Clinical trials: Preterm Delivery
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
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
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
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
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
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
Very Preterm Maturity of Infant, The Risk Factors for Improving the Prognosis of VLBW Infants
Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
To study and analyze the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life (less than 3 days of life) among the very low birth weight (VLBW) infants.
- Trial name
- NCT05949788
- Testing
- No intervention
- Where
- China
- Volunteers
- 146 people
- Sponsor
- Shenzhen Bao'an Maternal and Child Health Hospital
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 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
Retinopathy of Prematurity (ROP)
Rainbow Extension Study
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study…
- Trial name
- RainbowExt (NCT02640664)
- Testing
- Ranibizumab
- Where
- 73 sites in United States, Austria and 22 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
Premature Infants
A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not increase rates of respiratory-related re-hospitalizations and ED visits, and will not impair growth compared to standard oxygen management…
- Trial name
- NCT01994954
- Testing
- RHO
- Where
- 8 sites in United States
- Volunteers
- 196 people
- Sponsor
- University of Massachusetts, Worcester
Preterm Delivery, Cervical Length
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the…
- Trial name
- SCAN (NCT00439374)
- Testing
- 17 alpha-hydroxyprogesterone caproate
- Where
- 14 sites in United States
- Volunteers
- 657 people, healthy volunteers welcome
- Sponsor
- The George Washington University Biostatistics Center