Clinical trials: Prematurity
PPROM, Respiratory Distress Syndrome in Premature Infants
Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care…
- Trial name
- NCT02939742
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Ventricular Tachycardia, Premature Ventricular Contraction
DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation
The purpose of this study is to learn if taking a drug called direct oral anticoagulant after an ablation procedure keeps blood clots from forming and lowers the chance of having a stroke in patients with ventricular tachycardia…
- Conditions
- Ventricular Tachycardia, Premature Ventricular Contraction, Stroke
- Trial name
- STROKE-VT (NCT02666742)
- Testing
- DOAC, Aspirin
- Where
- 5 sites in United States, India
- Volunteers
- 246 people
- Sponsor
- Kansas City Heart Rhythm Institute
Bronchopulmonary Dysplasia, Neurally Adjusted Ventilatory Assist
NAVA vs. CMV Crossover in Severe BPD
This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered…
- Conditions
- Bronchopulmonary Dysplasia, Neurally Adjusted Ventilatory Assist, Mechanical Ventilation
- Trial name
- NCT04821453
- Testing
- NAVA, CMV
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Children's Hospital of Philadelphia
Obstetric Labour, Premature
A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
The study's primary objective is to demonstrate the superiority of retosiban to prolong pregnancy and improve neonatal outcomes compared with placebo.
- Trial name
- NEWBORN-1 (NCT02377466)
- Testing
- Retosiban IV infusion
- Where
- 50 sites in United States, Canada and 3 more
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Preterm Labour
Are Uterine Natural Killer Cells Involved in the Initiation of Preterm Labor ?
Research question: Population of study: women diagnosed as term pregnancy in labor (control) and the other group diagnosed as preterm labor (cases). Intervention: measuring uterine natural killer cells .
- Trial name
- NCT02284867
- Testing
- immunohistochemistry study
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Bronchopulmonary Dysplasia
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
- Trial name
- NCT03857841
- Testing
- UNEX-42, Phosphate-buffered saline
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- United Therapeutics
Muscular Dystrophy, Duchenne, Muscular Dystrophies
An Extension Study of Ataluren (PTC124) in Participants With Nonsense Mutation Dystrophinopathy
The primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous Phase 3 study of ataluren…
- Conditions
- Muscular Dystrophy, Duchenne, Muscular Dystrophies, Muscular Disorders, Atrophic, Muscular Diseases
- Trial name
- NCT02090959
- Testing
- Ataluren
- Where
- 58 sites in United States, Australia and 17 more
- Volunteers
- 219 people
- Sponsor
- PTC Therapeutics
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
Preterm Birth, Short Cervix
Prevention of Preterm Birth With a Pessary in Singleton Gestations
Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually.
- Trial name
- PoPPS (NCT02056652)
- Testing
- Bioteque cup pessary
- Where
- 4 sites in United States
- Volunteers
- 122 people
- Sponsor
- University of Pennsylvania
Total Parenteral Nutrition-induced Cholestasis, Cholestasis
Compassionate Use of Omegaven in Children
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
- Conditions
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis
- Trial name
- NCT02370251
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Oklahoma
Infant,Premature, Bronchopulmonary Dysplasia
L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects up to 35% of very low birth weight infants (VLBW < 1500 g).
- Conditions
- Infant,Premature, Bronchopulmonary Dysplasia, Pulmonary Hypertension
- Trial name
- NCT03542812
- Testing
- L-Citrulline
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Utah
Premature Birth of Newborn, Family
GPS (Giving Parents Support): Parent Navigation After NICU Discharge
BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge.
- Conditions
- Premature Birth of Newborn, Family, Immature Newborn, Newborn Morbidity
- Trial name
- GPS (NCT02643472)
- Testing
- Parent Navigator, Care Notebook
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Children's National Research Institute
HIV Infection, Vaginal Atrophy
Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
During menopause, there is a decrease in a hormone estrogen, which leads to aging of the vagina. Vaginal aging includes changes in the type and amount of healthy bacteria in the vagina, inflammation and a breakdown of natural…
- Conditions
- HIV Infection, Vaginal Atrophy, Menopause, Menopause Related Conditions
- Trial name
- NCT04079218
- Testing
- Estradiol Vaginal Insert
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Kerry Murphy
Premature Birth, Brain Injury
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may reduce this risk. The unborn baby receives melatonin from the mother but following premature delivery there maybe a period of prolonged…
- Trial name
- MIND (NCT00649961)
- Testing
- Melatonin injection
- Where
- 2 sites in United Kingdom
- Volunteers
- 18 people
- Sponsor
- Imperial College London
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
Respiratory Illness
NICU Asthma Education and Secondhand Smoke Reduction Study
Premature infants have a significantly increased risk for developing respiratory illnesses and asthma. Secondhand smoke (SHS) also is clearly associated with increased breathing problems in children, thus exposure to smoke makes…
- Trial name
- NCT00499915
- Testing
- Secondhand Smoke Reduction and Smoking Cessation Counseling, Asthma Education
- Where
- United States
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- University of Rochester
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"
Inguinal Hernia
Awake Caudal Catheter vs General Anesthesia
It is well established that preterm inguinal hernias discovered in the NICU pose a significant surgical risk due to the associated co-morbid conditions that accompany these patients.
- Trial name
- NCT05919732
- Testing
- Bupivacaine, Dexmedetomidine, Caffeine, Tylenol, Propofol, rocuronium, caffeine, Tylenol, bupivacaine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Nemours Children's Clinic
Infant, Newborn, Infant, Small for Gestational Age
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
- Trial name
- NCT01534481
- Testing
- Donor Milk, Preterm Formula
- Where
- 17 sites in United States
- Volunteers
- 483 people
- Sponsor
- NICHD Neonatal Research Network