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NCT03681314 Clinical Trial

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

Hypoxic-Ischemic Encephalopathy Clinical Trial

— MIDAB-FU  

Official title:
Long-term Outcomes of Umbilical Cord Milking in Term and Late Preterm Neonates Who Are Depressed at Birth

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03681314
Other study ID # UCM2018FU
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 17, 2022
Est. completion date August 16, 2026

Study information
Verified date April 2023
Source Nemours Children's Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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 information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 16, 2026
Est. primary completion date June 16, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Months to 26 Months
Eligibility Inclusion Criteria: - Enrolled in MIDAB trial Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
India 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

Sponsors (3)
Lead Sponsor Collaborator
Nemours Children's Clinic NPKSIMS, Nagpur, India, Sharp HealthCare

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neurodevelopmental Outcome at 2 Years of Age Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire 22-26 months
Secondary Fidgety Movements at 3 months of age Assessment of Fidgety Movements by Prechtl's method 3-5 months
Secondary Neurodevelopmental Outcome at 1 Year of Age Developmental Activities Screening Inventory - Second Edition (DASI-II) 10-14 months
Secondary Autism Outcome Modified Checklist for Autism in Toddlers (M-CHAT-R) 22-26 months
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