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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia
• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy

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