Clinical trials: Infant, Extremely Premature
Bronchopulmonary Dysplasia, Extremely Premature Infants
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia
Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD).
- Conditions
- Bronchopulmonary Dysplasia, Extremely Premature Infants, Severe BPD That Conventional Therapies Has Failed, No Severe Congenital Anomalies
- Trial name
- NCT01207869
- Testing
- ucMSCs, Normal saline
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- China Medical University Hospital
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Influenza, Infant, Premature
Influenza Vaccine in Premature Infants
Background. Influenza is increasingly recognized as causing severe respiratory illness in children. High-risk infants, like former premature infants, and particularly those with lung disease, have influenza hospitalization rates…
- Trial name
- NCT00455169
- Testing
- Trivalent Inactivated Influenza Vaccine
- Where
- 5 sites in United States
- Volunteers
- 66 people
- Sponsor
- University of Rochester
Infant, Newborn, Infant, Low Birth Weight
Physiologic Definition of Bronchopulmonary Dysplasia
This observational study was conducted to design and test a physiologic definition for bronchopulmonary dysplasia at 36 weeks of life.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- PhysiologicDef (NCT01223287)
- Where
- 21 sites in United States
- Volunteers
- 410 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Surfactant 1 (NCT01203358)
- Testing
- Exosurf, Survanta
- Where
- 13 sites in United States
- Volunteers
- 617 people
- Sponsor
- NICHD Neonatal Research Network
Neonatal Prematurity, Hypotension
Effects of Transitional Circulation in ELBW Infants
Prematurity is a very important problem in this country. Prematurity can cause problems with organ (such as the brain, heart, kidneys) growth and development.
- Trial name
- NCT02016599
- Testing
- Monitoring and biospecimen collection
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of Iowa
Bronchopulmonary Dysplasia
Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.
A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of…
- Trial name
- NCT01268215
- Testing
- Infasurf, Pulmicort
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- East Carolina University
Neonatal Resuscitation, Apnea Neonatal
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method.
- Trial name
- MVP (NCT06849596)
- Testing
- Ventilator derived positive pressure ventilation - V-PPV, T-piece resuscitator (TPR)
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 780 people
- Sponsor
- Michelle Baczynski
Cholestasis
Cholestasis in Extreme Low Birth Weight Infants (ELBW)
Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (PNAC).
- Trial name
- NCT01164878
- Volunteers
- 122 people
- Sponsor
- Medical University of Vienna
Infant, Newborn, Infant, Low Birth Weight
Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A and determine if this would increase the rate of survival without bronchopulmonary dysplasia (BPD) and reduce…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Vitamin A (NCT01203488)
- Testing
- Vitamin A
- Where
- 11 sites in United States
- Volunteers
- 807 people
- Sponsor
- NICHD Neonatal Research Network
Prematurity Complications, Neurodevelopment Outcome
Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants
The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births…
- Conditions
- Prematurity Complications, Neurodevelopment Outcome, Prematurity
- Trial name
- OutbornTRANSF (NCT07580859)
- Testing
- Usual Care
- Where
- France
- Volunteers
- 627 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
BPD - Bronchopulmonary Dysplasia
Impact of Steroid, Diuretic, and Fluid Use on BPD Outcomes
Assess the impact of steroid, diuretic, and fluid practices on BPD outcomes in extreme premature infants in the Banner - University Medical Center Phoenix (BUMCP) neonatal intensive care unit (NICU).
- Trial name
- NCT04971694
- Testing
- No interventions or procedures
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- Pediatrix
Retinopathy of Prematurity (ROP)
Inositol to Reduce Retinopathy of Prematurity
This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without severe Retinopathy of Prematurity (ROP)…
- Trial name
- INS-3 (NCT01954082)
- Testing
- myo-Inositol 5% Injection
- Where
- 19 sites in United States
- Volunteers
- 638 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Preemie iNO (NCT00016523)
- Testing
- Inhaled nitric oxide
- Where
- 17 sites in United States
- Volunteers
- 420 people
- Sponsor
- NICHD Neonatal Research Network
Caregiver Feeling
Feeling of Caregivers After a Palliative Management of Extreme Premature Babies in Delivery Room.
Introduction : The birth of a child is usually a happy event that caregivers working in delivery rooms share with families. Unfortunately, newborns sometimes need palliative care as soon as birth occurs.
- Trial name
- NCT06458114
- Testing
- Assessment of caregiver feeling
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CHU de Reims
Infant, Premature, Respiratory Disease
Extremely Preterm Respiratory Outcome Cohort
This study examines the respiratory outcomes of preterm infants born at gestational ages less than 29 weeks, spanning from birth to 24 months corrected age.
- Trial name
- NCT06726226
- Testing
- Standard care for preterm infants
- Where
- South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants.
- Conditions
- Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Necrotizing Enterocolitis
- Trial name
- NCT05311228
- Testing
- Azithromycin Powder
- Where
- Indonesia
- Volunteers
- 120 people
- Sponsor
- Universitas Indonesia
Pregnancy Complications, Maternal Death
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are: 1.
- Conditions
- Pregnancy Complications, Maternal Death, Preeclampsia, Intrauterine Infection
- Trial name
- MONAS (NCT06268509)
- Testing
- Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health), Fetomaternal ultrasound
- Where
- Indonesia
- Volunteers
- 245 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Prematurity; Extreme, Cerebral Circulatory Failure
Sonographic QUantification of Venous Circulation In the Preterm Brain
The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an…
- Conditions
- Prematurity; Extreme, Cerebral Circulatory Failure, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Trial name
- SQUIB (NCT04535375)
- Testing
- Doppler Ultrasound of venous cerebral circulation
- Where
- Belgium
- Volunteers
- 47 people
- Sponsor
- Universitair Ziekenhuis Brussel
Respiratory Distress Syndrome, Newborn, Respiratory Failure
Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation
The aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the extremely preterm infants.
- Conditions
- Respiratory Distress Syndrome, Newborn, Respiratory Failure, Premature Birth
- Trial name
- NCT04391634
- Testing
- volume guarantee, pressure-controlled
- Where
- Poland
- Volunteers
- 25 people
- Sponsor
- Poznan University of Medical Sciences