Clinical trials: Infant
Cystic Fibrosis
A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis
Cystic fibrosis is the most frequent lethal genetic disease of childhood. Causes disruption of glandular function of the pancreas, intestine, liver, lungs (causing chronic lung infection with emphysema), sweat glands and…
- Trial name
- NCT00455130
- Testing
- Inhaled mannitol
- Where
- 8 sites in Australia, New Zealand
- Sponsor
- Syntara
Infantile Spasms
An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of vigabatrin.
- Trial name
- NCT01413711
- Testing
- Vigabatrin
- Sponsor
- Lundbeck LLC
Hurler Syndrome (MPS I), Hurler-Scheie Syndrome
Phase I/II Pilot Study of Mixed Chimerism to Treat Inherited Metabolic Disorders
The goal of this research study is to establish chimerism and avoid graft-versus-host-disease (GVHD) in patients with inherited metabolic disorders.
- Conditions
- Hurler Syndrome (MPS I), Hurler-Scheie Syndrome, Hunter Syndrome (MPS II), Sanfilippo Syndrome (MPS III)
- Trial name
- NCT01372228
- Testing
- hematopoietic stem cell infusion
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Talaris Therapeutics Inc.
Pneumococcal Infectious Disease
Clinical Trial of PCV24 in Infants Aged 2-23 Months
A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months.
- Trial name
- NCT06800261
- Testing
- Sinovac PCV24, Prevnar®
- Where
- 2 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Sinovac Life Sciences Co., Ltd.
Immune Response to DTP-HB-Hib Vaccine
Study Comparing DTP-HB-Hib by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Infants
This is a study planned to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian…
- Trial name
- NCT02409095
- Testing
- DTP-HB-Hib vaccine, Disposable Syringe Jet Injector (DSJI), Needle & Syringe
- Where
- 3 sites in India
- Volunteers
- 211 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Diphtheria, Tetanus
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants
The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01177722
- Testing
- DTaP-IPV-Hep B-PRP-T Vaccine, DTaP-Hep B-IPV vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,375 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pneumococcal Disease
Disease Burden of Pneumonia, Meningitis and Bacteremia Among Children in Japan: Pneumonet Japan
Streptococcus pneumoniae is a major cause of pneumonia, among infants and children in Japan and worldwideThis study plans to investigate the rate of invasive pneumococcal disease "IPD " and the rate of hospitalizations due to…
- Trial name
- NCT00757575
- Where
- 2 sites in Japan
- Volunteers
- 28,511 people
- Sponsor
- Pfizer
Declarative Memory
The Effect of Feeding Infant Formula With Enriched Protein Fractions in the US
This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.
- Trial name
- NCT02433600
- Testing
- Cow's milk-based infant formula, Cow milk-based infant formula with enriched protein fractions
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Breast Feeding, Breast Milk Expression
A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants
This is a cohort study to understand the changes of breastmilk composition in the first six months after birth of Chinese infants.
- Trial name
- Phoenix (NCT05235412)
- Testing
- Not applicable: Observational study without any interventions.
- Where
- China
- Volunteers
- 769 people, healthy volunteers welcome
- Sponsor
- Danone Nutricia
Bacterial Infections
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.
- Trial name
- NCT02527681
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Belgium and 4 more
- Volunteers
- 15 people
- Sponsor
- Basilea Pharmaceutica
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis
This study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic response of patients with cystic fibrosis to administration of QAU145 via intranasal spray.
- Trial name
- NCT00506792
- Testing
- QAU145
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Retinopathy of Prematurity (ROP)
Rainbow Extension Study
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study…
- Trial name
- RainbowExt (NCT02640664)
- Testing
- Ranibizumab
- Where
- 73 sites in United States, Austria and 22 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
Netherton Syndrome
Natural History of Netherton Syndrome
The goal of this non-interventional study (NIS) is to collect real-world data to describe the natural history of Netherton Syndrome (NS).
- Trial name
- NCT05902663
- Where
- 4 sites in United States, Italy
- Volunteers
- 4 people
- Sponsor
- Boehringer Ingelheim
Child Development
Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compared with a concurrent control…
- Trial name
- NCT04013087
- Testing
- Oral feeding of Feihe Stage 1 infant formula, Oral feeding of control Stage 1 formula, Breast feeding
- Where
- 3 sites in China
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Infant Nutrition
Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs
The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in…
- Trial name
- NCT03513744
- Testing
- human milk oligosaccharides
- Where
- 9 sites in Germany, Italy and 1 more
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- Jennewein Biotechnologie GmbH
Pneumococcal Immunization
Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
This study is a Phase 3, randomized, modified double-blind study which aims to measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called…
- Trial name
- NCT06824181
- Testing
- PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine
- Where
- 27 sites in United States, Chile and 2 more
- Volunteers
- 580 people, healthy volunteers welcome
- Sponsor
- Sanofi
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates 2
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their…
- Trial name
- BANON2 (NCT04714775)
- Where
- 13 sites in Germany, Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- InfanDx AG
Healthy Subjects
A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone.
- Trial name
- NCT01250756
- Testing
- 7-pneumococcal conjugate vaccine (7vPnC), diphtheria, tetanus, and acellular pertussis vaccine (DTaP), DTaP
- Where
- 18 sites in Japan
- Volunteers
- 321 people, healthy volunteers welcome
- Sponsor
- Pfizer
Cystic Fibrosis
A Study to Confirm the Long-term Safety and Effectiveness of Kalydeco in Patients With Cystic Fibrosis Who Have an R117H-CFTR Mutation, Including Pediatric Patients
The purpose of this study is to confirm the long-term safety and effectiveness of Kalydeco® (ivacaftor) in US CF patients with the R117H-CFTR mutation <18 years of age and to describe the long-term safety and effectiveness of…
- Trial name
- NCT02722057
- Volunteers
- 368 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Infant Nutrition Disorders, Infant, Premature, Diseases
Safety During Use of Paediatric Triple Chamber Bag Formulas
The primary objective of this study was to provide daily information on the performance safety of the Ped3CB in practical therapeutic use in pediatric patients.
- Conditions
- Infant Nutrition Disorders, Infant, Premature, Diseases, Digestive System Disorders
- Trial name
- NCT01304394
- Testing
- Ped3CB
- Where
- 13 sites in Belgium, France
- Volunteers
- 161 people
- Sponsor
- Baxter Healthcare Corporation