NCT03621943

Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,207 (actual)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 22 Months – 26 Months
• Healthy volunteers: Not accepted

Summary

A sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery.

Detailed description

This sub-study investigates the potential difference in neurodevelopmental outcomes during early childhood between newborns who undergo umbilical cord milking and those who experience early cord clamping at birth. The developmental progress of participants is evaluated using the Ages and Stages Questionnaire-3 which measures five developmental areas: communication, problem-solving, fine motor skills, gross motor skills, and personal-social behavior. Additionally, the Modified Checklist for Autism in Toddlers is employed as a secondary assessment. The recruitment of participants is conducted through the primary study Umbilical Cord Milking in Nonvigorous Infants trial (NCT03631940) with the method of umbilical cord management for each newborn being dictated by the randomized treatment allocation of the primary study.

Conditions

• Neurodevelopmental Abnormality

Interventions

Type	Name	Description
PROCEDURE	Umbilical Cord Milking	At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.
PROCEDURE	Early Cord Clamping	The umbilical cord is clamped as soon as possible and within 60 seconds of delivery.

Timeline

• Start date: 2019-01-07
• Primary completion: 2021-06-02
• Completion: 2023-09-26
• First posted: 2018-08-09
• Last updated: 2025-03-27
• Results posted: 2025-03-27

Locations

10 sites across 3 countries: United States, Canada, Poland