Clinical trials: Pregnancy Preterm
Prematurity
Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants
Background: Infection in preterm infants is a common, costly, and devastating problem frequently causing death or sequelae for survivors.
- Trial name
- NCT01776268
- Testing
- Oral priming
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Vanderbilt University Medical Center
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
Premature Birth, Brain Injury
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may reduce this risk. The unborn baby receives melatonin from the mother but following premature delivery there maybe a period of prolonged…
- Trial name
- MIND (NCT00649961)
- Testing
- Melatonin injection
- Where
- 2 sites in United Kingdom
- Volunteers
- 18 people
- Sponsor
- Imperial College London
Kangaroo Mother Care, Preterm Infant
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care.
- Conditions
- Kangaroo Mother Care, Preterm Infant, Death; Neonatal, Hypothermia, Newborn
- Trial name
- OMWaNA (NCT02811432)
- Testing
- Kangaroo mother care, Standard care
- Where
- 4 sites in Uganda
- Volunteers
- 2,221 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Premature Birth
Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth.
- Trial name
- ASPIRIN (NCT02409680)
- Testing
- Low dose aspirin
- Where
- 14 sites in United States, Democratic Republic of the Congo and 5 more
- Volunteers
- 11,976 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
Prematurity, Bronchopulmonary Dysplasia
Inhaled Nitric Oxide and Neuroprotection in Premature Infants
The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.
- Conditions
- Prematurity, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Trial name
- NOVA2 (NCT00515281)
- Testing
- inhaled nitric oxide, oxygen
- Where
- United States
- Volunteers
- 273 people
- Sponsor
- University of Chicago
Respiratory Distress Syndrome
Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
Multiple different devices are available to provide Bubble CPAP to preterm and newborn infants. The most significant difference between these devices is the size of the bubble produced by the exhalation limb.
- Trial name
- NCT02392806
- Testing
- Bubble CPAP- BabiPlus, Respiralogics, Bubble CPAP- B&B Bubbler, B&B Medical devices
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Marya Strand, MD
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
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
Premature Rupture of Membranes
FOLCROM Trial: Foley Catheter in Rupture of Membranes
Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.
- Trial name
- FOLCROM (NCT01973036)
- Testing
- Foley Catheter, Oxytocin
- Where
- 5 sites in United States
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Geisinger Clinic
Premature Birth of Newborn, Intervention Studies
Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
This is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.
- Trial name
- NCT02508571
- Testing
- Direct swallowing training (DST), Oral sensorimotor stimulation (OSMS)
- Where
- South Korea
- Volunteers
- 189 people
- Sponsor
- Seoul National University Hospital
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
Premature Birth, Absorption; Chemicals
17OHP-C Dosing Among Obese Pregnant Women
Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher doses of 17OHP-C may help to prevent spontaneous PTB…
- Trial name
- NCT03433040
- Testing
- 17-Hydroxyprogesterone Capronate
- Where
- 2 sites in United States
- Volunteers
- 44 people
- Sponsor
- University of South Florida
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
Respiratory Distress Syndrome, Newborn, Respiratory Tract Diseases
Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2
To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal…
- Trial name
- NCT02340299
- Testing
- nHFOV, nCPAP
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- Charite University, Berlin, Germany
Premature Rupture of Fetal Membranes
Evaluation of CRB in PROM Patients
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).
- Trial name
- NCT01736852
- Testing
- CRB, Pitocin
- Where
- 4 sites in United States
- Volunteers
- 129 people
- Sponsor
- Cook Group Incorporated
Preterm Birth, Short Cervix
Prevention of Preterm Birth With a Pessary in Singleton Gestations
Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually.
- Trial name
- PoPPS (NCT02056652)
- Testing
- Bioteque cup pessary
- Where
- 4 sites in United States
- Volunteers
- 122 people
- Sponsor
- University of Pennsylvania
Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome
The Budesonide in Babies (BiB) Trial
This is a Phase 3, randomized, masked, active-controlled, multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant, as compared to surfactant alone, will…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome, Prematurity; Extreme, Neonatal
- Trial name
- BiB (NCT04545866)
- Testing
- budesonide (Pulmicort nebulizing suspension)., surfactant (poractant alfa;Curosurf)
- Where
- 19 sites in United States
- Volunteers
- 642 people
- Sponsor
- NICHD Neonatal Research Network
Premature Birth of Newborn, Intestinal Malabsorption
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
- Trial name
- NCT02510560
- Testing
- NTRA-2112
- Where
- 50 sites in United States, Belgium and 8 more
- Volunteers
- 300 people
- Sponsor
- Elgan Pharma Ltd.
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