Clinical trials: Infant and Young Children
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
Bradycardia, Arrhythmias
Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants
An infants heart rate is very important because it ensures that blood is pumped to all organs in the body. Heart rate may decrease during anesthesia and surgery, and this is why the anesthesiologist will often give a medication…
- Trial name
- NCT01819064
- Testing
- Atropine
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- State University of New York at Buffalo
Hypophosphatasia
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042).
- Trial name
- NCT01205152
- Testing
- asfotase alfa
- Where
- 8 sites in United States, United Arab Emirates and 1 more
- Volunteers
- 10 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Iron Deficiency Anemia
Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia
This study is a randomized, controlled, double-blinded single center trial to compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional iron deficiency anemia (IDA) in infants and young children.
- Trial name
- BESTIRON (NCT01904864)
- Testing
- elemental iron (NovaFerrum®), elemental iron (Ferrous Sulfate)
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Texas Southwestern Medical Center
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
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
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
Diet, Healthy, Anemia
Mobile Messaging for Improved Nutrition
This project will examine the impact of an infant and young child feeding (IYCF) voice messaging intervention delivered to mothers and fathers in Senegal on the consumption of a minimum acceptable diet and anemia prevalence in…
- Trial name
- IIMAANJE (NCT05374837)
- Testing
- Infant and young child feeding voice messaging intervention
- Where
- Senegal
- Volunteers
- 488 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
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
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
Duchenne Muscular Dystrophy
Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy
While it has been known for many years that corticosteroid use benefits boys with Duchenne Muscular dystrophy (DMD), most clinicians do not consider treating until after age 3 or 4 years of age.
- Trial name
- NCT02167217
- Testing
- Prednisolone
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Washington University School of Medicine
Diabetes Mellitus, Type 2
Water Up@ At Home: An Intervention to Replace Sugary Drinks With Water
This study will test the preliminary effects of an intervention to reduce sugary drinks among low-income parents (n=38)(primary caregivers) and their young children (6 months-3 year olds) compared to a control group (n=38).
- Trial name
- NCT05159622
- Testing
- Water Up! at Home
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- George Washington University
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
Vaccination, Skin Absorption
Microneedle Patch Study in Healthy Infants/Young Children
Microneedles can be prepared as a low-cost patch that is simple for patients to apply for vaccine delivery targeting the many antigen-presenting cells present in the skin.
- Trial name
- NCT03207763
- Testing
- Microneedle Formulation 1, Microneedle Formulation 2
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Emory University
Malaria
Study to Assess the Vaccine Efficacy Against Malaria Infection, in Children Immunized With the Primary and Yearly Booster of the RTS,S/AS01E Vaccine, as Part of Their Participation in the Malaria-094 (204889/NCT03276962) Study.
The aim of this study was to evaluate the effectiveness of the RTS,S/AS01E malaria vaccine against both clinical and asymptomatic malaria infections by detecting Plasmodium falciparum (P.
- Trial name
- NCT03281291
- Where
- 2 sites in Ghana, Kenya
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive
Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis
Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main…
- Trial name
- EPIC (NCT00097773)
- Testing
- Tobramycin solution for inhalation (TOBI), Oral ciprofloxacin
- Where
- 54 sites in United States
- Volunteers
- 304 people
- Sponsor
- Seattle Children's Hospital
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
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
Cystic Fibrosis
Effectiveness of Pulmozyme in Infants With Cystic Fibrosis
This is a study to find out whether Pulmozyme is effective for clearing mucus from the airways of children with cystic fibrosis less than 3 ½ years of age.
- Trial name
- NCT00179998
- Testing
- Recombinant Human DNase (Pulmozyme)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Nationwide Children's Hospital
Cystic Fibrosis
Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis
Previous work demonstrated that inhaled hypertonic saline (HS) reduces exacerbation frequency and improves lung function in adults with cystic fibrosis (CF).
- Trial name
- NCT01031706
- Testing
- Hypertonic Saline
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of North Carolina, Chapel Hill