Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
- Conditions
- Hypoxic-Ischemic EncephalopathyBirth Asphyxia
- Registration Number
- NCT03681314
- Lead Sponsor
- Nemours Children's Clinic
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Enrolled in MIDAB trial
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Neurodevelopmental Outcome at 2 Years of Age 22-26 months Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire
- Secondary Outcome Measures
Name Time Method Fidgety Movements at 3 months of age 3-5 months Assessment of Fidgety Movements by Prechtl's method
Neurodevelopmental Outcome at 1 Year of Age 10-14 months Developmental Activities Screening Inventory - Second Edition (DASI-II)
Autism Outcome 22-26 months Modified Checklist for Autism in Toddlers (M-CHAT-R)
Trial Locations
- Locations (3)
Daga Memorial Woman and Children Hospital
🇮🇳Nagpur, MS, India
Government Medical College and Hospital
🇮🇳Nagpur, MS, India
NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
🇮🇳Nagpur, MS, India
Daga Memorial Woman and Children Hospital🇮🇳Nagpur, MS, India