Clinical trials: Infants
Cystic Fibrosis
A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects.
- Trial name
- NCT03227471
- Testing
- IVA, TEZ/IVA, VX-445
- Where
- 38 sites in United States, Australia and 2 more
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Postpartum Depression, Postpartum Anxiety
Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care
The goal of the proposed research is to test the feasibility and acceptability of a virtual group session which is intended to be offered universally to Spanish-speaking parents of newborns/infants attending pediatric primary…
- Trial name
- NCT05423093
- Testing
- Single-Session Virtual Group Psychoeducational Session about Postpartum Depression
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Cystic Fibrosis
Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis
Direct measurement of mucociliary and cough clearance (MCC/CC) has been used as a biomarker in cystic fibrosis (CF). Additional knowledge of the performance of this biomarker is needed to inform exploratory clinical trial design…
- Trial name
- NCT01094704
- Testing
- sodium chloride (7%)
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- University of North Carolina, Chapel Hill
Infant Respiratory Distress Syndrome, Respiratory Insufficiency
Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
The purpose of this study is to test whether application of high frequency ventilation through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.
- Conditions
- Infant Respiratory Distress Syndrome, Respiratory Insufficiency, Apnea of Prematurity
- Trial name
- NCT00296231
- Testing
- Nasal high frequency ventilation
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Tarah T Colaizy
Cystic Fibrosis
A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare…
- Trial name
- CT03 Core (NCT00885365)
- Testing
- tobramycin / Bramitob, tobramycin / TOBI
- Where
- 44 sites in Czechia, France and 6 more
- Volunteers
- 324 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Leukemia, Myelodysplastic Syndromes
Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia
RATIONALE: Giving chemotherapy, such as busulfan, fludarabine, and melphalan, before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal or cancer cells and prepares the patient's bone marrow for…
- Conditions
- Leukemia, Myelodysplastic Syndromes, Childhood Acute Myeloid Leukemia in Remission, Recurrent Childhood Acute Myeloid Leukemia
- Trial name
- NCT00357565
- Testing
- filgrastim, busulfan, cyclosporine
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Growth Failure, X-linked Severe Combined Immunodeficiency (XSCID)
Treatment for Growth Failure in Patients With X-Linked Severe Combined Immunodeficiency: Phase 2 Study of Insulin-Like Growth Factor-1
This study will evaluate the safety and effectiveness of insulin-like growth factor-1 (IGF-1) to treat patients with X-linked severe combined immunodeficiency (XSCID).
- Conditions
- Growth Failure, X-linked Severe Combined Immunodeficiency (XSCID), Growth Hormone Resistence
- Trial name
- NCT00490100
- Testing
- Increlex
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infant, Newborn, Hypoxia, Brain
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT00614744
- Testing
- Hypothermia, Normothermic Control
- Where
- 22 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Short Bowel Syndrome
Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support.
- Trial name
- NCT03571516
- Testing
- Teduglutide, Standard Medical Therapy, Syringe
- Where
- 8 sites in Finland, France and 2 more
- Volunteers
- 10 people
- Sponsor
- Shire
Acute Kidney Injury, Hypoxia-Ischemia, Brain
Tissue Oxygenation During Treatment of Infant Congenital Heart Defects
Background: Acute kidney injury (AKI) is a common and serious postoperative complication in children with congenital heart disease.
- Conditions
- Acute Kidney Injury, Hypoxia-Ischemia, Brain, Mesenteric Ischemia
- Trial name
- NCT03941015
- Where
- China
- Volunteers
- 245 people
- Sponsor
- Beijing Anzhen Hospital
Feeding Behavior
Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics
The purpose of this study is to determine the effect of Semielevated Side-Lying (ESL) and Semielevated Supine Position (ESU) positions used in bottle-feeding of very preterm infants upon their physiological characteristics and…
- Trial name
- NCT02962609
- Testing
- Semielevated Side-lying Position-ESL, Semielevated Supine Position
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Istanbul University
Exocrine Pancreatic Insufficiency
Phase 1 Study to Assess Safety and Efficacy of ANG003
Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency.
- Trial name
- NCT06052293
- Testing
- ANG003
- Where
- 20 sites in United States
- Volunteers
- 57 people
- Sponsor
- Anagram Therapeutics, Inc.
Maternal Sepsis, Neonatal Sepsis
Smart Discharges for Mom & Baby
This study aims to build a predictive algorithm that identifies mother-newborn dyads most at risk of death or complications in the 6 weeks after birth.
- Trial name
- NCT05730387
- Testing
- Observational only
- Where
- Canada
- Volunteers
- 7,182 people
- Sponsor
- University of British Columbia
Cystic Fibrosis
Cystic Fibrosis and Endothelial Function: At Rest and During Exercise
Perhaps one of the most disturbing aspects of Cystic Fibrosis (CF) is the associated premature death. Oxidative stress has been observed in patients with CF and exercise intolerance has been shown to predict mortality in patients…
- Trial name
- NCT01772758
- Testing
- BH4 5mg, BH4 20mg, Antioxidant Cocktail
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Augusta University
Asthma
Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma
This study is a multicenter, stratified, randomized, active control, double-blinded, parallel-group comparative study with an open-label extension period.
- Trial name
- NCT02113436
- Testing
- FP/ SLM HFA MDI 50/25 mcg, FP HFA MDI 50 mcg
- Where
- 69 sites in Japan
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal, Meningococcal Vaccines
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines
The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age.
- Trial name
- NCT01144663
- Testing
- Nimenrix™, Menjugate®, NeisVac-CTM
- Where
- 44 sites in Estonia, Germany and 1 more
- Volunteers
- 2,095 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Inadequate; Pulmonary Ventilation, Newborn, Infant, Very Low Birth Weight
Nasal Noninvasive NAVA in the Very Low Birth Weight Infant
The purpose of this study is to determine if a new type of mechanical ventilation, or breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide additional support to infants who were born prematurely.
- Trial name
- NCT01785563
- Testing
- Nasal NIV-NAVA
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Tarah T Colaizy
Obesity, Infant, Language Development
Music and Child Health and Development
The goal of this clinical trial is to learn about the effects of a music enrichment program on the quality of parent child interactions, a child's motivation to eat, and a child's language environment in 9 to 24 month-old…
- Conditions
- Obesity, Infant, Language Development, Parent-Child Relations
- Trial name
- NCT05868811
- Testing
- Music Together, Play Group
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City
Pneumococcal Infections
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not previously been immunized with Pneumococcal…
- Trial name
- NCT00452452
- Testing
- 13-valent Pneumococcal Conjugate Vaccine
- Where
- 9 sites in Poland
- Volunteers
- 355 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Influenza
Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza
The purpose of this study is to learn how to treat influenza in children less than 2 years of age. Tamiflu®, the drug being studied, is approved for treatment of children 1 year of age and older with influenza.
- Trial name
- NCT00391768
- Testing
- oseltamivir (Tamiflu®)
- Where
- 32 sites in United States, Canada
- Volunteers
- 87 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)