Clinical trials: Premature Neonates
Prematurity
A Clinical Trial of A Pacifier-Activated Music Player
Neonatal intensive care unit infants are at high risk for oromotor difficulties including poor coordination of sucking swallowing and breathing.
- Trial name
- NCT01600586
- Testing
- Pacifier-Activated-Lullaby system (PAL).
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Vanderbilt University Medical Center
Infant, Newborn, Diseases, Other Preterm Infants
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24…
- Conditions
- Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth
- Trial name
- SUPPORT (NCT00233324)
- Testing
- Surfactant, Continuous Positive Airway Pressure (CPAP), Supplemental oxygen with target saturation of 85 to 89%
- Where
- 22 sites in United States
- Volunteers
- 1,316 people
- Sponsor
- NICHD Neonatal Research Network
Preterm Delivery
Neonatal Outcome by Reason for Delivery
To determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM).
- Trial name
- NCT01818518
- Where
- 10 sites in United States
- Volunteers
- 995 people, healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
Neonates
NICU-TECH RM9L-RS Probe ME Feasibility Study
Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself.
- Trial name
- NCT01181596
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- GE Healthcare
Preterm Infant, Hypothermia, Newborn
Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates
The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known.
- Conditions
- Preterm Infant, Hypothermia, Newborn, Death, Kangaroo Mother Care
- Trial name
- eKMC (NCT03555981)
- Testing
- Early Kangaroo Mother Care, Standard care
- Where
- The Gambia
- Volunteers
- 279 people
- Sponsor
- London School of Hygiene and Tropical Medicine
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
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
Bronchopulmonary Dysplasia, Very Low Birth Weight
Preterm Infant Inhaled Albuterol Dosing
The purpose of this study is to help determine the best dose of inhaled albuterol sulfate in premature babies at risk of developing bronchopulmonary dysplasia (BPD).
- Trial name
- NCT02447250
- Testing
- Varied albuterol dose response
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Oregon Health and Science University
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
Infectious Diseases
Prevention of Necrotizing Enterocolitis of Premature Newborns Under Less Than 1500 g Using Probiotics
The purpose of this study is to evaluate the incidence of necrotizing enterocolitis and its effect over the secreting immunoglobulin A in the feces with the use of probiotics of the strain Lactobacillus acidophilus boucardii vs.
- Trial name
- (PEPP) (NCT02245815)
- Testing
- use probiotics boucardii, use probiotics Multi-species
- Where
- Mexico
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Infant, Premature, Diseases, Infant, Small for Gestational Age
Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3)…
- Trial name
- NCT02372136
- Testing
- Individualized Nutrition, Optimized nutrition
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Texas Southwestern Medical Center
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
Duchenne Muscular Dystrophy, Becker Muscular Dystrophy
Phase 2B Study of PTC124 (Ataluren) in Duchenne/Becker Muscular Dystrophy (DMD/BMD)
DMD/BMD 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.
- Trial name
- NCT00592553
- Testing
- Ataluren
- Where
- 37 sites in United States, Australia and 9 more
- Volunteers
- 174 people
- Sponsor
- PTC Therapeutics
Preterm Infants
Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
Preterm infants are a risk for multiple transfusions, and the administration of human recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements.
- Trial name
- NCT01235923
- Testing
- three times weekly Epo, weekly Epo
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of New Mexico
Hyperinsulinemia, Miscarriages
Maternal Lifestyle and Neonatal Hypoglycemia
tPA has a pivotal role in placentation, mediationg activation of growth factors, such as vascular endothelial growth factor and brain-derived neurotrophic factor, degradation of extracellular matrix and basement membrane…
- Conditions
- Hyperinsulinemia, Miscarriages, Pregnancy, Sedentary Lifestyle
- Trial name
- NCT01409382
- Testing
- Daily brisk walking plus a carbohydrate-restricted diet
- Where
- Brazil
- Volunteers
- 480 people
- Sponsor
- Hospital dos Servidores do Estado do Rio de Janeiro
Retinopathy of Prematurity (ROP)
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe…
- Trial name
- FIREFLEYE (NCT04004208)
- Testing
- Eylea (Aflibercept, BAY86-5321), Laser photocoagulation
- Where
- 90 sites in Argentina, Austria and 25 more
- Volunteers
- 113 people
- Sponsor
- Bayer
Premature Birth of Newborn
Supporting and Enhancing NICU Sensory Experiences (SENSE)
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St.
- Trial name
- SENSE (NCT03316547)
- Testing
- SENSE Program
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Preterm Delivery
A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
The hypothesis is that administration of two courses of antenatal corticosteroids, compared to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in patients delivering prior to 34 weeks'…
- Trial name
- ACS (NCT00201643)
- Testing
- Betamethasone or Dexamethasone (2nd course of ACS)
- Where
- 22 sites in United States
- Volunteers
- 437 people
- Sponsor
- Obstetrix Medical Group
Neonatal Infection
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in…
- Trial name
- EMSUP (NCT01540162)
- Where
- Ukraine
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Odessa National Medical University
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