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Clinical Trials/NCT03681314
NCT03681314
Withdrawn
Not Applicable

Long-term Outcomes of Umbilical Cord Milking in Term and Late Preterm Neonates Who Are Depressed at Birth

Nemours Children's Clinic3 sites in 1 countryOctober 17, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypoxic-Ischemic Encephalopathy
Sponsor
Nemours Children's Clinic
Locations
3
Primary Endpoint
Neurodevelopmental Outcome at 2 Years of Age
Status
Withdrawn
Last Updated
3 years ago

Overview

Brief Summary

An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).

Detailed Description

The MIDAB-Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were depressed at birth and enrolled in MIDAB trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ICC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.

Registry
clinicaltrials.gov
Start Date
October 17, 2022
End Date
August 16, 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zubair Aghai

Professor of Pediatrics

Nemours Children's Clinic

Eligibility Criteria

Inclusion Criteria

  • Enrolled in MIDAB trial

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Neurodevelopmental Outcome at 2 Years of Age

Time Frame: 22-26 months

Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire

Secondary Outcomes

  • Fidgety Movements at 3 months of age(3-5 months)
  • Neurodevelopmental Outcome at 1 Year of Age(10-14 months)
  • Autism Outcome(22-26 months)

Study Sites (3)

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