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

Primary Purpose

Hypoxic-Ischemic Encephalopathy, Birth Asphyxia

Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Umbilical Cord Milking
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypoxic-Ischemic Encephalopathy

Eligibility Criteria

3 Months - 26 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Enrolled in MIDAB trial

Exclusion Criteria:

  • None

Sites / Locations

  • Daga Memorial Woman and Children Hospital
  • Government Medical College and Hospital
  • NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Umbilical Cord Milking

Immediate Cord Clamping

Arm Description

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.

The umbilical cord is clamped immediately after the delivery.

Outcomes

Primary Outcome Measures

Neurodevelopmental Outcome at 2 Years of Age
Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire

Secondary Outcome Measures

Fidgety Movements at 3 months of age
Assessment of Fidgety Movements by Prechtl's method
Neurodevelopmental Outcome at 1 Year of Age
Developmental Activities Screening Inventory - Second Edition (DASI-II)
Autism Outcome
Modified Checklist for Autism in Toddlers (M-CHAT-R)

Full Information

First Posted
September 20, 2018
Last Updated
April 23, 2023
Sponsor
Nemours Children's Clinic
Collaborators
NPKSIMS, Nagpur, India, Sharp HealthCare
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1. Study Identification

Unique Protocol Identification Number
NCT03681314
Brief Title
Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
Acronym
MIDAB-FU
Official Title
Long-term Outcomes of Umbilical Cord Milking in Term and Late Preterm Neonates Who Are Depressed at Birth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
This study was not funded. The same study with few modifications in the trial was later funded by the NICHD. Now study started enrolling babies using new registration and identification IDs ( NCT03682042 and NCT03657394).
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
June 16, 2024 (Anticipated)
Study Completion Date
August 16, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
Collaborators
NPKSIMS, Nagpur, India, Sharp HealthCare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Neurodevelopmental assessments will be done at 2 years of age (22-26 months) for subjects who were randomized to receive either immediate cord clamping or umbilical cord milking as part of the MIDAB trial.
Masking
Outcomes Assessor
Masking Description
Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Umbilical Cord Milking
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Immediate Cord Clamping
Arm Type
No Intervention
Arm Description
The umbilical cord is clamped immediately after the delivery.
Intervention Type
Other
Intervention Name(s)
Umbilical Cord Milking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neurodevelopmental Outcome at 2 Years of Age
Description
Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire
Time Frame
22-26 months
Secondary Outcome Measure Information:
Title
Fidgety Movements at 3 months of age
Description
Assessment of Fidgety Movements by Prechtl's method
Time Frame
3-5 months
Title
Neurodevelopmental Outcome at 1 Year of Age
Description
Developmental Activities Screening Inventory - Second Edition (DASI-II)
Time Frame
10-14 months
Title
Autism Outcome
Description
Modified Checklist for Autism in Toddlers (M-CHAT-R)
Time Frame
22-26 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
26 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Enrolled in MIDAB trial Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zubair Aghai, MD
Organizational Affiliation
Nemours Children's Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daga Memorial Woman and Children Hospital
City
Nagpur
State/Province
MS
ZIP/Postal Code
440002
Country
India
Facility Name
Government Medical College and Hospital
City
Nagpur
State/Province
MS
ZIP/Postal Code
440009
Country
India
Facility Name
NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
City
Nagpur
State/Province
MS
ZIP/Postal Code
440019
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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