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WithdrawnNCT03681314MIDAB-FUUpdated Apr 25, 2023

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

An interventional study of Umbilical Cord Milking in Hypoxic-Ischemic Encephalopathy and Birth Asphyxia, sponsored by Nemours Children's Clinic. Withdrawn at 3 sites in India. Open to participants aged 3 Months to 26 Months. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
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).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
3 Months to 26 Months
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Hypoxic-Ischemic Encephalopathy
  • Birth Asphyxia
03

In context

Hypoxia-Ischemia, Brain

261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 95 are open to participants now.

Browse Hypoxia-Ischemia, Brain studies →

Lead sponsor

Nemours Children's Clinic is the lead sponsor of 130 studies on the registry; 26 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 26 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Enrolled in MIDAB trial

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

  • No intervention
    Immediate Cord Clamping

    The umbilical cord is clamped immediately after the delivery.

Interventions

  • OtherUmbilical 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.

06

What researchers measure

Primary outcomes

  1. Neurodevelopmental Outcome at 2 Years of Age

    Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire

    Time frame: 22-26 months

Secondary outcomes

  1. Fidgety Movements at 3 months of age

    Assessment of Fidgety Movements by Prechtl's method

    Time frame: 3-5 months

  2. Neurodevelopmental Outcome at 1 Year of Age

    Developmental Activities Screening Inventory - Second Edition (DASI-II)

    Time frame: 10-14 months

  3. Autism Outcome

    Modified Checklist for Autism in Toddlers (M-CHAT-R)

    Time frame: 22-26 months

07

Study locations

3 sites
  • 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
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2022 (actual). Primary completion is estimated for Jun 2024, 19 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2018
First posted
Sep 24, 2018
StartActual
Oct 17, 2022
Primary completionEst.
Jun 16, 2024
CompletionEst.
Aug 16, 2026
Last update
Apr 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03681314
Collaborators
NPKSIMS, Nagpur, India, Sharp HealthCare
Responsible party
Zubair Aghai (Professor of Pediatrics, Nemours Children's Clinic) — Principal investigator
First posted
Sep 24, 2018
Start date
Oct 17, 2022
Primary completion
Jun 16, 2024 (estimated)
Completion
Aug 16, 2026 (estimated)
Last update
Apr 25, 2023

Study contacts

Zubair Aghai, MD
principal investigator · Nemours Children's Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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