Clinical trials: Pregnancy Preterm
Prematurity, Respiratory Insufficiency
Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)
This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure (NHRF).
- Conditions
- Prematurity, Respiratory Insufficiency, Pulmonary Hypertension, Respiratory Distress Syndrome, Newborn
- Trial name
- NCT01467076
- Testing
- Aerosolized Normal Saline, Inhaled PGE1
- Where
- 11 sites in United States
- Volunteers
- 7 people
- Sponsor
- NICHD Neonatal Research Network
Preterm Infant, Full-term Infant
A Novel Parent Education Program for Early Intervention
One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age.
- Trial name
- NCT04266717
- Testing
- Baby Play Intervention, Milestone Education
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Delaware
Preterm Birth, Child Development
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.
- Trial name
- NCT01576783
- Testing
- Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
- Where
- United States
- Volunteers
- 377 people
- Sponsor
- Sarah Keim
Pregnancy, Respiratory Distress Syndrome
Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in…
- Conditions
- Pregnancy, Respiratory Distress Syndrome, Pregnancy Outcomes, Preterm Birth
- Trial name
- ALPS (NCT01222247)
- Testing
- Betamethasone
- Where
- 17 sites in United States
- Volunteers
- 2,831 people, healthy volunteers welcome
- Sponsor
- The George Washington University Biostatistics Center
Chorioamnionitis
Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters) surrounding the baby inside of a pregnant woman prior to delivery.
- Trial name
- NCT00879190
- Testing
- Unasyn, Ampicillin/gentamicin
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Stanford University
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
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
Respiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or
Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab were administered sequentially to high-risk children during the same respiratory syncytial virus (RSV) season.
- Conditions
- Respiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or, Premature With Gestational Age <=35 Weeks and <=6 Months of Age
- Trial name
- NCT00316264
- Testing
- Motavizumab, palivizumab, Palivizumab, motavizumab, Motavizumab
- Where
- 19 sites in Australia, Chile and 1 more
- Volunteers
- 260 people
- Sponsor
- MedImmune LLC
Preterm Birth, Low Birth Weight <2500 Grams
Reducing Preterm Births in Underserved Pregnant Women
Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex.
- Conditions
- Preterm Birth, Low Birth Weight <2500 Grams, Verylow Birthweight <1500 Grams
- Trial name
- NCT01344616
- Testing
- lifestyle support
- Where
- United States
- Volunteers
- 482 people, healthy volunteers welcome
- Sponsor
- PHCC LP
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
PreTerm Birth
Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth
More than 1.5 million HIV-infected women become pregnant each year. Approximately half have access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB).
- Trial name
- VP (NCT02970552)
- Testing
- Vaginal Progesterone
- Where
- Zambia
- Volunteers
- 140 people
- Sponsor
- University of North Carolina, Chapel Hill
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
Extreme Prematurity
Preterm Erythropoietin Neuroprotection Trial (PENUT Trial)
Recombinant human erythropoietin (Epo) is a promising novel neuroprotective agent. Epo decreases neuronal programmed cell death resulting from brain injury; it has anti-inflammatory effects, increases neurogenesis, and protects…
- Trial name
- PENUT (NCT01378273)
- Testing
- Epo, Control
- Where
- 19 sites in United States
- Volunteers
- 941 people
- Sponsor
- University of Washington
Infant,Premature, Feeding; Difficult, Newborn
Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding
The investigators will establish an evidence base for the Nifty Feeding Cup by evaluating its effectiveness and caregiver satisfaction.
- Trial name
- NCT03280381
- Testing
- Nifty feeding cup, Generic medicine cup
- Where
- Ghana
- Volunteers
- 200 people
- Sponsor
- PATH
Preterm Birth
Tennessee Connections for Better Birth Outcomes
Women with a history of a prior preterm birth (PTB) have a high probability of a recurrent preterm birth. Some risk factors and health behaviors that contribute to PTB may be amenable to intervention.
- Trial name
- BBO (NCT00502697)
- Testing
- Targeted Nurse Home Visits, Conventional prenatal/postpartum care
- Where
- United States
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Preterm Birth
Oral Progesterone for Prevention of Preterm Birth
To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.
- Trial name
- NCT01180296
- Testing
- oral micronized progesterone
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Fetal Medicine Foundation
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.
Lactation
Recombinant Human Prolactin for Lactation Induction
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
- Trial name
- NCT00181610
- Testing
- Recombinant Human Prolactin, Normal Saline
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Massachusetts General Hospital
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
Chlamydia Trachomatis Infection, Neonatal Infection
Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on…
- Conditions
- Chlamydia Trachomatis Infection, Neonatal Infection, Preterm Birth, Gonorrhea
- Trial name
- NCT04955717
- Testing
- Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
- Where
- 2 sites in United States, Botswana
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Southern California