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Completed

NCT Number: NCT03621943

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

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.

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Key information

Conditions

Neurodevelopmental Abnormality

Age range

22 month–26 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in the primary trial NCT:03631940 and parental written consent to participate in developmental follow-up through 2 years of age was obtained.
  • Enrolled in the primary trial NCT:03631940 and did not survive to 2 years.

Exclusion criteria

  • Enrolled in the primary trial NCT:03631940 but parent/guardian declined consent to developmental follow-up participation.

Treatment and study plan

Umbilical Cord Milking

Procedure

At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.

Early Cord Clamping

Procedure

The umbilical cord is clamped as soon as possible and within 60 seconds of delivery.

Primary outcomes

  1. Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition.

    Time frame: 22 to 26 months

    Neurodevelopmental Outcome at 2 Years of Age defined as overall and domain scores on the Ages and Stages, third edition. Questionnaire. Minimum score of 0 and maximum score of 60 per domain. Scores from 5 subscales are summed to obtain a total score. 5 domains assessed include communication, gross motor, fine motor, problem solving, personal social with a total minimum score of 0 and maximum score of 300. Higher scores indicate a lower risk of developmental delays or conditions

Secondary outcomes

  1. Score Ranges on the Modified Checklist for Autism in Toddlers Questionnaire

    Time frame: 22-26 months

    Modified Checklist for Autism in Toddlers. Minimum score of 0 and maximum score of 20. Higher scores indicate higher risk for autism spectrum disorder. Total scores of 0 to 2 indicates a low risk of autism spectrum disorder. Total scores of 3 to 7 indicates a moderate risk of autism spectrum disorder. Total scores of 8 to 20 indicate high risk of autism spectrum disorder.

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Registry information

Acronym: MINVIFU

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Aug 9, 2018
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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