Clinical trials: Infant,Premature
Respiratory Syncytial Virus Infection
Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection
Published data by the Organización panamericana de la Salud shows that Peru's mortality rate from acute respiratory infections (ARI) in infants less than one year of life is second only to Haiti (14,150/100,000).
- Trial name
- INSPIRA (NCT01107535)
- Testing
- Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.
- Where
- 4 sites in Peru
- Volunteers
- 82 people
- Sponsor
- Abbott
RSV Immunization, Healthy Volunteer
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection…
- Trial name
- NCT05437510
- Testing
- Nirsevimab
- Where
- 240 sites in France, Germany and 1 more
- Volunteers
- 8,057 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Breastfeeding
Pilot Study of the FEEDBACK System for Use With Infants in the Neonatal Intensive Care Unit at University of Virginia
The purpose of this study is to assess the accuracy of FEEDBACK for measuring breastmilk intake of a pre-term baby. Mothers and babies will use the FEEDBACK system during a breastfeeding session in the NICU.
- Trial name
- NCT03702686
- Testing
- FEEDBACK System
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Molex Ventures LLC
Necrotizing Enterocolitis
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.
- Trial name
- NCT00977912
- Testing
- Probiotic supplementation
- Where
- 3 sites in South Africa
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Respiratory Distress Syndrome, Newborn
Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)
The aim of Alizé is to describe a population of premature babies (gestational age (GA) < 32 weeks) in real life situation and the management of RDS.
- Trial name
- NCT01102543
- Where
- France
- Volunteers
- 972 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
Respiratory Syncytial Virus Infections
A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months.
- Trial name
- JUBILUS (NCT06042049)
- Testing
- Nirsevimab
- Where
- 9 sites in Japan
- Volunteers
- 33 people
- Sponsor
- AstraZeneca
Late Onset Neonatal Sepsis, Necrotizing Enterocolitis
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis, Infant, Very Low Birth Weight
- Trial name
- NCT02073214
- Testing
- Probiotic
- Volunteers
- 182 people
- Sponsor
- IBSS Biomed S.A.
Respiratory Distress Syndrome
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
- Trial name
- NCT00807235
- Testing
- Aerosolized lucinactant
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Windtree Therapeutics
Cerebral Palsy, Periventricular Leukomalacia
A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy
UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.
- Trial name
- NCT04873752
- Testing
- UDI-001
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Rohto Pharmaceutical Co., Ltd.
Intraventricular Brain Hemorrhage
Detection and Quantification of Neonatal Intraventricular Hemorrhage
Dense array EEG and EIT (electrical impedence tomography) are new technologies that can add to information needed to diagnose neurological problems in infants - both preterm and term.
- Trial name
- DQNIH (NCT01899651)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Electrical Geodesics, Inc.
Cystic Fibrosis
Safety and Efficacy of Ataluren (PTC124) for Cystic Fibrosis
In some participants with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein.
- Trial name
- NCT00237380
- Testing
- Ataluren
- Where
- Israel
- Volunteers
- 24 people
- Sponsor
- PTC Therapeutics
Respiratory Syncytial Virus Infections
Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants
The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization rates and to begin to address the utilization of outpatient resources for RSV medically-attended lower respiratory tract infections…
- Trial name
- NCT00384462
- Where
- 59 sites in United States
- Volunteers
- 346 people
- Sponsor
- MedImmune LLC
Lower Respiratory Tract Infection
Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China
The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China
- Trial name
- CHIMES (NCT05110261)
- Testing
- Nirsevimab
- Where
- 30 sites in China
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Premature Birth
Human Milk Fortifier - Growth Evaluation
It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein…
- Trial name
- NCT01771588
- Testing
- Human milk fortifier
- Where
- 11 sites in Belgium, France and 3 more
- Volunteers
- 186 people
- Sponsor
- Société des Produits Nestlé (SPN)
Bronchopulmonary Dysplasia
Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants
The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.
- Trial name
- NCT03631420
- Testing
- Human Umbilical Cord Derived-Mesenchymal Stem Cells
- Where
- Taiwan
- Volunteers
- 9 people
- Sponsor
- Meridigen Biotech Co., Ltd.
Premature Infant
Effect of a Mixture of New Probiotic Strains in Preterm Infants
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0…
- Trial name
- PREBIOMA (NCT03701906)
- Testing
- Lactobacillus PS11603 & Bifidobacterium PS10402
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL
Necrotizing Enterocolitis
IBP-9414 for the Prevention of Necrotizing Enterocolitis
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
- Trial name
- NCT02472769
- Testing
- IBP-9414
- Where
- 15 sites in United States
- Volunteers
- 120 people
- Sponsor
- Infant Bacterial Therapeutics
Intestinal Malabsorption
Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.
- Trial name
- NCT05904626
- Testing
- ELGN-2112
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Elgan Pharma Ltd.
Mental Health Wellness 1, Preterm Birth
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth.
- Trial name
- MLI (NCT05012072)
- Testing
- The Mastery Lifestyle Intervention
- Where
- United States
- Volunteers
- 238 people
- Sponsor
- Microgen LLC