Study 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).
Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
MIDAB-FU
Long-term Outcomes of Umbilical Cord Milking in Term and Late Preterm Neonates Who Are Depressed at Birth
1 other identifier
interventional
N/A
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2022
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
September 24, 2018
CompletedStudy Start
First participant enrolled
October 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2026
ExpectedApril 25, 2023
April 1, 2023
1.7 years
September 20, 2018
April 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Neurodevelopmental Outcome at 2 Years of Age
Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire
22-26 months
Secondary Outcomes (3)
Fidgety Movements at 3 months of age
3-5 months
Neurodevelopmental Outcome at 1 Year of Age
10-14 months
Autism Outcome
22-26 months
Study Arms (2)
Umbilical Cord Milking
ACTIVE COMPARATORAt 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.
Immediate Cord Clamping
NO INTERVENTIONThe umbilical cord is clamped immediately after the delivery.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Enrolled in MIDAB trial
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nemours Children's Cliniclead
- NPKSIMS, Nagpur, Indiacollaborator
- Sharp HealthCarecollaborator
Study Sites (3)
Daga Memorial Woman and Children Hospital
Nagpur, MS, 440002, India
Government Medical College and Hospital
Nagpur, MS, 440009, India
NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Nagpur, MS, 440019, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zubair Aghai, MD
Nemours Children's Clinic
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
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
September 20, 2018
First Posted
September 24, 2018
Study Start
October 17, 2022
Primary Completion
June 16, 2024
Study Completion (Estimated)
August 16, 2026
Last Updated
April 25, 2023
Record last verified: 2023-04