Clinical trials: Infant
Gastroesophageal Reflux
A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
The purpose of this study is to compare the efficacy and tolerability of cisapride with placebo in infants and children with gastro-oesophageal reflux disease (GORD).
- Trial name
- NCT01281553
- Testing
- Cisapride
- Volunteers
- 6 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant
Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia
The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy.
- Conditions
- Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias, Metabolic Diseases
- Trial name
- RADICHOL 1 (NCT00607373)
- Testing
- mipomersen
- Where
- 10 sites in United States, Brazil and 5 more
- Volunteers
- 51 people
- Sponsor
- Kastle Therapeutics, LLC
Rotavirus Infections
Consistency Lots Vaccine Study (V260-009)
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
- Trial name
- NCT00092456
- Testing
- rotavirus vaccine, live, oral, pentavalent
- Volunteers
- 793 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Mental Health Wellness 1, Preterm Birth
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth.
- Trial name
- MLI (NCT05012072)
- Testing
- The Mastery Lifestyle Intervention
- Where
- United States
- Volunteers
- 238 people
- Sponsor
- Microgen LLC
Growth
Preterm Infants Fed a Human Milk Fortifier
This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
- Trial name
- NCT05551975
- Testing
- Control Product, Experimental Product 1, Experimental Product 2
- Where
- 14 sites in United States
- Volunteers
- 321 people
- Sponsor
- Abbott Nutrition
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Cystic Fibrosis
To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration
This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects
- Trial name
- NCT02679729
- Testing
- AZD5634 for inhalation, AZD5634 for infusion
- Where
- 2 sites in United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Dysentery, Dysentery, Shigella
Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine
The goal of this clinical trial is to evaluate the protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine against diarrhea caused by Shigella infection in infants and children aged 6 months to 5 years.
- Trial name
- NCT06838195
- Testing
- S. Flexneri-S. Sonnei bivalent conjugate vaccine
- Where
- Bangladesh
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Infant Nutrition
Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk
A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B.
- Trial name
- NCT03204630
- Testing
- Lfer, Bifido, Control
- Where
- 2 sites in Spain
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
Bronchopulmonary Dysplasia
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
- Trial name
- NCT03857841
- Testing
- UNEX-42, Phosphate-buffered saline
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- United Therapeutics
Feeding Intolerance
Feeding Intolerance in Formula-Fed Infants
This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.
- Trial name
- NCT02028156
- Testing
- Partially Hydrolyzed Infant Formula
- Where
- 3 sites in China
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Cystic Fibrosis
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation
The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of ivacaftor and metabolites in participants with cystic fibrosis (CF) who are <24 months of age at treatment initiation and have an…
- Trial name
- NCT02725567
- Testing
- IVA
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 57 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Non-invasive Ventilatory Support, Infant Respiratory Distress Syndrome
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
The purpose of this observational study is to collect data on vital signs, oxygen requirements and other data related to ventilator care in preterm neonates under standard of care treatment.
- Trial name
- NCT01861795
- Testing
- Preterm Neonates
- Where
- 3 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Takeda
Rotavirus Gastroenteritis
To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus
Study Rationale A single Rotavirus vaccine container with the vaccine virus and antacid buffer would be ideal for logistical, administrative and distribution ease, especially in routine immunization program.
- Trial name
- ROTAVAC5C (NCT04819412)
- Testing
- ROTAVAC®, ROTAVAC 5C -F1, ROTAVAC 5C -F2
- Volunteers
- 1,975 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Hepatitis B
Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course…
- Trial name
- NCT00880477
- Testing
- DTPa-HBV-IPV/Hib vaccine, DTPa-IPV/Hib vaccine, EngerixTM-B
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis
The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis (CF). It will also learn if the drug works to treat works to treat CF with a specific mutation (3849 +10kb C-->T).
- Trial name
- NCT06429176
- Testing
- SPL84
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- SpliSense Ltd.
Acellular Pertussis, Diphtheria
Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
- Conditions
- Acellular Pertussis, Diphtheria, Tetanus, Poliomyelitis
- Trial name
- NCT01568060
- Testing
- Infanrix-IPV data collection
- Where
- South Korea
- Volunteers
- 645 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus (RSV), Lower Resp Tract Infection
A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections.
- Trial name
- REVIRAL 1 (NCT04225897)
- Testing
- RV521
- Where
- 60 sites in Argentina, Canada and 13 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Achondroplasia
A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia
Study 111-206 is a Phase 2 randomized, double-blind, placebo-controlled clinical trial of BMN 111 in infants and young children with a diagnosis of achondroplasia.
- Trial name
- NCT03583697
- Testing
- BMN 111
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 75 people
- Sponsor
- BioMarin Pharmaceutical
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.