NCT03621943

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2021

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 27, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

August 6, 2018

Results QC Date

September 12, 2024

Last Update Submit

March 7, 2025

Conditions

Neurodevelopmental Abnormality

Keywords

Neurodevelopmental outcomesDisabilityUmbilical cord milkingEarly cord clampingNon-vigorous infantsTerm infantsNear-Term infantsDevelopmental screeningEarly childhood

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Score Ranges on the Modified Checklist for Autism in Toddlers Questionnaire

    22-26 months

Study Arms (2)

Umbilical Cord Milking

ACTIVE COMPARATOR

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

Early Cord Clamping

ACTIVE COMPARATOR

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

Procedure: Early Cord Clamping

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.

Umbilical Cord Milking
Early Cord ClampingPROCEDURE

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

Early Cord Clamping

Eligibility Criteria

Age22 Months - 26 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of California, Davis

Davis, California, 95616, United States

Location

Loma Linda Medical Center

Loma Linda, California, 92350, United States

Location

Sharp Grossmont Hospital

San Diego, California, 91942, United States

Location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225-6603, United States

Location

University of Utah/IMH

Salt Lake City, Utah, 84113, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

Dalhousie University

Dalhousie, New Brunswick, E8C 2R6, Canada

Location

Poznan University of Medical Science

Poznan, Poland

Location

MeSH Terms

Interventions

Umbilical Cord Clamping

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Limitations and Caveats

This study was conducted in relatively high-income academic centers. Most women had sufficient prenatal care, and almost 80% of the mothers had some college education.

Results Point of Contact

Title
Dr. Anup Katheria
Organization
Sharp Healthcare
Anup.Katheria@sharp.com
8589394170

Study Officials

  • Anup Katheria, MD

    Neonatologist

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neonatal Research Institute

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 9, 2018

Study Start

January 7, 2019

Primary Completion

June 2, 2021

Study Completion

September 26, 2023

Last Updated

March 27, 2025

Results First Posted

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(7)CA(2)PL(1)