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

NCT ID: NCT03621943

Last Updated: 2025-03-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2023-09-26

Brief Summary

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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

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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

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Neurodevelopmental Abnormality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization assignment was determined at time of enrollment in the primary study (Umbilical Cord Milking in Nonvigorous Infants Study NCT:03631940). The primary study model was a cluster randomized crossover trial.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.

Study Groups

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Umbilical Cord Milking

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

Group Type ACTIVE_COMPARATOR

Umbilical Cord Milking

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Early Cord Clamping

Intervention Type PROCEDURE

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

Interventions

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Umbilical Cord Milking

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

Intervention Type PROCEDURE

Early Cord Clamping

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

22 Months

Maximum Eligible Age

26 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sharp HealthCare

OTHER

Sponsor Role lead

Responsible Party

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Anup Katheria, M.D.

Director, Neonatal Research Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anup Katheria, MD

Role: PRINCIPAL_INVESTIGATOR

Neonatologist

Locations

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University of California, Davis

Davis, California, United States

Site Status

Loma Linda Medical Center

Loma Linda, California, United States

Site Status

Sharp Grossmont Hospital

San Diego, California, United States

Site Status

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

Providence St. Vincent Medical Center

Portland, Oregon, United States

Site Status

University of Utah/IMH

Salt Lake City, Utah, United States

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Dalhousie University

Dalhousie, New Brunswick, Canada

Site Status

Poznan University of Medical Science

Poznan, , Poland

Site Status

Countries

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United States Canada Poland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MINVIFU

Identifier Type: -

Identifier Source: org_study_id

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