Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping) (PREMOD2FU)
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- STATUS
- Recruiting
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- End date
- Jun 23, 2024
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- participants needed
- 1200
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- sponsor
- Sharp HealthCare
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 multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
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) trial, using standardized neurologic and developmental assessments at 22-26 months corrected age (CA). The corrected age may be extended out to 42 months CA due to Covid-19 pandemic for undetermined period of time.
Details
| Condition | Neurodevelopmental Abnormality |
|---|---|
| Treatment | Randomized to Umbilical Cord Milking at birth, Randomized to Delayed Cord Clamping at birth |
| Clinical Study Identifier | NCT03476980 |
| Sponsor | Sharp HealthCare |
| Last Modified on | 23 April 2022 |
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