Clinical trials: Preterm Pregnancy
Premature Birth, Pregnancy Preterm
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study
This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 674 Medi-Cal eligible pregnant individuals in Fresno, California.
- Conditions
- Premature Birth, Pregnancy Preterm, Prenatal Stress, Depression, Anxiety
- Trial name
- EMBRACE (NCT04154423)
- Testing
- Glow! Group Prenatal Care, Individual Prenatal Care with CPSP
- Where
- 2 sites in United States
- Volunteers
- 678 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Apnea, Apnea Neonatal
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
A prospective, randomized open-label clinical trial will be conducted from July 2018 to October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke University Medical Center, the University of North…
- Conditions
- Apnea, Apnea Neonatal, Prematurity
- Trial name
- NCT03530124
- Testing
- PCV13, DTaP, HBV
- Where
- 4 sites in United States
- Volunteers
- 223 people
- Sponsor
- Duke University
Docosohexaenoic Acid Supplementation of Mothers to
DHA Supplementation for Lactating Mothers
The purpose of this research study is to find out whether preterm infants are receiving enough of the essential and long chain fatty acids important for brain development and immune function.
- Trial name
- DHA-1 (NCT01732874)
- Testing
- Expecta 200 mg, Expecta 1 gram
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Preterm Labor
Nifedipine for Acute Tocolysis of Preterm Labor
The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.
- Trial name
- Nifedipine (NCT02132533)
- Testing
- Nifedipine, Usual care
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- University of Texas Southwestern Medical Center
Preterm Birth
Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan
The purpose of this study is to pilot an intervention that was developed to improve uptake and adhere to an Individualized Prematurity Prevention Plan (IP3) for preterm birth prevention.
- Trial name
- NCT04149002
- Testing
- Intervention Arm Weekly IP3 text messages, Active Control Arm General pregnancy text messages
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Prematurity, Intestine Perforation
Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies
Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common devastating gastrointestinal diseases in premature infants.
- Conditions
- Prematurity, Intestine Perforation, Necrotizing Enterocolitis (NEC), Short Bowel Syndrome (SBS)
- Trial name
- EMLFO-2 (NCT01674478)
- Testing
- Microlipid with fish oil, Microlipid
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Wake Forest University
Hyponatremia, Premature
Early Sodium Intake in Preterm Newborns
Hyponatremia is a common complication among preterm infants, renal losses of sodium contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact in newborns outcome.
- Trial name
- NCT04035564
- Testing
- Sodium < 1mEq/kg/day, Sodium 5mEq/kg/day
- Where
- Mexico
- Volunteers
- 52 people
- Sponsor
- Hospital del Niño "Dr. Federico Gomez Santos"
Pregnancy Complications
Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm…
- Trial name
- NCT01050647
- Testing
- 17-Hydroxyprogesterone Caproate, Caster Oil injections
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Stanford University
Premature Birth, Decision Making
Preemie Prep For Parents (P3): Home Antenatal Prematurity Education
The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners.
- Conditions
- Premature Birth, Decision Making, Prenatal Care, Resuscitation
- Trial name
- NCT04093492
- Testing
- Preemie Prep for Parents (P3) Outpatient Mobile Intervention, ACOG links
- Where
- United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Preterm Delivery
Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)
The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will: 1.
- Trial name
- 17PinPROM (NCT01119963)
- Testing
- 17-alpha-hydroxy-progesterone caproate, Makena®
- Where
- 15 sites in United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
Prematurity; Extreme, Feeding Disorder Neonatal
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z…
- Conditions
- Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure
- Trial name
- NCT04325308
- Testing
- Protein-enriched human milk diet, Usual human milk diet
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Preterm Birth, Health Care Utilization
Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before…
- Conditions
- Preterm Birth, Health Care Utilization, Tobacco Use, Contraceptive Usage
- Trial name
- NCT05120843
- Testing
- Care coordination and motivational interviewing
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Extremely Low Gestational Age Newborn, Premature Infant
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants.
- Trial name
- NCT01536093
- Testing
- oropharyngeal administration of own mother's colostrum, oropharyngeal administration of sterile water
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Bronchopulmonary Dysplasia (BPD)
Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial
This is a phase I/II open-label study to determine the lowest, safe, effective dose of budesonide given with calfactant as the vehicle.
- Trial name
- SASSIE (NCT02907593)
- Testing
- Budesonide in Calfactant
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Cynthia McEvoy
Premature Birth
Neonatal Pulse Oximetry Sensor Study
To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.
- Trial name
- NCT05250102
- Testing
- Pulse oximeter sensors
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Medline Industries
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
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
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given mask CPAP/PPV with an FiO2 of 1.0 during…
- Conditions
- IVH- Intraventricular Hemorrhage, Extreme Prematurity, Hypoxia Neonatal, Hyperoxia
- Trial name
- DOXIE (NCT04413097)
- Testing
- Delayed Cord Clamping with Low Oxygen concentration, Delayed Cord Clamping with High Oxygen concentration
- Where
- 3 sites in United States
- Volunteers
- 140 people
- Sponsor
- Sharp HealthCare
Preterm Birth
Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart pacemaker to deliver a weak electrical current to the human uterus that will rapidly and safely inhibit the unwanted premature uterine…
- Trial name
- NCT00212446
- Testing
- Electrical Intervention (EI)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- St. Luke's-Roosevelt Hospital Center
Premature Birth
Feeding and Transition to Home for Preterms at Social Risk
Premature infants are at high risk of suboptimal health and development. This randomized clinical trial evaluated the impact of a developmentally based intervention, H-HOPE (Hospital-home transition: optimizing prematures'…
- Trial name
- H-HOPE (NCT02041923)
- Testing
- H-HOPE, Attention Control
- Where
- 2 sites in United States
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago