Clinical trials: Intraventricular Hemorrhage Neonatal
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
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
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
Intraventricular Brain Hemorrhage
Detection and Quantification of Neonatal Intraventricular Hemorrhage
Dense array EEG and EIT (electrical impedence tomography) are new technologies that can add to information needed to diagnose neurological problems in infants - both preterm and term.
- Trial name
- DQNIH (NCT01899651)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Electrical Geodesics, Inc.
Premature Birth, Mortality
Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow Up Study
A specified version of the Apgar-Score, that can be used in newborns under resuscitation, was developed and its value to predict chronic damage in preterm infants will be tested.
- Conditions
- Premature Birth, Mortality, Apgar Score
- Trial name
- NCT01186627
- Where
- Germany
- Volunteers
- 1,500 people
- Sponsor
- Technische Universität Dresden
Intraventricular Hemorrhage, Autoregulation
Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage
Annually, almost 5,000 extremely low birth weight (9 ounces to about 2 lbs) infants born in the US survive with severe bleeding in the brain (intraventricular hemorrhage); this devastating complication of prematurity is…
- Trial name
- PhysDis (NCT00665769)
- Testing
- Hypercapnia, Normocapnia
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Baylor College of Medicine
Intraventricular Hemorrhage, Premature Birth
Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants
Babies born very prematurely are at risk of intraventricular hemorrhage (IVH), which is bleeding in or around the fluid-filled spaces of the brain. Most IVH occurs during the first week after birth.
- Trial name
- iF-MOM-IVH (NCT07812922)
- Testing
- Intranasal Fresh Mother's Own Milk (iF-MOM)
- Volunteers
- 67 people
- Sponsor
- University of Manitoba
Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia
Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill
There have been many studies on the use of running training in older children to improve gait development in children with cerebral palsy.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage Neonatal, Bilirubin Encephalopathy
- Trial name
- NCT03534466
- Testing
- Baby treadmill, Conventional physical rehabilitation training
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Children's Hospital of Fudan University
Brain Injuries, Congenital Heart Disease
Protecting Brains and Saving Futures - the PBSF Protocol
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care.
- Conditions
- Brain Injuries, Congenital Heart Disease, Newborn Morbidity, Intraventricular Hemorrhage
- Trial name
- PBSF (NCT03786497)
- Where
- 2 sites in Brazil
- Volunteers
- 2,268 people
- Sponsor
- Protecting Brains Saving Futures
Hypothermia
Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room
The purpose of this research project is to ascertain the effectiveness of plastic head covering in prevention of hypothermia. Hypothermia is defined by body temperature <36.5º Celsius by the World Health Organization.
- Trial name
- NCT00904228
- Testing
- placement of plastic cap during delivery room stabilization, placement of routine cap during delivery room stabilization
- Where
- United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Intraventricular Hemorrhage, Spina Bifida
Micro Ribonucleic Acid (miRNA) Markers of Hydrocephalus in Intraventricular Hemorrhage (IVH)
A collection of biological samples (cerebrospinal fluid [CSF] and blood) from patients under 6 years of age who are diagnosed with intraventricular hemorrhage or spina bifida.
- Trial name
- NCT02386228
- Testing
- collection of CSF and blood
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
The Correlation Between Red Cell Transfusion and Complications of Prematurity
The aim of this clinical trial is to learn if there is a correlation between the erythrocyte transfusion in the early neonatal period in premature infants and early and late complications of prematurity.
- Conditions
- Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD), Enterocolitis, Necrotizing, Intraventricular Hemorrhage Neonatal
- Trial name
- NCT07123948
- Testing
- Wechsler Intelligence Test, performed by educated psychologists
- Where
- Croatia
- Volunteers
- 128 people
- Sponsor
- Clinical Hospital Center Rijeka
Respiratory Distress Syndrome In Premature Infants
Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates
The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive…
- Trial name
- NCT02445040
- Testing
- Babylog VN500 in HFOV Mode
- Where
- 14 sites in United States
- Volunteers
- 225 people
- Sponsor
- Draeger Medical Systems, Inc.
Preterm Birth Complication, Neonatal Morbidity and Mortality
Delayed Versus Immediate Cord Clamping in Preterm Birth
The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.
- Conditions
- Preterm Birth Complication, Neonatal Morbidity and Mortality, Cord Clamping, Delayed Cord Clamping
- Trial name
- PREM-CORD (NCT07699666)
- Testing
- Delayed Umbilical Cord Clamping, Immediate Umbilical Cord Clamping
- Where
- Tunisia
- Volunteers
- 200 people
- Sponsor
- Faculty of Medicine of Tunis
Hypotension and Shock, Hypoperfusion
Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates
Study type: Prospective Observational trial Study design: Longitudinal Population: Preterm newborns <32 weeks gestational age Hypothesis: The inclusion of non-invasive physiological measures of cardiac output, peripheral…
- Conditions
- Hypotension and Shock, Hypoperfusion, Hemodynamic Instability, Intraventricular Hemorrhage
- Trial name
- NOAH (NCT04538079)
- Testing
- Multimodal objective non-invasive Monitoring
- Where
- Ireland
- Volunteers
- 56 people
- Sponsor
- University College Cork
Extreme Prematurity, Intraventricular Hemorrhage
Single-dose Prophylactic INdomethacin in Extremely Preterm Infants
In Canada, about 900 babies each year are born very early (<26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain.
- Conditions
- Extreme Prematurity, Intraventricular Hemorrhage, Morbidity;Newborn
- Trial name
- SPIN (NCT06572917)
- Testing
- Indomethacin
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 500 people
- Sponsor
- University of British Columbia
Hypotension, Low Blood Pressure
Management of Hypotension In the Preterm Infant
The HIP trial is a large pragmatic, multinational, randomised trial of two different strategies for the management of hypotension in extremely low gestational age newborns (Standard with dopamine versus a restricted with placebo…
- Conditions
- Hypotension, Low Blood Pressure, Intraventricular Hemorrhage of Prematurity
- Trial name
- HIP (NCT01482559)
- Testing
- Dopamine hydrochloride, Dextrose 5%
- Where
- 10 sites in Belgium, Canada and 3 more
- Volunteers
- 58 people
- Sponsor
- University College Cork
Motor Delay, Premature Birth
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials.
- Conditions
- Motor Delay, Premature Birth, Intraventricular Hemorrhage, Hypoxic-Ischemic Encephalopathy
- Trial name
- NCT05568264
- Testing
- Physical Therapy intervention
- Where
- 3 sites in United States
- Volunteers
- 222 people
- Sponsor
- Shirley Ryan AbilityLab
Intraventricular Hemorrhage
Neonatal Resuscitation With Intact Cord
The purpose of this study is to examine whether providing ventilation during delayed umbilical cord clamping provides greater placental transfusion and improved hemodynamic transition at birth.
- Trial name
- NRIC (NCT02231411)
- Testing
- V-DCC, Delayed cord clamping, Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Sharp HealthCare
Intraventricular Hemorrhage of Prematurity, Hydrocephalus
Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
The primary purpose of this study is to serve as a pilot study of the EFIL device treatment feasibility of IVH grades 3,4 to guide development of a larger trial.
- Trial name
- EFIL (NCT06797219)
- Testing
- Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Rutgers, The State University of New Jersey