-fed infants
- Where
- Philippines
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Allergy;Food
A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula
Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by…
- Trial name
- CHARM (NCT04519827)
- Testing
- New Rice-based hydrolysate, Amino Acid-based infant formula
- Where
- 4 sites in Italy, Spain
- Volunteers
- 39 people
- Sponsor
- Dr. Schär AG / SPA
Diphtheria, Tetanus
Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)
The purpose of this study is to evaluate the safety, tolerability, and immune response of an investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis, tetanus, hepatitis B, poliomyelitis, and…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00092469
- Testing
- V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pneumococcal Infections
A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria
A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae.
- Trial name
- 6114A1-4000-CN (NCT01193582)
- Testing
- Prevenar
- Where
- 5 sites in China
- Volunteers
- 505 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Infections, Rotavirus
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
- Trial name
- NCT00938327
- Testing
- Rotarix™
- Where
- 12 sites in India
- Volunteers
- 332 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation…
- Trial name
- TRAFFIC (NCT01807923)
- Testing
- Lumacaftor Plus Ivacaftor Combination, Ivacaftor
- Where
- 89 sites in United States, Australia and 9 more
- Volunteers
- 559 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Iron Deficiency, Anaemia
Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia
An Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Ferric Carboxymaltose (FCM) in Infants (0-1 year) with Iron Deficiency Anemia.
- Trial name
- NCT04968379
- Testing
- Ferric carboxymaltose
- Where
- 4 sites in United States
- Sponsor
- American Regent, Inc.
Cystic Fibrosis
Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis
The purpose of this research study is to evaluate the safety, tolerability, and efficacy of Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period of 4 weeks to patients with mild-to-moderate…
- Trial name
- NCT00043342
- Testing
- interferon gamma-1b
- Volunteers
- 51 people
- Sponsor
- InterMune
Cystic Fibrosis, Pancreatic Insufficiency
Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis
The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations) in children and adults with cystic fibrosis…
- Trial name
- NCT00432861
- Testing
- PANCRECARB® (pancrelipase)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Digestive Care, Inc.
Healthy
Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition
A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as reference from birth to 1 year of age and a…
- Trial name
- NCT02282488
- Testing
- Low protein formula, High protein formula
- Where
- France
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Cystic Fibrosis
Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in…
- Trial name
- NCT00800579
- Testing
- GS-9411
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Growth of Infants
Addition to Infant Formula of 2-fucosyllactose (2-FL)
OBJECTIVES: Primary: The primary objective is to determine whether the mean weight gain over a 16-week interval starting on or before 14 days of life differs between infants fed one of two infant formulas as their sole source of…
- Trial name
- 2-FL (NCT03109223)
- Testing
- sole source nutrition
- Where
- 6 sites in United States, Honduras
- Volunteers
- 221 people, healthy volunteers welcome
- Sponsor
- PBM Nutritionals
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency…
- Trial name
- NCT01327703
- Testing
- Panzytrat® 25,000, Kreon® 25,000
- Where
- 13 sites in Germany, Poland
- Volunteers
- 87 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis
Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation
This is a Phase 3, multicenter, open-label and roll-over study in participants who are 12 to <24 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.
- Trial name
- NCT04235140
- Testing
- LUM/IVA
- Where
- 23 sites in United States, Canada
- Volunteers
- 52 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Phase 1, QT/QTC Interval Study in Healthy Subjects
This study is designed to evaluate the effect of multiple doses of lumacaftor in combination with ivacaftor on cardiac repolarization, as detected by QT/QTc interval corrected for heart rate in healthy subjects.
- Trial name
- NCT01910415
- Testing
- Lumacaftor, Ivacaftor, moxifloxacin hydrochloride
- Where
- Netherlands
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR function and inflammation in adult cystic…
- Trial name
- SNO-1 (NCT01746784)
- Testing
- N6022, Normal saline
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- Nivalis Therapeutics, Inc.
Nutritional Safety
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS)
The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with a "prebiotic" component (GOS) in improving the gut microflora balance, mimicking that of breast-fed infants.
- Trial name
- NCT00486148
- Testing
- Infant formula (with GOS)
- Where
- 7 sites in Italy
- Volunteers
- 360 people
- Sponsor
- Heinz Italia SpA
Bronchopulmonary Dysplasia
Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
This is a randomized, parallel-group, double-blind, placebo-controlled multicenter phase 2b/3 study with an adaptive seamless design.
- Trial name
- ZELA (NCT06897839)
- Testing
- Zelpultide alfa
- Where
- 49 sites in Argentina, Belgium and 6 more
- Volunteers
- 366 people
- Sponsor
- Airway Therapeutics, Inc.