Status:
COMPLETED
Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury
Lead Sponsor:
Hong Huang
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Intraventricular Hemorrhage
Periventricular Leukomalacia
Eligibility:
All Genders
24-30 years
Phase:
PHASE1
PHASE2
Brief Summary
Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions that commonly occur in preterm infants and are well-recognized major contributors to long-term brain injury a...
Detailed Description
The investigators will compare efficacy and safety of prophylactic indomethacin, DCC, and their combination, in affecting the incidence and severity of IVH/PVL in infants \<30wks gestational age (prim...
Eligibility Criteria
Inclusion
- pregnant women admitted \>24weeks and \<30weeks gestational age,
- in-hospital birth (allowing for cord clamp randomization)
Exclusion
- preterm infant \<24weeks or \>30weeks at birth
- maternal risks identified by obstetrician
- fetal risks identified by obstetrician
- any congenital abnormality of newborn infant
- placental abruption/placental previa
- delivery less than 2hrs from consenting to study participation
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2021
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT02221219
Start Date
August 1 2014
End Date
August 28 2021
Last Update
November 23 2021
Active Locations (1)
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1
Kentucky Childrens Hospital Neonatal Intensive Care Unit
Lexington, Kentucky, United States, 40506