Clinical trials: Obstetric; Injury
Bronchopulmonary Dysplasia, Encephalomalacia
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.
- Conditions
- Bronchopulmonary Dysplasia, Encephalomalacia, Premature Birth
- Trial name
- NCT00167544
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Nationwide Children's Hospital
Premature Infants, Very Premature Infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Trial name
- AP2 (NCT07254000)
- Testing
- Anakinra (Kineret®)
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 24 people
- Sponsor
- Monash Medical Centre
Preterm Infant
The Effects of Mother-infant Skin-to-skin Contact on Stress Response of Preterm Infants
This study will evaluate the effect of maternal-infant skin-to-skin contact (SSC) versus routine care on general stress in preterm infants in the neonatal intensive care unit (NICU).
- Trial name
- NCT05503238
- Testing
- Skin-to-skin contact, Routine care
- Where
- China
- Sponsor
- Children's Hospital of Fudan University
Brain Injuries, Infant, Premature
SafeBoosC - a Phase II Trial
Background 25,000 infants are born extremely preterm every year in Europe. This group of infants carries a high risk of death and subsequent cerebral impairment for the infant, especially in the first 72 hours of life.
- Trial name
- SafeBoosC (NCT01590316)
- Testing
- Cerebral NIRS oximetry
- Where
- Denmark
- Volunteers
- 165 people
- Sponsor
- Gorm Greisen
Bronchopulmonary Dysplasia
Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants
At present, widespread use of the human milk-based caloric supplement (cream) has not occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are needed to support its adoption as a standard care…
- Trial name
- NCT02475434
- Testing
- Cream Supplement group
- Where
- 8 sites in United States, Austria
- Volunteers
- 210 people
- Sponsor
- Baylor College of Medicine
Septum; Uterus, Rupture, Uterine
Uterine Rupture After Hysteroscopic Septum Resection
To date, several studies have already confirmed a positive effect of hysteroscopic metroplasty on reproductive outcomes in primary infertile women affected by uterine septum, the most common uterine malformation.
- Trial name
- NCT04449640
- Testing
- Hysteroscopic septum resection.
- Where
- Italy
- Volunteers
- 3,000 people
- Sponsor
- Università degli Studi dell'Insubria
Pregnancy Related, Pelvic Floor Disorders
Perineal Massage Using A Pelvic Wand During Pregnancy
There is limited research on the optimal strategy to reduce obstetric laceration, postpartum urinary retention, and postpartum pelvic pain.
- Conditions
- Pregnancy Related, Pelvic Floor Disorders, Obstetric; Injury, Patient Empowerment
- Trial name
- NCT06986824
- Testing
- Pelvic wand
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Beth Israel Deaconess Medical Center
Respiratory Distress Syndrome, Chronic Lung Disease of Prematurity
Prevention of Chronic Lung Disease (CLD) in Preterm Infants
Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success.
- Trial name
- NCT00883532
- Testing
- budesonide
- Where
- China
- Volunteers
- 300 people
- Sponsor
- China Medical University, China
Uterine Rupture Gravid
Uterine Rupture International Data Acquisition
Uterine rupture represents an uncommon event: it is is a life-threatening obstetric complication with high maternal and perinatal morbidity and mortality.
- Trial name
- URIDA (NCT03576950)
- Volunteers
- 100 people
- Sponsor
- Università degli Studi dell'Insubria
Premature Birth, Respiratory Distress Syndrome
Non-invasive Ventilation in Preterm Infants
This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional.
- Conditions
- Premature Birth, Respiratory Distress Syndrome, Ventilator Lung; Newborn
- Trial name
- NCT05987800
- Testing
- Titration procedure, Electrical impedance tomography, Lung and diaphragm ultrasound
- Where
- Belgium
- Volunteers
- 136 people
- Sponsor
- Universitair Ziekenhuis Brussel
Metabolic Bone Disease, Osteopenia
A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method
The goal of this project is to develop a new noninvasive ultrasound based technique, called vibro-acoustic analysis (VAA), for evaluation of infant bone health with particular application in assessment of bone health in premature…
- Conditions
- Metabolic Bone Disease, Osteopenia, Neonatal Rickets
- Trial name
- NCT04752098
- Testing
- Vibro-acoustic analysis (VAA), based on ultrasound radiation force
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Mayo Clinic
Bronchopulmonary Dysplasia
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube).
- Trial name
- NCT01440647
- Testing
- Extubation to NIPPV, Extubation to CPAP
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Infant, Newborn, Infant, Low Birth Weight
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Surfactant 1 (NCT01203358)
- Testing
- Exosurf, Survanta
- Where
- 13 sites in United States
- Volunteers
- 617 people
- Sponsor
- NICHD Neonatal Research Network
Obstetric Trauma, Infections
Oral Antibiotics After Obstetric Perineal Tear
The purpose of this study is to investigate if 3 dose of oral antibiotics administrated the first day after a vaginal delivery with a second degree obstetric tear will decrease the risk of infection and/or wound dehiscence…
- Conditions
- Obstetric Trauma, Infections, Wound Dehiscence
- Trial name
- REPAIR (NCT05830162)
- Testing
- Bioclavid (Amoxicillin and Clavulanic acid)
- Where
- Denmark
- Volunteers
- 442 people
- Sponsor
- Hanna Jangö
Infant, Newborn, Infant, Low Birth Weight
Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Phenobarbital (NCT00009620)
- Testing
- Phenobarbital, Saline
- Where
- 11 sites in United States
- Volunteers
- 610 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Perineal Tear, Obstetric Trauma
Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture
Anovaginal distance measured by palpation and perineal ultrasound are similar.
- Trial name
- AVD and OASR (NCT03039582)
- Testing
- Bidigital palpation, Perineal ultrasound
- Volunteers
- 151 people
- Sponsor
- Ostergotland County Council, Sweden
Bronchopulmonary Dysplasia, Respiratory Tract Infections
Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Tract Infections, Premature Birth of Newborn
- Trial name
- NCT02023788
- Testing
- PNEUMOSTEM
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Medipost Co Ltd.
Preterm Birth, Premature Birth
Exposure to Plasticisers in the Neonatal Intensive Care Unit
Neonatal intensive care relies on indwelling plastic medical devices fundamental in respiratory support, intravenous catheterization, and nutrition.
- Conditions
- Preterm Birth, Premature Birth, Neurodevelopmental Disorders, Pulmonary Disease
- Trial name
- PLASTIC-NICU (NCT05404815)
- Where
- Belgium
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
Pregnancy Related, Trauma
The Use of Fetal Fibronectin to Predict Delivery Due to Abruptio Placenta
The purpose of this study is to determine if the presence of fetal fibronectin in the cervicovaginal secretions of pregnant patients with minor maternal trauma predicts impending preterm delivery due to abruptio placenta.
- Conditions
- Pregnancy Related, Trauma, Abruptio Placentae
- Trial name
- NCT01279369
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Winthrop University Hospital
Bronchopulmonary Dysplasia
Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease
This is a prospective, longitudinal observational study to provide data regarding the natural course of hypercapnia in premature infants with bronchopulmonary dysplasia using both available blood pCO2 and measured capnography, as…
- Trial name
- NCT02996162
- Testing
- Massimo Root Monitoring System, ISA-Infrared Sidestream Gas Analyzer
- Where
- United States
- Sponsor
- Boston Children's Hospital