Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)

Not Applicable

Withdrawn

• Conditions: Hypoxic-Ischemic Encephalopathy; Birth Asphyxia
• Interventions: Other: Umbilical Cord Milking

• 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.

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-24
• Study Start: 2022-10-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-23
• Last Update Posted: 2023-04-25
• Primary Completion: 2024-06-16
• Study Completion: 2026-08-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Enrolled in MIDAB trial

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umbilical Cord Milking	Umbilical Cord Milking	At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 10-15 seconds.

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