Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU) (MIDAB-FU)

April 23, 2023 updated by: Zubair Aghai, Nemours Children's Clinic

Long-term Outcomes of Umbilical Cord Milking in Term and Late Preterm Neonates Who Are Depressed at Birth

An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The MIDAB-Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were depressed at birth and enrolled in MIDAB trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ICC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • MS
      • Nagpur, MS, India, 440002
        • Daga Memorial Woman and Children Hospital
      • Nagpur, MS, India, 440009
        • Government Medical College and Hospital
      • Nagpur, MS, India, 440019
        • Nkp Salve Institute of Medical Sciences and Lata Mangeshkar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 1 year (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Enrolled in MIDAB trial

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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. This procedure infuses a placental transfusion of blood into the infant and can be done in 10-15 seconds.
Other: Umbilical Cord Milking
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 10-15 seconds.
No Intervention: Immediate Cord Clamping
The umbilical cord is clamped immediately after the delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurodevelopmental Outcome at 2 Years of Age
Time Frame: 22-26 months
Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire
22-26 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fidgety Movements at 3 months of age
Time Frame: 3-5 months
Assessment of Fidgety Movements by Prechtl's method
3-5 months
Neurodevelopmental Outcome at 1 Year of Age
Time Frame: 10-14 months
Developmental Activities Screening Inventory - Second Edition (DASI-II)
10-14 months
Autism Outcome
Time Frame: 22-26 months
Modified Checklist for Autism in Toddlers (M-CHAT-R)
22-26 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Collaborators

Sharp HealthCare
NPKSIMS, Nagpur, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2022

Primary Completion (Anticipated)

June 16, 2024

Study Completion (Anticipated)

August 16, 2026

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 20, 2018

First Posted (Actual)

September 24, 2018

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCM2018FU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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