Clinical trials: Term Infant
Preterm Birth, Healthy
A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age…
- Trial name
- NCT03630679
- Where
- Singapore
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
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)
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
MPS II, Hunter Syndrome (MPS II)
An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta)
The objective of this study is to assess the long-term safety and efficacy of Hunterase for approximately 1 year in subjects who completed the end of study (EOS) visit (Visit 54) tests in the Phase 3 Hunterase study and patients…
- Conditions
- MPS II, Hunter Syndrome (MPS II), Hunter Syndrome, Hunterase
- Trial name
- NCT07344376
- Testing
- Hunterase
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- GC Biopharma Corp
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
Mucopolysaccharidosis II
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
This is a multiregional open-label extension (OLE) to assess the safety, tolerability, and efficacy of long-term treatment with tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant intravenous…
- Trial name
- NCT06075537
- Testing
- tividenofusp alfa
- Where
- 30 sites in United States, Argentina and 12 more
- Volunteers
- 99 people
- Sponsor
- Denali Therapeutics Inc.
Bottle Feeding
Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants
The primary objective of the study was to compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of infants randomized to receive either standard formula, or 1…
- Trial name
- 9055A1-2000 (NCT02031003)
- Testing
- Infant formula
- Where
- 4 sites in Taiwan
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Nystagmus, Congenital, Nystagmus, Acquired
Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus
The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN).
- Conditions
- Nystagmus, Congenital, Nystagmus, Acquired, Multiple Sclerosis
- Trial name
- NCT00799942
- Testing
- Neramexane mesylate
- Where
- United Kingdom
- Volunteers
- 48 people
- Sponsor
- Merz Pharmaceuticals GmbH
13-valent Pneumococcal Vaccine, Premature Birth
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines…
- Conditions
- 13-valent Pneumococcal Vaccine, Premature Birth, Immunization, Safety
- Trial name
- NCT01193335
- Testing
- 13-valent pneumococcal conjugate vaccine
- Where
- 12 sites in Poland, Spain
- Volunteers
- 200 people
- Sponsor
- Pfizer
Lung Disease
Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies
The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy…
- Trial name
- NCT00551642
- Testing
- Nitric oxide
- Where
- 35 sites in Belgium, Finland and 7 more
- Volunteers
- 800 people
- Sponsor
- Mallinckrodt
Infant, Newborn
Tolerance of Healthy Term Infants Fed Infant Formulas
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
- Trial name
- NCT00705562
- Testing
- milk protein formulas, varying carbohydrate/protein sources
- Where
- 15 sites in United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Growth
Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term
The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.
- Trial name
- NCT00936637
- Testing
- Extensively hydrolyzed infant formula
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Perrigo Nutritionals
Small for Gestational Age (SGA) Infants, Appropriate for Gestational Age (AGA) Infants
An Observational Study to Characterize Human Milk From Mothers Delivering Term SGA and AGA Infants.
This is an observational study to characterize human milk of mothers delivering term SGA and term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6 months postpartum), 4 parallel groups, and…
- Trial name
- NCT02421445
- Where
- 3 sites in India
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Enterovirus Infections
Extension Study of Protocol EV-BR1701 Group B1
The main study was a randomized, multi-nation, multi-centered, double-blinded, phase III study on subjects aged 2 months to <6 years old (<72 months). Two parts were conducted in Taiwan (Group A) and Vietnam (Group B).
- Trial name
- NCT07630493
- Where
- Vietnam
- Volunteers
- 126 people
- Sponsor
- Enimmune Corporation
Poliomyelitis, Vaccine Reaction
Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants
Eupolio is inactivated poliovirus vaccine (IPV). Major purpose of this study is to evaluate safety of Eupolio in 2,000 infants. In addition to the safety, long-term protection after completion of the three primary vaccinations…
- Trial name
- NCT05431933
- Testing
- Eupolio
- Where
- 10 sites in Philippines, Thailand
- Volunteers
- 2,001 people, healthy volunteers welcome
- Sponsor
- LG Chem
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
Healthy Term Infants Solely Formula Fed
Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator. Hypothesize there will be no difference between formula groups.
- Trial name
- NCT00666120
- Testing
- Enfamil LIPIL with iron, Good Start Supreme with DHA and ARA
- Where
- 18 sites in United States
- Volunteers
- 333 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Gastro-Intestinal Tolerance
Formula Tolerance of Term Infants
To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants
- Trial name
- NCT04915937
- Testing
- Study Infant Formula
- Where
- 12 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Pulmonary Infections, Pseudomonas Aeruginosa in Cystic Fibrosis
Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis
This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.
- Trial name
- NCT01519661
- Testing
- TBM100
- Where
- 49 sites in United States, Argentina and 8 more
- Volunteers
- 157 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation
The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR…
- Trial name
- NCT01946412
- Testing
- Ivacaftor
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 33 people
- Sponsor
- Vertex Pharmaceuticals Incorporated