Two Year Developmental Follow-up for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Neurodevelopmental Abnormality
- Sponsor
- Sharp HealthCare
- Enrollment
- 1200
- Locations
- 18
- Primary Endpoint
- Developmental Outcome
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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 multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
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) 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.
Exclusion Criteria
- •Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.
Outcomes
Primary Outcomes
Developmental Outcome
Time Frame: 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.
Bayley Scales of Infant Development (BSID), 3rd or 4th Ed. Composite Score (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)
Secondary Outcomes
- Gross Motor Function Classification System Scale (GMFCS)(22-26 months corrected gestational age)
- Moderate/Severe Neurodevelopmental Impairment(22-26 months corrected gestational age)
- Mild Neurodevelopmental Impairment(22-26 months corrected gestational age)
- Cerebral Palsy (CP)(22-26 months corrected gestational age)
- Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC(22-26 months corrected gestational age)
- Any grade intraventricular hemorrhage (IVH) in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)(From birth through hospital discharge, up to 6 months corrected gestational age (CGA))
- Death in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)(From birth through hospital discharge, up to 6 months corrected gestational age (CGA))
- Compare neurodevelopmental outcomes from BSID assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC.(22-26 months corrected gestational age)
- Compare neurodevelopmental outcomes from ASQ assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC.(22-26 months corrected gestational age)
- Developmental Outcomes assessed by Ages & Stages Questionnaire, 3rd ed. (ASQ-3) five domains: Communication, Gross motor, Fine motor, Problem solving and Personal-social in infants born between 23-32+6 weeks GA who received UCM or DCC.(22-26 months corrected gestational age)
- Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool.(22-26 months corrected gestational age)