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

N/ACompletedNCT03621943

Sharp HealthCare1,207 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

1,207

Conditions

Neurodevelopmental Abnormality

Interventions

Umbilical Cord MilkingPROCEDURE

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

Early Cord ClampingPROCEDURE

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

Eligibility

Sex: ALLMin age: 22 MonthsMax age: 26 Months

Medical Language ↔ Plain English

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.

Locations (10)

University of California, Davis

Davis, California, United States

Loma Linda Medical Center

Loma Linda, California, United States

Sharp Grossmont Hospital

San Diego, California, United States

Outcomes

Primary Outcomes

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

Time frame: 22 to 26 months

Secondary Outcomes

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.

Time frame: 22-26 months

Data from ClinicalTrials.gov

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