Clinical trials: Infant
Lysosomal Acid Lipase Deficiency
Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency
This study evaluated the safety and efficacy of sebelipase alfa in a broad population of participants with lysosomal acid lipase deficiency (LAL-D).
- Trial name
- NCT02112994
- Testing
- Sebelipase Alfa
- Where
- 19 sites in United States, Australia and 13 more
- Volunteers
- 31 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Respiratory Tract Infections
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
- Trial name
- DAISY (NCT04583280)
- Testing
- Rilematovir, Rilematovir X mg/kg
- Where
- 142 sites in United States, Argentina and 24 more
- Volunteers
- 28 people
- Sponsor
- Janssen Research & Development, LLC
Cystic Fibrosis
Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)
A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P.
- Trial name
- NCT00777296
- Testing
- ARIKACE™
- Where
- 11 sites in Belgium, Hungary and 5 more
- Volunteers
- 66 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
- Trial name
- NCT04362761
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 29 sites in Australia, Belgium and 2 more
- Volunteers
- 172 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Meningitis, Meningococcal
Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
- Trial name
- NCT00798304
- Testing
- meningococcal B rLP2086 vaccine, Routine age appropriate childhood vaccines
- Where
- 7 sites in Spain
- Volunteers
- 46 people
- Sponsor
- Pfizer
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine.
- Trial name
- NCT01480258
- Testing
- PR5I, Rotavirus vaccine, Prevenar 13™
- Volunteers
- 1,315 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Healthy Volunteers, Haemophilus Influenzae Type b, Prevention
Phase III Study of Intramuscular TAK-816 in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants.
- Trial name
- NCT02074345
- Testing
- TAK-816
- Where
- 4 sites in Japan
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Takeda
Gastroschisis
Probiotics in Infants With Gastroschisis
Infants born with gastroschisis usually require surgery shortly after birth. After surgery the intestine is often unable to digest human milk or formula for weeks or months.
- Trial name
- NCT01316510
- Testing
- Bifidobacteria infantis
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of California, Davis
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency…
- Trial name
- NCT01327703
- Testing
- Panzytrat® 25,000, Kreon® 25,000
- Where
- 13 sites in Germany, Poland
- Volunteers
- 87 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation…
- Trial name
- TRAFFIC (NCT01807923)
- Testing
- Lumacaftor Plus Ivacaftor Combination, Ivacaftor
- Where
- 89 sites in United States, Australia and 9 more
- Volunteers
- 559 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Spinal; Puncture, Complications
Ultrasound vs Palpation for Infant Lumbar Puncture
The purpose of this study is to determine if performing an ultrasound to identify the space to insert the needle before performing a lumbar puncture will improve success of the procedure and patient safety.
- Trial name
- NCT02373774
- Testing
- Ultrasound
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Columbia University
Meningitis, Meningococcal, Rotavirus Infections
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine.
- Trial name
- NCT00443846
- Testing
- RotaTeq®, NeisVac-C®
- Volunteers
- 247 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus
V260 Registration Study (V260-013)(COMPLETED)
Immunogenicity and Safety of V260 in Healthy Infants in Korea
- Trial name
- NCT00166517
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Malaria
A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Children in Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine
The purpose of this pre-licensure cohort study was to estimate the incidence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis and malaria in sub-Saharan…
- Trial name
- NCT02374450
- Testing
- Blood collection
- Where
- 5 sites in Burkina Faso, Ghana and 1 more
- Volunteers
- 36,366 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Haemophilus Influenza
A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine
Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children.
- Trial name
- NCT02692859
- Testing
- Hib conjugate vaccine
- Volunteers
- 1,992 people, healthy volunteers welcome
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability.
- Conditions
- Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy, Birth Asphyxia
- Trial name
- NEATO (NCT01913340)
- Testing
- Erythropoietin, Normal saline
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco
Pneumococcal Infections
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations…
- Trial name
- NCT00452790
- Testing
- 13-valent Pneumococcal Conjugate Vaccine, 7 valent pneumococcal conjugate vaccine
- Where
- 12 sites in India
- Volunteers
- 708 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Congenital Hyperinsulinism
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism.
- Trial name
- NCT00897676
- Testing
- Exendin-(9-39)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Diva De Leon
Pain, Retinopathy of Prematurity
Proparacaine and Mydriatic Eye Drops
In this study, we will be evaluating whether premedication with an anesthetic eye drops leads to a decreased sensation of pain when given dilating eye drops prior to eye examinations to evaluate for retinopathy of prematurity in…
- Trial name
- NCT01266824
- Testing
- Proparacaine Hydrochloride Ophthalmic Solution
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Children's Hospital of Philadelphia
Preterm Infants, Parenteral Nutrition n-3 Fatty Acids
Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory…
- Trial name
- NCT00497289
- Testing
- Lipofundin MCT/LCT 20 %, Lipidem 20%
- Where
- 2 sites in Germany
- Volunteers
- 48 people
- Sponsor
- B. Braun Melsungen AG