Clinical trials: Premature Neonates
Bronchopulmonary Dysplasia
Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants
The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants.
- Trial name
- NCT01748045
- Testing
- inhaled nitric oxide
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Tufts Medical Center
Retinopathy of Prematurity
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP).
- Trial name
- BUTTERFLEYE (NCT04101721)
- Testing
- aflibercept, laser photocoagulation
- Where
- 52 sites in United States, Bulgaria and 11 more
- Volunteers
- 127 people
- Sponsor
- Regeneron Pharmaceuticals
Hemophilia A, Hemophilia B
Study of Ataluren (PTC124) in Hemophilia A and B
Hemophilia A (HA) and hemophilia B (HB) are inherited bleeding disorders caused by mutations in the gene for factor VIII (FVIII) and factor IX (FIX), respectively. These proteins are essential for blood clotting.
- Trial name
- NCT00947193
- Testing
- Ataluren
- Where
- 13 sites in United States, Canada and 2 more
- Volunteers
- 13 people
- Sponsor
- PTC Therapeutics
Premature Infant Disease, Family Research
PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU).
- Conditions
- Premature Infant Disease, Family Research, Parent-Child Relations, Self Efficacy
- Trial name
- NCT04638127
- Testing
- PREEMIE PROGRESS, Attention Control
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati
Idiopathic Hyperbilirubinemia, Neonatal Hyperbilirubinemia
Glycerin Suppositories to Reduce Jaundice in Premature Infants
The purpose of this study is to find out if giving glycerin suppositories will help decrease the length of time premature infants need phototherapy.
- Conditions
- Idiopathic Hyperbilirubinemia, Neonatal Hyperbilirubinemia, Prematurity
- Trial name
- NCT01746511
- Testing
- Phototherapy, glycerin suppository
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Respiratory Syncytial Virus Infections
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease.
- Trial name
- NCT01155193
- Volunteers
- 30,804 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Duchenne Muscular Dystrophy, Becker Muscular Dystrophy
Study of Ataluren for Previously Treated Participants With Nonsense Mutation Duchenne/Becker Muscular Dystrophy (nmDBMD) in Europe, Israel, Australia, and Canada
Duchenne/Becker muscular dystrophy (DBMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function.
- Conditions
- Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, Dystrophinopathy
- Trial name
- NCT01557400
- Testing
- Ataluren
- Where
- 21 sites in Australia, Belgium and 8 more
- Volunteers
- 94 people
- Sponsor
- PTC Therapeutics
Premature Intestinal Microbiota, Necrotizing Enterocolitis
Defining the Intestinal Microbiota in Premature Neonates
The investigators will collect daily faecal samples from premature (<32 weeks) infants in the intensive care unit from the day of birth until they are discharged.
- Conditions
- Premature Intestinal Microbiota, Necrotizing Enterocolitis, Late Onset Bloodstream Infection
- Trial name
- NCT01102738
- Where
- 3 sites in United Kingdom
- Volunteers
- 369 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Respiratory Distress Syndrome, Newborn
ABCA3 Gene and RDS in Late Preterm and Term Infants
Respiratory distress syndrome (RDS) is the most common respiratory cause of mortality and morbidity in very preterm infants, but it also could be seen in late preterm and term infants.
- Trial name
- NCT04137783
- Testing
- no intervention
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Children's Hospital of Chongqing Medical University
Bronchopulmonary Dysplasia
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5…
- Trial name
- NCT00931632
- Testing
- Inhaled Nitric Oxide
- Where
- 33 sites in United States, Canada
- Volunteers
- 451 people
- Sponsor
- Mallinckrodt
Neonatal Sepsis
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS).
- Trial name
- NCT05856227
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Bulgaria and 6 more
- Volunteers
- 9 people
- Sponsor
- Basilea Pharmaceutica
Respiratory Distress Syndrome (RDS)
A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration
This study compared the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA), using a thin catheter, CHF 6440 (LISACATH®), during non-invasive ventilation (CPAP, NIPPV, BiPAP)…
- Trial name
- LISPAP (NCT02772081)
- Testing
- LISA combination product (Curosurf+catheter CHF6440), Curosurf through conventional administration (endotracheal tube)
- Where
- 26 sites in United States
- Volunteers
- 33 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Dysphagia of Newborn
Cold Milk for Dysphagia in Preterm Infants
It is estimated that 30-70% of very low birth weight (VLBW) preterm infants will be diagnosed with swallowing dysfunction (dysphagia), which often leads to airway compromise in the form of laryngeal penetration and/or tracheal…
- Trial name
- NCT04421482
- Testing
- Standard room temperature (RTS) feeding of milk/formula, Cold temperature (CS, at 4-9°C) of milk/formula
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- NYU Langone Health
Neonatal Death, Prematurity
Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
BACKGROUND An essential part of neonatal care is providing nutrition to ensure that babies grow and develop. Providing this can be difficult in premature babies because their intestines are underdeveloped.
- Trial name
- NCT03767634
- Testing
- Parenteral nutrition
- Where
- United Kingdom
- Volunteers
- 97,507 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Healthy, Cystic Fibrosis (CF)
MRI for Non-Invasive Imaging in Neonates and Children
The purpose of this study is to develop rapid MRI techniques for imaging the lung with hyperpolarized helium-3 gas as an inhaled contrast agent.
- Conditions
- Healthy, Cystic Fibrosis (CF), Asthma, Bronchopulmonary Dysplasia (BPD)
- Trial name
- NCT02163681
- Testing
- Hyperpolarized Helium-3 MRI of the chest
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Respiratory Distress Syndrome
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks…
- Trial name
- NCT02074059
- Testing
- Lucinactant for Inhalation, nCPAP alone
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- Windtree Therapeutics
Prone Positioning, Bronchopulmonary Dysplasia
Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
In this pilot study, the investigator team aims to evaluate whether standardized prone positioning compared to usual positioning improves moderate to severe bronchopulmonary dysplasia (BPD) rates as assessed at 36 weeks post…
- Trial name
- NCT04890158
- Testing
- Prone positioning for a total of 6 hours daily
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Montefiore Medical Center
Neonatal Sepsis, Low Birth Weight
Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants
The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine affects skin condition, temperature, and bacterial colonization in stable preterm (28-36 weeks gestational age) low birth weight (1001-2000…
- Trial name
- NCT00947518
- Testing
- Chlorhexidine, Normal saline
- Volunteers
- 60 people
- Sponsor
- All India Institute of Medical Sciences
Preterm Birth, Tube Feeding
Maternal Role in Oral Feed Establishment in Preterm Neonates
Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will 1. Start taking oral feed at the same time as compared to control group 2.
- Conditions
- Preterm Birth, Tube Feeding, Swallowing Disorder, Maternal Care Patterns
- Trial name
- NCT05484726
- Testing
- perioral sensory motor stimulation
- Where
- Pakistan
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Fatima Memorial Hospital
Cystic Fibrosis
Study of Ataluren (PTC124) in Cystic Fibrosis
The primary objective of this study is to determine the long-term safety and tolerability of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) who completed participation in the double-blind study…
- Trial name
- NCT02107859
- Testing
- Ataluren
- Where
- 17 sites in United States, Belgium and 5 more
- Volunteers
- 61 people
- Sponsor
- PTC Therapeutics