Clinical trials: Infant and Young Children
Coarctation of the Aorta, Pulmonary Artery Stenosis
Growth Trial: Study of the Renata Minima Stent
The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e.…
- Trial name
- NCT05086016
- Testing
- Catheterized Stenting
- Where
- 7 sites in United States
- Volunteers
- 42 people
- Sponsor
- Renata Medical
Asthma
Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)
Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study.
- Trial name
- NCT00943397
- Testing
- montelukast sodium, Comparator: Usual Care
- Volunteers
- 190 people
- Sponsor
- Organon and Co
Infant Growth
Growth and Health Efficacy of Novel Infant Formula : A Randomized Trial
Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.
- Trial name
- NCT07534735
- Testing
- Investigational Formula 1, Investigational Formula 2
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Biostime (Changsha) Nutrition Foods Limited
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
Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations
Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat pediatric and adult participants who have severe-to profound and profound hearing loss due to…
- Trial name
- CHORD (NCT05788536)
- Testing
- DB-OTO
- Where
- 17 sites in United States, Germany and 3 more
- Volunteers
- 36 people
- Sponsor
- Regeneron Pharmaceuticals
Cystic Fibrosis, Pancreatic Insufficiency
Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)
Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic…
- Trial name
- NCT00880100
- Testing
- Ultrase® MT12
- Where
- 15 sites in United States
- Volunteers
- 49 people
- Sponsor
- Forest Laboratories
Cow's Milk Protein Allergy (CMPA)
Safety and Efficacy Evaluation of an Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy (CMPA)
This is a prospective, multi-center, randomized, open-label, active-controlled, parallel-group, non-inferiority study. The goal of this clinical trial is to evaluate the clinical efficacy and safety of an extensively hydrolyzed…
- Trial name
- NCT07484035
- Testing
- Feihe Extensively Hydrolyzed Formula, Nestlé Extensively Hydrolyzed Formula
- Where
- 6 sites in China
- Volunteers
- 124 people
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Beta Thalassemia Major Anemia, Iron Overload
Safety and Efficacy of Early Treatment With Deferiprone in Infants and Young Children
This study is looking at the effects of giving early treatment of deferiprone to young children with beta thalassemia who have started receiving regular blood transfusions but have not yet reached the criteria for starting on…
- Trial name
- START (NCT03591575)
- Testing
- Deferiprone oral solution
- Where
- 4 sites in Egypt, Indonesia
- Volunteers
- 64 people
- Sponsor
- Chiesi Canada Corp
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
Primary Hyperoxaluria, Primary Hyperoxaluria Type 1 (PH1)
A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in infants and young children with confirmed primary hyperoxaluria type 1 (PH1).
- Trial name
- ILLUMINATE-B (NCT03905694)
- Testing
- Lumasiran
- Where
- 9 sites in United States, France and 3 more
- Volunteers
- 18 people
- Sponsor
- Alnylam Pharmaceuticals
Respiratory Syncytial Virus Lower Respiratory Tract Infection
Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
This was a randomized, double-blind, multicenter, Phase II study (NCT03418571) designed to support the selection of an optimal dose of inhaled ALX-0171 for further clinical development, taking ethnicity into consideration.
- Trial name
- NCT03418571
- Testing
- ALX-0171 1.5 mg/kg
- Where
- 25 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Ablynx, a Sanofi company
Pneumococcal Infectious Disease
PCV24 Clinical Trial in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months
The Phase II clinical trial of the 24-valent pneumococcal polysaccharide conjugate vaccine (RZ700) will be carried out in infants and young children aged 2 months (minimum 6 weeks) to 71 months.
- Trial name
- NCT07333352
- Testing
- 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700), 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13)
- Where
- 7 sites in China
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Reinovax Biologics Co., LTD
Healthy, Infant and Young Child Feeding
Effects of Staged Adapted Inclusions in Infant Cereals on Oral-motors Patterns of 6-24 Month-old Children
The purpose of this study is to define the effects of different inclusions in infant cereals on the adaptation of oral motor behavior and skills displayed at a given age.
- Trial name
- ICONIC (NCT07318506)
- Testing
- A, B, C
- Where
- 2 sites in Spain
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Dehydration
Subcutaneous Rehydration Compared to Intravenous Rehydration
Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.
- Trial name
- PEDs-II (NCT00773175)
- Testing
- recombinant human hyaluronidase
- Where
- 25 sites in United States
- Volunteers
- 148 people
- Sponsor
- Halozyme Therapeutics
Polio
Immunogenicity of After Primary Immunization and Booster Immunization of sIPV
This study was conducted on the basis of "Safety Observation of Sabin Strain Inactivated Polio Vaccine (Vero Cell) on primary Immunization, Booster Immunization and Simultaneous Vaccination with Other Vaccines in Infants and…
- Trial name
- NCT06058429
- Testing
- no intervention
- Where
- China
- Volunteers
- 233 people
- Sponsor
- Sinovac Biotech Co., Ltd
Meningococcal Meningitis
Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)
To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.
- Trial name
- NCT00310856
- Testing
- MenACWY-CRM, MenC-CRM, DTaP-Hib-IPV
- Where
- 3 sites in Canada
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Food Consumption, Infants
Nutri-Bébé 2013 Survey on Food Consumption of Infants and Young Children
The Nutri-Bébé 2013 survey is an observational cross-sectional study aiming to update food consumption, practices and nutrient intakes in children under 3 years of age in metropolitan France.
- Conditions
- Food Consumption, Infants, Toddlers
- Trial name
- NBB2013 (NCT03327415)
- Where
- France
- Volunteers
- 1,192 people
- Sponsor
- Secteur Français des Aliments de l'Enfance
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children
The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children.
- Trial name
- NCT03574389
- Testing
- 13vPnC, Hib
- Where
- 2 sites in China
- Volunteers
- 936 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Diarrhoea of Infants and/or Young Children
Oral Administration of Actitan-F in Paediatric Diarrhoea
The goal of the study is to investigate the efficacy and safety of Lenodiar Pediatric (product under investigation) for the treatment of Chronic Diarrhoea (functional or post-infective diarrhoea) in children aged 1-5 years old…
- Trial name
- NCT05904938
- Testing
- Lenodiar Pediatric
- Where
- 12 sites in Italy
- Volunteers
- 136 people
- Sponsor
- Aboca Spa Societa' Agricola