Clinical trials: Obstetric Complication
Neonatal Respiratory Distress Syndrome, Extremely Low Birth Weight Infant (ELBW)
Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants
Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not well established.
- Conditions
- Neonatal Respiratory Distress Syndrome, Extremely Low Birth Weight Infant (ELBW), BronchoPulmonary Dysplasia
- Trial name
- EASEOFFNCPAP (NCT02819050)
- Testing
- NCPAP
- Volunteers
- 80 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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
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
Premature Birth of Newborn
Effects of Massage Therapy to Induce Sleep in Preterm Infants
Premature infants sometimes require sedation to ensure minimal movement during diagnostic procedures such as MRIs. However, sedatives may produce adverse effects.
- Trial name
- NCT01354028
- Testing
- Massage therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Arkansas
Infant, Newborn, Infant, Premature
Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates
The assessment and treatment of pain in neonates remains a challenge. In an effort to improve the quality of care while limiting opioid-related adverse effects, this study aims to determine the efficacy of a non-pharmacological…
- Conditions
- Infant, Newborn, Infant, Premature, Pain Perception, Pain Measurement
- Trial name
- NCT04050384
- Testing
- Baby GentleStick
- Where
- United States
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Lance M Relland, MD, PhD
Premature Birth
Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi
In this study, we test the effectiveness of an evidence-based model of group antenatal care by comparing it to individual (usual) antenatal care (Aim 1) across 7 antenatal clinics in Blantyre District, Malawi.
- Trial name
- NCT03673709
- Testing
- Antenatal Care
- Where
- 7 sites in Malawi
- Volunteers
- 1,887 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
Prematurity, Intestinal Permeability
Intestinal Permeability in Preterm Infants
Necrotizing enterocolitis (NEC) is a life-threatening, gastrointestinal emergency characterized by increased intestinal permeability, affects approximately 7 to 10% of infants <1500 g birthweight, and typically occurs within 7 to…
- Trial name
- IPPI (NCT01756040)
- Testing
- Lactulose -rhamnose solution
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- University of Maryland, Baltimore
Preterm Birth, Child Development
Omega Tots Long Term Follow-up
This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken…
- Trial name
- NCT05191823
- Testing
- Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
- Where
- United States
- Volunteers
- 377 people
- Sponsor
- Sarah Keim
Hypoxia
Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of…
- Trial name
- NCT01875159
- Testing
- Caffeine citrate 6 mg/kg/day
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- American SIDS Institute
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
Retinopathy of Prematurity
Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study
In premature infants, propranolol (Prop) treatment might suppress continuing neo-vascularization (NV) and decelerate the progression of retinopathy of prematurity (ROP) towards its severe stages (III-V), thus avoiding the need of…
- Trial name
- NCT01238471
- Testing
- propranolol, sucrose 5%
- Where
- 4 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Rambam Health Care Campus
Postpartum Depression, Small for Gestational Age at Delivery
Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention
In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder…
- Conditions
- Postpartum Depression, Small for Gestational Age at Delivery, Preterm Birth, Anxiety
- Trial name
- HMHB (NCT03880032)
- Testing
- Cognitive Behavioral Therapy Intervention for Anxiety
- Where
- Pakistan
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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
Candida Infection, Premature Infant
Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
This study evaluates whether adding a dietary supplement similar to coconut oil (MCT oil) to feedings in premature infants will reduce the amount of yeast (Candida) detectable in their stool.
- Trial name
- NCT03630770
- Testing
- Medium-Chain Triglyceride (MCT) Oil
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Joseph Bliss
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
Cholestasis
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid…
- Trial name
- NCT02663453
- Testing
- multicomponent lipid emulsion, pure soybean oil lipid emulsion
- Volunteers
- 44 people
- Sponsor
- Thammasat University
Postpartum Hemorrhage
Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.
- Trial name
- PEARLE (NCT02883673)
- Testing
- Jada System
- Where
- 15 sites in United States
- Volunteers
- 107 people
- Sponsor
- Alydia Health
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
Postpartum Hemorrhage
Effect of Adjunctive Misoprostol Treatment on Blood Loss at Vaginal Delivery
This document defines the Clinical Investigation Protocol for a study designed to determine whether blood loss after spontaneous vaginal delivery is altered by the addition of misoprostol administration to the standard use of…
- Trial name
- NCT02411916
- Testing
- misoprostol
- Where
- United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- New York City Health and Hospitals Corporation
Pre-term Birth, HIV-1-infection
Improving Pregnancy Outcomes With Progesterone
This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.
- Trial name
- IPOP (NCT03297216)
- Testing
- 17P
- Where
- 2 sites in Zambia
- Volunteers
- 800 people
- Sponsor
- University of North Carolina, Chapel Hill