Status:
UNKNOWN
Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)
Lead Sponsor:
Sharp HealthCare
Collaborating Sponsors:
Sharp Mary Birch Hospital for Women & Newborns
Loma Linda University
Conditions:
Neurodevelopmental Abnormality
Eligibility:
All Genders
22-42 years
Phase:
NA
Brief Summary
An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. This prospective...
Detailed Description
The PREMOD2 Follow-up trial will examine the difference in early childhood neurodevelopmental outcomes of subjects enrolled in the PREMOD2 umbilical cord milking (UCM) vs. delayed cord clamping (DCC) ...
Eligibility Criteria
Inclusion
- Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.
Exclusion
- Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.
Key Trial Info
Start Date :
July 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03476980
Start Date
July 6 2019
End Date
December 1 2024
Last Update
November 25 2022
Active Locations (18)
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1
University of Alabama
Birmingham, Alabama, United States, 35294-0004
2
Loma Linda Medical Center
Loma Linda, California, United States, 92350
3
LAC+USC Medical Center
Los Angeles, California, United States, 90033
4
PIH Health Good Samaritan Hospital
Los Angeles, California, United States, 90033