Clinical trials: Infants and Young Children
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
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
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)
Cardiac Disease, Respiratory Disease
Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)
Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and movements of the subject.
- Conditions
- Cardiac Disease, Respiratory Disease, Congenital Cardiac Defect, Cardiovascular Diseases
- Trial name
- BRIDGE (NCT05319236)
- Testing
- Gabi System
- Where
- 4 sites in United States, Belgium
- Volunteers
- 101 people
- Sponsor
- Gabi SmartCare
Healthy
A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children
Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to < 60 months of age, with 28-day shedding follow-up and 180-day safety…
- Trial name
- NCT00344305
- Testing
- Trivalent influenza virus vaccine live, intranasal
- Where
- 16 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
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
Growth
BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)
The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.
- Trial name
- NCT04957992
- Testing
- Control Infant Formula, Control Toddler Drink, Experimental Infant Formula
- Where
- 42 sites in United States
- Volunteers
- 607 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Infant, Small for Gestational Age
Genotropin Treatment In Very Young Children Born Small For Gestational Age
To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.
- Trial name
- EGN (NCT00627523)
- Testing
- Genotropin (PN-180,307) Somatropin, Control-no treatment
- Where
- 17 sites in Belgium, Czechia and 7 more
- Volunteers
- 43 people
- Sponsor
- Pfizer
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
Healthy Children
Study to Evaluate the Effects of a Formula on the Gut Health of Healthy Chinese Infants and Young Children
The infant gut microbiota, a major driver of the maturation of the immune system, is formed through the successive establishment and development during infancy and early childhood.
- Trial name
- NCT04864665
- Testing
- a formula with prebiotics and milk fat
- Where
- 6 sites in China
- Volunteers
- 455 people, healthy volunteers welcome
- Sponsor
- Danone Nutricia
Achondroplasia
Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)
This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants < 3 years old with ACH.
- Trial name
- NCT07169279
- Testing
- Infigratinib is provided as a single dose of minitablets for oral administration, Infigratinib is provided as sprinkle capsules for daily oral administration
- Where
- 12 sites in United States, Australia and 5 more
- Volunteers
- 77 people
- Sponsor
- QED Therapeutics, a BridgeBio company
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
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
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
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
Respiratory Syncytial Virus Infection
Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions
To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.
- Trial name
- NCT01466062
- Testing
- Palivizumab
- Where
- 6 sites in Japan
- Volunteers
- 28 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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
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
Cow's Milk Protein Allergy
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy
The purpose of the study is to determine whether a new hydrolyzed rice protein-based formula is hypoallergenic in infants and young children with documented Immunoglobulin E (IgE)-mediated Cow Milk Protein Allergy (CMPA).
- Trial name
- RIGHT-HY (NCT06633289)
- Testing
- Experimental formula, Control formula
- Where
- 11 sites in Germany, Italy and 1 more
- Volunteers
- 43 people
- Sponsor
- Société des Produits Nestlé (SPN)