Clinical trials: Premature Labor
Serious Systemic Infections, Necrotizing Enterocolitis
Metronidazole Pharmacokinetics (PK) in Premature Infants
Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis.
- Trial name
- PTN_METRO (NCT01222585)
- Testing
- Metronidazole
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Michael Cohen-Wolkowiez
Infant, Premature, Premature Birth
Comparing IM vs. Vaginal Progesterone for Pre-term Birth
This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm…
- Trial name
- NCT00579553
- Testing
- Intramuscular Progesterone, Vaginal Progesterone
- Where
- United States
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
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
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
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
Prematurity
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.
- Trial name
- NCT01860573
- Testing
- Amino acids
- Where
- United States
- Volunteers
- 168 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Premature Infant Disease, Family Research
PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU).
- Conditions
- Premature Infant Disease, Family Research, Parent-Child Relations, Self Efficacy
- Trial name
- NCT04638127
- Testing
- PREEMIE PROGRESS, Attention Control
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati
Preterm Infant
Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
Every year, almost all of ½ million infants born prematurely in the US and 15 million worldwide suffer from abnormal brain maturation resulting from interactions between immaturity and atypical sensory experiences after birth.
- Trial name
- NCT03232931
- Testing
- Therapist skin-to-skin Care, Contingent parent's voice exposure, Parental skin-to-skin care
- Where
- 3 sites in United States
- Volunteers
- 248 people
- Sponsor
- Emory University
Obstetric Labor, Premature
Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor
The purpose of this research study is to determine the best medication to stop preterm labor. Recent studies have identify nifedipine and indomethacin as the two medications that are most likely to delay delivery for 48 hours…
- Trial name
- NCT03129945
- Testing
- Nifedipine, Indomethacin
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- University of California, Irvine
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
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
Respiratory Distress Syndrome
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
- Trial name
- NCT00807235
- Testing
- Aerosolized lucinactant
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Windtree Therapeutics
Premature Infants, Stool Bacterial Composition
Effects of Probiotic and Prebiotic Combinations on Premature Infants
The purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants.
- Conditions
- Premature Infants, Stool Bacterial Composition, Growth
- Trial name
- NCT00282113
- Testing
- ProBioPlus, Culturelle
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
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
Pregnancy
Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women
This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term pregnant patients.
- Trial name
- NCT01399229
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reproductive Research Technologies, LP
Transient Tachypnea of the Newborn
Fluid Management in Transient Tachypnea of the Newborn
Transient tachypnea of the newborn (TTN) is a diagnosis given to infants born between 34 and 42 weeks gestation who develop difficulty breathing during the first days of life when no specific cause of the breathing difficulty can…
- Trial name
- NCT01225029
- Testing
- Amount of total fluids
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
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
Infant,Premature
Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI)
The purpose of this research is to determine the effect of premature birth on later heart function and metabolism.
- Trial name
- PET-MRI (NCT03245723)
- Testing
- Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Necrotizing Enterocolitis
Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs).
- Trial name
- steroids/NEC (NCT01156480)
- Testing
- hydrocortisone
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Endeavor Health