Clinical trials: Infants
Patent Ductus Arteriosus, Prematurity
Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of…
- Trial name
- NCT00833365
- Testing
- Ibuprofen
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Utah
Respiratory Distress Syndrome, Newborn
Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation
In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube…
- Trial name
- NCT01042600
- Testing
- Endotracheal tube insertion, Laryngeal mask airway insertion
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Albany Medical College
RDS of Prematurity
NIV Strategies for RDS in Preterm Infants. NIV (Non Invasive Ventilation), RDS (Respiratory Distress Syndrome)
The purpose of this study is to determine whether two different strategies of Non Invasive Ventilation (NIV) have different effect on length and failure of NIV support in preterm infants with respiratory distress syndrome (RDS).
- Trial name
- NIV (NCT02259400)
- Testing
- NSIPPV, BiPAP
- Volunteers
- 280 people
- Sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Cystic Fibrosis
A Two-Part Multicenter Prospective Longitudinal Study of CFTR-dependent Disease Profiling in Cystic Fibrosis (PROSPECT)
identify and validate biomarkers that might reflect partial restoration of CFTR function and can be used to monitor disease progression, and ii) evaluate the mechanistic effects of CFTR modulators and other relevant therapies in…
- Trial name
- PROSPECT (NCT02477319)
- Testing
- Observational
- Where
- 38 sites in United States
- Volunteers
- 452 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Fabry Disease, Alpha Galactosidase A Deficiency
Study of the Effects of Fabrazyme Treatment on Lactation and Infants
The study was planned for up to 2 years (24 months). Planned full participation for both mother and infant was 24 months, planned full participation of mother and development of infant was 24 months, while planned full…
- Trial name
- NCT00230607
- Testing
- agalsidase beta
- Where
- 5 sites in United States, Austria and 1 more
- Volunteers
- 7 people
- Sponsor
- Genzyme, a Sanofi Company
Cystic Fibrosis
A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg b.i.d. in subjects aged 18 years and above. We hypothesize that inhaled mannitol 400 mg b.i.d.
- Trial name
- NCT02134353
- Testing
- Inhaled mannitol
- Where
- 100 sites in United States, Argentina and 16 more
- Volunteers
- 423 people
- Sponsor
- Syntara
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
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic…
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Trial name
- NCT01529827
- Testing
- fludarabine phosphate, melphalan, total-body irradiation
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Roswell Park Cancer Institute
Deglutition Disorders, Respiratory Distress Syndrome In Premature Infants
Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates
Oral feeding of neonates while on nasal continuous positive airway pressure (NCPAP) is a common practice in many neonatal intensive care units (NICU) all over the country.
- Conditions
- Deglutition Disorders, Respiratory Distress Syndrome In Premature Infants, Respiratory Aspiration, Newborn, Premature
- Trial name
- NCT02661256
- Testing
- NCPAP, Varibar® Thin Liquid Barium Sulfate for Suspension
- Volunteers
- 7 people
- Sponsor
- NYU Langone Health
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight
Transfusion of Prematures Trial
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of…
- Conditions
- Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD)
- Trial name
- TOP (NCT01702805)
- Testing
- Liberal Cell Transfusion, Restricted red cell transfusion
- Where
- 20 sites in United States
- Volunteers
- 1,824 people
- Sponsor
- NICHD Neonatal Research Network
Adverse Reaction to Drug, Neonatal Disorder
Exploratory Propofol Dose Finding Study In Neonates
The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure…
- Trial name
- NEOPROP (NCT01621373)
- Testing
- propofol administration
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Tuberculosis
Study of AERAS-402 in Healthy Infants
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
- Trial name
- NCT01198366
- Testing
- AERAS-402 1.5 x 10^10 vp, AERAS-402 3.0 x 10^10 vp, AERAS-402 1.0 x 10^11 vp
- Where
- 7 sites in Kenya, Mozambique and 1 more
- Volunteers
- 487 people, healthy volunteers welcome
- Sponsor
- Aeras
Bronchopulmonary Dysplasia
Analysis of BPD in Premature Infants With Typical Imaging Changes
Bronchopulmonary dysplasia (BPD) is a common chronic respiratory disease in preterm infants. The increase in the survival rate of premature babies following the improvement of perinatal treatment and care has caused an increase…
- Trial name
- NCT04163822
- Testing
- no intervention
- Where
- China
- Volunteers
- 256 people
- Sponsor
- Wang Jianhui
Prematurity, Very Preterm Maturity of Infant
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1.
- Trial name
- NCT05711927
- Testing
- SNOO Smart Sleeper, Traditional bassinet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Columbia University
PPROM, Respiratory Distress Syndrome in Premature Infants
Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care…
- Trial name
- NCT02939742
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam
The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in…
- Trial name
- NCT01153841
- Testing
- Synflorix™( GSK1024850A), Infanrix hexa™
- Where
- Vietnam
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pneumococcal Vaccines
Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine…
- Trial name
- NCT00464945
- Testing
- 13-valent Pneumococcal Conjugate Vaccine
- Where
- 9 sites in Poland
- Volunteers
- 269 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Spinal Muscular Atrophy
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA)
The primary objective is to examine the clinical efficacy of multiple doses of nusinersen (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular Atrophy (SMA).
- Trial name
- NCT01839656
- Testing
- nusinersen
- Where
- 4 sites in United States, Canada
- Volunteers
- 21 people
- Sponsor
- Biogen
Rotavirus, Gastroenteritis
Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.
- Trial name
- NCT00718237
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
- Volunteers
- 762 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC