Hypoxic-Ischemic EncephalopathyCORDMILK-FUNCT03682042
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
A study testing Umbilical Cord Milking in people with Hypoxic-Ischemic Encephalopathy and Birth Asphyxia, run by Nemours Children's Clinic at 9 sites in India.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 22 to 26 months
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
- What is being tested?
- Umbilical Cord Milking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,442 participants
- Where
- 9 sitesIndia
- Study dates
- 17 Oct 2022to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 26 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Enrolled in CORDMILK trial
- Non-vigorous at birth
Who cannot join
- None
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
Belagavi, Karnataka, 590010
Government Medical College
Chandrapur, MS, 442401
Sawai Man Singh (SMS) Medical College
Jaipur, Rajasthan, 302004
Indira Gandhi Government Medical College & Hospital
Nagpur, Maharashtra, 440018
Daga Memorial Woman and Children Hospital
Nagpur, MS, 440002
Government Medical College and Hospital
Nagpur, MS, 440009
All India Institute of Medical Science
Nagpur, MS, 441108
Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital
Pune, Maharashtra, 411018
Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
Wardha, MS, 442102
About this study
Official title: 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).
Read the 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.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
- Being tested
- Umbilical Cord Milking
- Keywords
- Placental transfusion
- Medical subject headings
- Hypoxia-Ischemia, Brain, Asphyxia Neonatorum, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord MilkingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Milking | Active comparator | 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. Receives: Other: Umbilical Cord Milking |
| Early Cord Clamping | No intervention | The umbilical cord is clamped immediately after the delivery (within 60 seconds). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental Outcome at 2 Years of Age
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.
Measured: 22-26 months
Secondary outcomes (1)
Neurodevelopmental Outcome at 1 Year of Age
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.
Measured: 10-14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start17 Oct 2022
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Neurodevelopmental assessments will be done at 2 years of age (22-26 months) for subjects who were randomized to receive either early cord clamping or umbilical cord milking as part of the CORDMILK trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Sharp HealthCare, Thomas Jefferson University, University of California, San Diego, St. Louis University, KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India, Government Medical College, Nagpur, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Mahatma Gandhi Institute of Medical Sciences, Karnataka Institute of Medical Sciences, Hubbali, India, All India Institute of Medical Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Indira Gandhi Government Medical College & Hospital, Nagpur, India, Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India
- Responsible party
- Principal investigator, Zubair Aghai, Nemours Children's Clinic
- Investigators
- Zubair Aghai, MD, Principal investigator, Nemours Children's ClinicAnup Katheria, MD, Principal investigator, Sharp Mary Birch Hospital for Women & NewbornsSangappa Dhaded, Principal investigator, KLE Academy of Higher Education and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682042
- Sponsor's protocol ID
- CORDMILK FU
- Other IDs
- R01HD102967
- Acronym
- CORDMILK-FU
- Status last verified
- Jul 2026
- First submitted
- 20 Sep 2018
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yogeshkumar S, Vernekar SS, Dhaded SM, Talekar K, Leiby BE, Hartman R, Vaucher Y, Chouthai N, Girish M, Jain M, Jain S, Parvekar S, Jain V, Patankar A, Suryawanshi M, Tiwari M, Waikar M, Nashine N, Ambike D, Asalkar M, Kulkarni R, Haribhaktha S, Narkhede H, Chaudhari S, Kamble M, Shrirame D, Falke B, Mehta S, Verma A, Gothwal S, Goudar SS, Derman R, Katheria A, Aghai ZH. CORDMILK: Umbilical Cord Milking versus Early Cord Clamping on short-and long-term outcomes in neonates who are non-vigorous at birth-study protocol of a multi-center, cluster-randomized, crossover-controlled trial. Trials. 2025 Nov 17;26(1):509. doi: 10.1186/s13063-025-09197-8.
PubMed 41250198
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03682042
- Acronym / sponsor ID
- CORDMILK-FU / CORDMILK FU
- Conditions
- Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
- Keywords
- Placental transfusion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,442 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Sharp HealthCare, Thomas Jefferson University, University of California, San Diego, St. Louis University, KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India, Government Medical College, Nagpur, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Mahatma Gandhi Institute of Medical Sciences, Karnataka Institute of Medical Sciences, Hubbali, India, All India Institute of Medical Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Indira Gandhi Government Medical College & Hospital, Nagpur, India, Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Neurodevelopmental assessments will be done at 2 years of age (22-26 months) for subjects who were randomized to receive either early cord clamping or umbilical cord milking as part of the CORDMILK trial.
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Milking | Active comparator | Other: Umbilical Cord MilkingAt 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. |
| Early Cord Clamping | No intervention | –The umbilical cord is clamped immediately after the delivery (within 60 seconds). |
Who may qualify
- Ages
- 22 to 26 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Enrolled in CORDMILK trial
- Non-vigorous at birth
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord MilkingAt 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 |
Primary outcome
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.
1 secondary outcome
Neurodevelopmental Outcome at 1 Year of Age
Time frame: 10-14 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 41250198Yogeshkumar S, Vernekar SS, Dhaded SM, Talekar K, Leiby BE, Hartman R, Vaucher Y, Chouthai N, Girish M, Jain M, Jain S, Parvekar S, Jain V, Patankar A, Suryawanshi M, Tiwari M, Waikar M, Nashine N, Ambike D, Asalkar M, Kulkarni R, Haribhaktha S, Narkhede H, Chaudhari S, Kamble M, Shrirame D, Falke B, Mehta S, Verma A, Gothwal S, Goudar SS, Derman R, Katheria A, Aghai ZH. CORDMILK: Umbilical Cord Milking versus Early Cord Clamping on short-and long-term outcomes in neonates who are non-vigorous at birth-study protocol of a multi-center, cluster-randomized, crossover-controlled trial. Trials. 2025 Nov 17;26(1):509. doi: 10.1186/s13063-025-09197-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zubair Aghai, MD principal investigator
Nemours Children's Clinic
Anup Katheria, MD principal investigator
Sharp Mary Birch Hospital for Women & Newborns
Sangappa Dhaded principal investigator
KLE Academy of Higher Education and Research
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical Cord Milking in people with Hypoxic-Ischemic Encephalopathy and Birth Asphyxia, run by Nemours Children's Clinic at 9 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopmental Outcome at 2 Years of Age (time frame: 22-26 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.