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

Sharp HealthCare

Status

Completed

Conditions

Neurodevelopmental Abnormality

Treatments

Procedure: Umbilical Cord Milking

Procedure: Early Cord Clamping

Study type

Interventional

Funder types

Other

Identifiers

NCT03621943

MINVIFU

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,207 patients

Sex

All

Ages

22 to 26 months old

Volunteers

No Healthy Volunteers

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