Clinical trials: Preterm Birth
Preterm Birth
Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart pacemaker to deliver a weak electrical current to the human uterus that will rapidly and safely inhibit the unwanted premature uterine…
- Trial name
- NCT00212446
- Testing
- Electrical Intervention (EI)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- St. Luke's-Roosevelt Hospital Center
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
Respiratory Distress Syndrome in Premature Infants, Very Low Birth Weight Baby
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame.
- Trial name
- iNO (NCT01220687)
- Testing
- iNO, Nitrogen
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of Oklahoma
Prematurity, Respiratory Distress Syndrome
Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates.
- Conditions
- Prematurity, Respiratory Distress Syndrome, Patent Ductus Arteriosus
- Trial name
- CAST (NCT00767039)
- Testing
- Survanta (beractant), Curosurf (poractant)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Alan Fujii
Breast Milk Expression
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes…
- Trial name
- NCT01892085
- Testing
- Early initiation, Intermediate expression, Late initiation
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University of Florida
Apnea, Apnea Neonatal
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
A prospective, randomized open-label clinical trial will be conducted from July 2018 to October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke University Medical Center, the University of North…
- Conditions
- Apnea, Apnea Neonatal, Prematurity
- Trial name
- NCT03530124
- Testing
- PCV13, DTaP, HBV
- Where
- 4 sites in United States
- Volunteers
- 223 people
- Sponsor
- Duke University
Infections, Streptococcal
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis…
- Trial name
- NCT00390910
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Infanrix hexa
- Where
- 8 sites in Greece, Spain
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infant, Preterm
Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants
The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of…
- Trial name
- NCT01389882
- Testing
- neurally adjusted ventilatory assist (NAVA) ventilator mode
- Where
- South Korea
- Volunteers
- 26 people
- Sponsor
- Seoul National University Hospital
Infant, Newborn, Infant, Moderate Preterm
Incubator Weaning of Moderately Preterm Infants
The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants.
- Trial name
- NCT02160002
- Testing
- Weaning from an incubator at a lower weight (1600 grams), Weaning from an incubator at a higher weight (1800 grams)
- Where
- 18 sites in United States
- Volunteers
- 366 people
- Sponsor
- NICHD Neonatal Research Network
Prematurity, Neurodevelopmental Disorder
Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants
Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life.
- Conditions
- Prematurity, Neurodevelopmental Disorder, Carnitine Deficiency
- Trial name
- NCT01783041
- Testing
- L-carnitine, 5% Dextrose
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- Montefiore Medical Center
Preterm Infant, Early-Onset Neonatal Sepsis
Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
This study evaluates the utility of placental/umbilical cord blood (PUCB) to perform the baseline workup testing for EONS in Very Low Birth Weight Infants: CBC (Complete Blood Count) with differential, Immature/Total ratio (I/T…
- Conditions
- Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord
- Trial name
- NCT03694613
- Testing
- Placental/Umbilical Cord Blood sample
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- The University of Texas Medical Branch, Galveston
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
Preterm Birth, Extreme Prematurity
Sustained Aeration of Infant Lungs Trial
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants.
- Trial name
- SAIL (NCT02139800)
- Testing
- Sustained Inflation, Standard of Care
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 460 people
- Sponsor
- University of Pennsylvania
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
BPD Saturation TARgeting
Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage infants with established BPD.
- Conditions
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease
- Trial name
- BPD STAR (NCT03385330)
- Testing
- LOWER oxygen saturation target group, HIGHER oxygen saturation target group
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Children's Hospital of Philadelphia
Preterm Birth, Child Development
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help development and behavior of children born preterm.
- Conditions
- Preterm Birth, Child Development, Child Behavior
- Trial name
- NCT01683565
- Testing
- LCPUFA oil supplement
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Sarah Keim
Enterocolitis, Necrotizing, Premature Infant
NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies
The overall primary objective is to establish the feasibility and pilot the design and delivery of a diagnostic randomized controlled trial (RCT) of BUS (bowel ultrasound) for NEC evaluation which will lead to a successful…
- Trial name
- NCT03963011
- Testing
- Bowel Ultrasound
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Children's Mercy Hospital Kansas City
Pregnancy, Premature Rupture of Membranes
Cervical Ripening in Premature Rupture of Membranes
Premature rupture of membranes (PROM) is diagnosed by demonstrating amniotic fluid in the vaginal canal before the onset of labor.
- Conditions
- Pregnancy, Premature Rupture of Membranes, Preterm Premature Rupture of Membranes, Unfavorable Cervix
- Trial name
- NCT02314728
- Testing
- Misoprostol, Oxytocin
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Preterm Infants, Dolichocephaly
Treatment of Cranial Molding Deformities in Preterm Infants
The purpose of this study is to determine the effectiveness of the Tortle Midliner positioning system in prevention and/or treatment of dolichocephaly, which can develop in preterm infants during the hospital stay.
- Conditions
- Preterm Infants, Dolichocephaly, Positional Scaphocephaly
- Trial name
- NCT02366936
- Testing
- Tortle Midliner
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Duke University
Preterm Birth
Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth
The study plans to determine the relationship between plasma concentrations of 17-OHPC hydroxyprogesterone caproate (17-OHPC) and the rate of preterm birth.
- Trial name
- PRO (NCT03292731)
- Testing
- 17-Hydroxyprogesterone caproate 250mg or 500 mg., Safety study of 500 mg dose.
- Where
- 5 sites in United States
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Steve N. Caritis, MD
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