Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up (CORDMILK-FU)
July 9, 2026 updated by: Zubair Aghai, Nemours Children's Clinic
A Cluster Randomized Clinical Trial of Umbilical Cord Milking Versus Early Cord Clamping on Short and Long-term Outcomes in Neonates Who Are Non-Vigorous at Birth
An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking (UCM) or early cord clamping (ECC).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The CORDMILK Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were non-vigorous at birth and enrolled in the CORDMILK trial.
The difference in survival and neurodevelopmental impairment in infants who received UCM and ECC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.
Study Type
Interventional
Enrollment (Estimated)
3442
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
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-
Karnataka
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Belagavi, Karnataka, India, 590010
- KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
-
-
MS
-
Chandrapur, MS, India, 442401
- Government Medical College
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Nagpur, MS, India, 440002
- Daga Memorial Woman and Children Hospital
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Nagpur, MS, India, 440009
- Government Medical College and Hospital
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Nagpur, MS, India, 441108
- All India Institute of Medical Science
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Wardha, MS, India, 442102
- Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
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-
Maharashtra
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Nagpur, Maharashtra, India, 440018
- Indira Gandhi Government Medical College & Hospital
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Pune, Maharashtra, India, 411018
- Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital
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Rajasthan
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Jaipur, Rajasthan, India, 302004
- Sawai Man Singh (SMS) Medical College
-
-
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
1 year to 2 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Enrolled in CORDMILK trial
- Non-vigorous at birth
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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover 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.
|
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: Early Cord Clamping
The umbilical cord is clamped immediately after the delivery (within 60 seconds).
|
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
|
Neurodevelopmental assessment will be performed by the trained and experienced examiner who will be blinded to the interventions. Severe neurodevelopmental impairment will be defined having at least one of the following: BSID (IV) composite cognitive score <70, GMFCS level 3-5, blindness (vision <20/200), or hearing impairment requiring hearing aids/cochlear implant. Moderate neurodevelopmental impairment will be defined as having a cognitive composite score 70-84, GMFCS level 2, unilateral blindness (vision/20/200 in only one eye), or hearing impairment with no amplification/cochlear implant. |
22-26 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurodevelopmental Outcome at 1 Year of Age
Time Frame: 10-14 months
|
Neurodevelopmental assessment will be performed by the trained and experienced examiner who will be blinded to the intervention using the Developmental Assessment Scales for Indian Infants (DASII).
DAASI provides developmental motor quotient (DMoQ), developmental mental quotient (DMeQ), and composite developmental quotient (DQ).
With a mean DQ of 100 and standard deviation (SD) of 15, 1SD and 2SD below mean correspond to DQ of 85 and 70, respectively.
A DMoQ, DMeQ or DQ score of <70 (2SD) is considered as neurodevelopmental impairment.
|
10-14 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sangappa Dhaded, KLE Academy of Higher Education and Research
- Principal Investigator: Zubair Aghai, MD, Nemours Children's Clinic
- Principal Investigator: Anup Katheria, MD, Sharp Mary Birch Hospital for Women & Newborns
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Estimated)
August 30, 2027
Study Completion (Estimated)
October 30, 2027
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)
July 13, 2026
Last Update Submitted That Met QC Criteria
July 9, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Infant, Newborn, Diseases
- Brain Ischemia
- Hematologic Diseases
- Signs and Symptoms, Respiratory
- Anemia
- Hypoxia, Brain
- Hypoxia
- Anemia, Neonatal
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Hemic and Lymphatic Diseases
- Hypoxia-Ischemia, Brain
- Asphyxia Neonatorum
- Fetofetal Transfusion
- Surgical Procedures, Operative
- Delivery, Obstetric
- Obstetric Surgical Procedures
- Umbilical Cord Clamping
Other Study ID Numbers
- CORDMILK FU
- R01HD102967 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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