Clinical trials: Obstetric; Injury
Patent Ductus Arteriosus, Preterm Infant
Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
The purpose of the present study is to determine whether treatment of hemodynamically significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and oral acetaminophen has higher success rate in closing…
- Conditions
- Patent Ductus Arteriosus, Preterm Infant, Bronchopulmonary Dysplasia
- Trial name
- NCT03701074
- Testing
- Ibuprofen and acetaminophen
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of South Alabama
Bronchopulmonary Dysplasia
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated…
- Trial name
- TOLSURF (NCT01022580)
- Testing
- Infasurf surfactant (ONY, Inc.)
- Where
- 21 sites in United States
- Volunteers
- 511 people
- Sponsor
- Roberta Ballard
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
Prematurity, Respiratory Distress Syndrome
Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome
The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal…
- Trial name
- NCT00821119
- Testing
- nasal intermittent positive pressure ventilation
- Where
- 2 sites in Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Bronchopulmonary Dysplasia, Bronchopulmonary Dysplasia Associated Pulmonary Hypertension
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
Oral L-citrulline supplementation may prevent and/or decrease the severity of chronic lung disease associated with pulmonary hypertension in preterm infants.
- Conditions
- Bronchopulmonary Dysplasia, Bronchopulmonary Dysplasia Associated Pulmonary Hypertension, Pulmonary Hypertension, Premature Birth
- Trial name
- NCT03649932
- Testing
- Enteral L-citrulline
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Bronchopulmonary Dysplasia
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube).
- Trial name
- NCT01440647
- Testing
- Extubation to NIPPV, Extubation to CPAP
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Women and Infants Hospital of Rhode Island
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
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
Chorioamnionitis, Brain Injury
Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)
The purpose of this trial was to find the best dose of N-acetylcysteine (NAC) to decrease brain injury in babies exposed to intrauterine infection without causing significant side effects.
- Trial name
- NCT00724594
- Testing
- N-acetylcysteine, Control
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Medical University of South Carolina
Prematurity, Apnea
Caffeine to Reduce Mechanical Ventilation in Preterm Infants
Most premature infants require mechanical ventilation for prolonged periods of time and a significant proportion of them develop Bronchopulmonary Dysplasia (BPD).
- Conditions
- Prematurity, Apnea, Respiratory Failure
- Trial name
- NCT01751724
- Testing
- Caffeine citrate, Normal saline
- Where
- United States
- Volunteers
- 87 people
- Sponsor
- University of Miami
Bronchopulmonary Dysplasia
Trial II of Lung Protection With Azithromycin in the Preterm Infant
The hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of BPD.
- Trial name
- NCT00319956
- Testing
- Azithromycin
- Where
- United States
- Volunteers
- 220 people
- Sponsor
- Hubert Ballard
High Risk Pregnancy, Cesarean Wound Disruption With Postnatal Complication
Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients
This is a randomized controlled trial. Patients with a condition that increases their risk of a wound complication will be approached for inclusion in the trial.
- Trial name
- NCT03082664
- Testing
- PICO Single Use Negative Pressure Wound Therapy
- Where
- United States
- Volunteers
- 154 people
- Sponsor
- University of Arizona
Pain, Postpartum Depression
Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term.
- Trial name
- NCT03470675
- Testing
- Epidural saline + IV saline, Epidural morphine 3 mg + IV saline, Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Northwestern University
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
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), Bronchopulmonary Dysplasia
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
- Trial name
- TOLSURFPilot (NCT00569530)
- Testing
- Infasurf (ONY Inc.)
- Where
- 9 sites in United States
- Volunteers
- 85 people
- Sponsor
- Roberta Ballard
Obstetric Anal Sphincter Injury, Vaginal Electrical Stimulation
Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery
For too many women, childbirth results in devastating consequences: involuntary loss of feces or urine (fecal or urinary incontinence).
- Trial name
- VESPR (NCT02701413)
- Testing
- ApexM (Stimulation) Device
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Northwestern University
Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia
Relationship Between EIT and Respiratory Status in Very Preterm Infants
Electrical Impedance Tomography (EIT) is a non-invasive imaging technique that can measure lung function in real time. This study will follow premature infants to see if EIT can help predict which infants will be successful in…
- Conditions
- Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia, Premature Lungs
- Trial name
- NCT06609135
- Testing
- Sentec LuMon Device (EIT system), Sentec Digital Monitoring System (transcutaneous CO2 monitor)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Lawrence Rhein
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
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
Prematurity, Stress Reaction
Pilot Study of Nursing Touch and Biobehavioral Stress
Randomized cross-over clinical trial to determine the effect of a nurse-administered comforting touch intervention on the biobehavioral stress responses of preterm infants hospitalized in the neonatal intensive care unit.
- Trial name
- P-NAT-BIO (NCT05030233)
- Testing
- Nurse-Administered Touch Intervention
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Ohio State University