A Cluster Randomized Clinical Trial of Umbilical Cord Milking Versus Early Cord Clamping on Short and Long-term Outcomes in Neonates Who Are Non-Vigorous at Birth
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Sponsor
- Nemours Children's Clinic
- Enrollment
- 3442
- Locations
- 9
- Primary Endpoint
- Neurodevelopmental Outcome at 2 Years of Age
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking (UCM) or early cord clamping (ECC).
Detailed Description
The CORDMILK Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were non-vigorous at birth and enrolled in the CORDMILK trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ECC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.
Investigators
Zubair Aghai
Professor of Pediatrics
Nemours Children's Clinic
Eligibility Criteria
Inclusion Criteria
- •Enrolled in CORDMILK trial
- •Non-vigorous at birth
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Neurodevelopmental Outcome at 2 Years of Age
Time Frame: 22-26 months
Neurodevelopmental assessment will be performed by the trained and experienced examiner who will be blinded to the interventions. Severe neurodevelopmental impairment will be defined having at least one of the following: BSID (IV) composite cognitive score \<70, GMFCS level 3-5, blindness (vision \<20/200), or hearing impairment requiring hearing aids/cochlear implant. Moderate neurodevelopmental impairment will be defined as having a cognitive composite score 70-84, GMFCS level 2, unilateral blindness (vision/20/200 in only one eye), or hearing impairment with no amplification/cochlear implant.
Secondary Outcomes
- Neurodevelopmental Outcome at 1 Year of Age(10-14 months)