Clinical trials: Intraventricular Hemorrhage of Prematurity
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants…
- Conditions
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)
- Trial name
- NCT03253263
- Testing
- OHB-607
- Where
- 62 sites in United States, Australia and 11 more
- Volunteers
- 295 people
- Sponsor
- OHB Neonatology Ltd.
Premature Infants
Urine Concentration of S100B in Extremely Premature Infants
S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS) and is increased in CSF and blood after CNS injury. There are two objectives to this study.
- Trial name
- NCT00747591
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of Utah
Intraventricular Hemorrhage of Prematurity
Research on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants
1. Establish a reference curve for the lateral ventricular diameter of premature infants and determine the intervention threshold for hydrocephalus after hemorrhage in premature infants based on the reference curve, providing a…
- Trial name
- ROPEDACEOIHIPI (NCT07157020)
- Testing
- ommaya capsule implantation technique
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Prematurity; Extreme, Cerebral Circulatory Failure
Sonographic QUantification of Venous Circulation In the Preterm Brain
The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an…
- Conditions
- Prematurity; Extreme, Cerebral Circulatory Failure, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Trial name
- SQUIB (NCT04535375)
- Testing
- Doppler Ultrasound of venous cerebral circulation
- Where
- Belgium
- Volunteers
- 47 people
- Sponsor
- Universitair Ziekenhuis Brussel
Intraventricular Hemorrhage Neonatal, Post-hemorrhagic Hydrocephalus
Advanced MRI in IVH
55,000 babies are born prematurely in the UK annually. Bleeding in the fluid spaces of the brain (ventricles) is common after prematurity; in England around 450 babies suffer from severe bleeds every year.
- Trial name
- NCT07412886
- Testing
- Advanced MRI
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Bronchopulmonary Dysplasia, Necrotizing Enterocolitis
Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
- Conditions
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis
- Trial name
- NCT00840983
- Testing
- delayed cord clamping
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Rhode Island
Hypothermia, Anemia
Delayed Cord Clamping in Premature Infants
Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold.
- Trial name
- NCT01018576
- Testing
- Delayed cord clamping
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of California, Davis
Intraventricular Hemorrhage, Hydrocephalus
Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants
Intraventricular hemorrhage remains the most frequent, severe neurological complication of prematurity, occurring in 25-30% of preterm infants.
- Trial name
- LETAP (NCT00875758)
- Testing
- Removal of CSF through ventricular access device, Removal of CSF through a ventricular access device
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Washington University School of Medicine
Intraventricular Hemorrhage of Prematurity
Tortle Midliner and Intraventricular Hemorrhage
The purpose of the study is to determine if early application of the Tortle Midliner for preterm infants, ≤ 3 hours following birth and with subsequent continuous use through 72 hrs.
- Trial name
- IVH (NCT03543046)
- Testing
- Tortle Midliner
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Orlando Health, Inc.
Infant, Very Low Birth Weight, Infant, Premature
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)
This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy or developmental problems at 18 to 22…
- Conditions
- Infant, Very Low Birth Weight, Infant, Premature, Ductus Arteriosus, Patent
- Trial name
- TIPP (NCT00009646)
- Testing
- indomethacin
- Where
- 9 sites in United States
- Volunteers
- 1,202 people
- Sponsor
- NICHD Neonatal Research Network
Hemorrhage, Premature Infants
NIRS Monitoring in Premature Infants
This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for…
- Conditions
- Hemorrhage, Premature Infants, Newborn, Hydrocephalus
- Trial name
- NCT02601339
- Testing
- ETV/CPC
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Neonatal Cerebral Leukomalacia, Intracranial Nontraumatic Haemorrhage of Fetus and Newborn
The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants
This study determines the effectiveness of cerebral Near Infrared Spectroscopy (NIRS) as a monitoring device combined with a SafeboosC treatment guideline in order to prevent brain injury in very low birth weight preterm…
- Conditions
- Neonatal Cerebral Leukomalacia, Intracranial Nontraumatic Haemorrhage of Fetus and Newborn, Neonatal Mortality
- Trial name
- NCT06729398
- Testing
- NIRS, SafeboosC
- Where
- Indonesia
- Volunteers
- 129 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Preterm Birth
Preterm Infant Transport Stress (PremiTranS) Study
This is an observational pilot study to quantify the amount of vibration, noise, physiological and biochemical instability that premature babies are exposed to during inter-hospital transport.
- Trial name
- PremiTranS (NCT01851668)
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- University of Nottingham
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Delayed Umbilical Cord Clamping Benefits, Postpartum Haemorrhage
Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.
Early cord clamping after delivery has been common practice for many decades as part of the active management of the third stage of labour.
- Conditions
- Delayed Umbilical Cord Clamping Benefits, Postpartum Haemorrhage, Intraventricular Haemorrhage
- Trial name
- CODE-P (NCT02187874)
- Testing
- delayed umbilical cord occlusion, early umbilical cord occlusion, Oxytocin
- Where
- Spain
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Infant, Newborn, Infant, Small for Gestational Age
Vitamin E for Extremely Preterm Infants
The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and less than 1000 grams birth…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01193270
- Testing
- Vitamin E
- Where
- 16 sites in United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Intraventricular Hemorrhage, Sepsis
Placental Transfusion Project for Preterm Infants
The American College of Obstetrics and Gynecology, American Academy of Pediatrics and the World Health Organization have recently published recommendations related to placental transfusions in preterm infants.
- Conditions
- Intraventricular Hemorrhage, Sepsis, Necrotizing Enterocolitis
- Trial name
- NCT02400697
- Testing
- <30 wks gestation or 1500 grams
- Where
- United States
- Volunteers
- 2,856 people
- Sponsor
- Indiana University
Fetal Membranes, Premature Rupture, Premature Birth
The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
Cranberries have been proved to reduce the rate of urinary tract infections in a population of women with recurrent urinary tract infections in previous studies.
- Trial name
- NCT00247104
- Testing
- Cranberries - Vaccinium macrocarpon
- Where
- Israel
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.
- Conditions
- Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage, Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
- Trial name
- NCT04506619
- Testing
- No Intervention
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 26 people
- Sponsor
- Oak Hill Bio Ltd
Infant, Premature, Leukomalacia, Periventricular
Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants
Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in preterm infants. Inflammation, hypoxia-ischemia, free oxygen radical formation and excitotoxicity are all known pathogenic mechanisms that…
- Conditions
- Infant, Premature, Leukomalacia, Periventricular, Intraventricular Hemorrhage, Retinopathy of Prematurity
- Trial name
- NCT00910234
- Testing
- recombinant human erythropoietin (rhEpo), Normal saline
- Where
- Taiwan
- Volunteers
- 100 people
- Sponsor
- China Medical University Hospital