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

Study Overview

• Status: Completed
• Conditions: Neurodevelopmental Abnormality
• Intervention / Treatment: Procedure: Umbilical Cord Milking; Procedure: Early Cord Clamping

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.

• Study Type: Interventional
• Enrollment (Actual): 1207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R3
      • University of Alberta
  • New Brunswick
    • Dalhousie, New Brunswick, Canada, E8C 2R6
      • Dalhousie University
• Poland
  • Poznań, Poland
    • Poznań University of Medical Science
• United States
  • California
    • Davis, California, United States, 95616
      • University of California, Davis
    • Loma Linda, California, United States, 92350
      • Loma Linda Medical Center
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women and Newborns
    • San Diego, California, United States, 91942
      • Sharp Grossmont Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20052
      • George Washington University
  • Oregon
    • Portland, Oregon, United States, 97225-6603
      • Providence St. Vincent Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah/IMH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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: Umbilical Cord Milking; At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped.
Active Comparator: Early Cord Clamping; The umbilical cord is clamped as soon as possible and within 60 seconds of delivery.	Procedure: Early Cord Clamping; The umbilical cord is clamped as soon as possible and within 60 seconds of delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition.	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	22 to 26 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score Ranges on the Modified Checklist for Autism in Toddlers Questionnaire	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.	22-26 months

Collaborators and Investigators

• Sponsor: Sharp HealthCare
• Investigators: Principal Investigator: Anup Katheria, MD, Neonatologist

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): June 2, 2021
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Disability; Early childhood; Term infants; Neurodevelopmental outcomes; Umbilical cord milking; Early cord clamping; Non-vigorous infants; Near-Term infants; Developmental screening
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: MINVIFU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No