PretermCORDMILK-PTNCT06240715
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm
A study testing Umbilical cord milking in people with Preterm and Infant Death, run by Nemours Children's Clinic at 9 sites in India.
Trial summary
The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation. Read more about this study
- Who is it for?
- Ages 0 to 10 minutes
- Conditions the study is for
- Preterm, Infant Death
- What is being tested?
- Umbilical cord milking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 9 sitesIndia
- Study dates
- 1 Jul 2024to 30 Mar 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 0 to 10 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
- Non-vigorous at birth
Who cannot join
- Infants with congenital malformation
- Major chromosomal abnormalities
- Complete placental abruption/cutting through the placenta at the time of delivery
- Cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord)
- Mono-chorionic twins,
- Twins with no information on amnion/chorion
- Multiple gestation >2
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
India9 sites, 9 recruiting
- Not yet recruiting
KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
Belagavi, Karnataka, 590010
Sangappa Dhaded, MD, +91 98442 32586, drdhadedsm@gmail.com
Shivaprasad Goudar, MD
- Not yet recruiting
Government Medical College
Chandrapur, Maharashtra, 442401
Milind Kamble, MD, mkamble1732@ymail.com
Milind Kamble, MD
- Recruiting
Osmania Medical College, Niloufer Hospital
Hyderabad, Telangana, 500004
D Suchitra, MD
- Recruiting
Sawai Man Singh Medical College
Jaipur, Rajasthan, 302004
Seema Mehta, MD
Seema Mehta, MD
- Not yet recruiting
Indira Gandhi Government Medical College & Hospital
Nagpur, Maharashtra, 440018
Alka Patankar, MD, alkajatkar@gmail.com
Milind Suryavanshi, MD
- Recruiting
Daga Memorial Woman and Children Hospital
Nagpur, MS, 440002
Seema Parvekar, MD, +91-98909 87153, seemaparvekar@gmail.com
Vineeta Jain, MD
- Not yet recruiting
Government Medical College and Hospital
Nagpur, MS, 440009
Manish Tiwari, MD, +91 9552526538, manishtiwari.peds@rediffmail.com
Manoj Bhatnagar, MD
- Not yet recruiting
Yashwantrao Chavan Memorial Hospital
Pune, Maharashtra, 411018
Mahesh Asalkar, MD, mahesh@asalkarclinic.com
Mahesh Asalkar, MD
- Not yet recruiting
Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
Wardha, MS, 442102
Manish Jain, MD, +91-98226 95195, manish@mgims.ac.in
Manish Jain, MD
About this study
Official title: A Cluster Randomized Clinical Trial of Umbilical Cord Milking Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth
The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.
Read the detailed description
Background: Prematurity is the leading cause of death in children younger than 5 years of age. Worldwide, 15 million infants are born premature, and India alone contributes to quarter of them. Approximately 1 million children die each year due to complications of prematurity.
Delayed cord clamping (DCC), one of the methods of transfer of placental blood to neonates (placental transfusion) immediately after birth reduce mortality by 30% in premature infants. But DCC is not recommended in neonates who require immediate resuscitation. Umbilical cord milking (UCM) is an option for placental transfusion in preterm infants who require immediate resuscitation but not currently recommended due to lack of randomized clinical trials.
HYPOTHESIS: UCM will reduce the in-hospital mortality in non-vigorous preterm infants born between 30 weeks to 34 weeks of gestation compared to early cord clamping.
METHODS: This multicenter cluster crossover randomized trial will enroll approximately 800 preterm infants to early cord clamping or milking the intact cord 4 times prior to clamping.
IMPACT: If investigators find that UCM is beneficial, this simple, low-tech, no cost intervention can be used in preventing deaths in preterm infants. This trial will potentially provide evidence to support a change in guidelines making UCM part of standard practice worldwide for preterm infants who require immediate resuscitation.
- Conditions
- Preterm, Infant Death
- Being tested
- Umbilical cord milking
- Keywords
- Preterm, Umbilical cord milking, Placental transfusion
- Medical subject headings
- Premature Birth, Infant Death, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord milkingProcedure or surgery
Also called UCM
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 1--15 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Milking | Active comparator | The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for early cord clamping (ECC). Receives: Procedure: Umbilical cord milking |
| Early Cord Clamping | No intervention | Umbilical cord will be clamped immediately after birth (within 60 seconds) |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Death of a baby during birth hospitalization
Measured: From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, assessed up to 12 weeks
Secondary outcomes (10)
Hemoglobin at or after 24 hours
Hb levels
Measured: Days 1-7
Early and late onset culture positive sepsis
Number of infants with early onset or late onset sepsis
Measured: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Any intraventricular hemorrhage (IVH) and severe IVH (grade 3 or 4)
Number of infants with any IVH or severe IVH
Measured: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Need for blood transfusion
Number of infants received blood transfusion
Measured: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Moderate to severe hypoxemic ischemic encephalopathy
Number of infants with moderate to severe hypoxemic ischemic encephalopathy
Measured: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Necrotizing enterocolitis (Bell's stage 2 or higher)
Number of infants with necrotizing enterocolitis (Bell's stage 2 or higher)
Measured: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Need for medications for hypotension
Number of infants needed medications for hypotension
Measured: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Need for phototherapy for jaundice
Number of infants needed phototherapy for jaundice
Measured: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Retinopathy of prematurity (ROP) requiring intervention
Number of infants with ROP that required intervention
Measured: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Length of hospitalization
Number of days infants stayed in hospital
Measured: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Jul 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies 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
- Cluster Randomized Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, Thomas Jefferson University, Sharp HealthCare, Jawaharlal Nehru Medical College, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Mahatma Gandhi Institute of Medical Sciences, Indira Gandhi Government Medical College & Hospital, Nagpur, India, Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India, Government Medical College, Nagpur, Government Medical College, Chandrapur, India, Osmania Medical College, Niloufer Hospital, Hyderabad, India
- Responsible party
- Principal investigator, Zubair Aghai, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240715
- Sponsor's protocol ID
- CORDMILK-PT
- Acronym
- CORDMILK-PT
- Status last verified
- Jul 2026
- First submitted
- 26 Jan 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth
- ClinicalTrials.gov ID
- NCT06240715
- Acronym / sponsor ID
- CORDMILK-PT / CORDMILK-PT
- Conditions
- Preterm, Infant Death
- Keywords
- Preterm, Umbilical cord milking, Placental transfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Thrasher Research Fund, Thomas Jefferson University, Sharp HealthCare, Jawaharlal Nehru Medical College, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Mahatma Gandhi Institute of Medical Sciences, Indira Gandhi Government Medical College & Hospital, Nagpur, India, Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India, Government Medical College, Nagpur, Government Medical College, Chandrapur, India, Osmania Medical College, Niloufer Hospital, Hyderabad, India
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 5 Feb 2024 (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.
The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.
Detailed description
Background: Prematurity is the leading cause of death in children younger than 5 years of age. Worldwide, 15 million infants are born premature, and India alone contributes to quarter of them. Approximately 1 million children die each year due to complications of prematurity.
Delayed cord clamping (DCC), one of the methods of transfer of placental blood to neonates (placental transfusion) immediately after birth reduce mortality by 30% in premature infants. But DCC is not recommended in neonates who require immediate resuscitation. Umbilical cord milking (UCM) is an option for placental transfusion in preterm infants who require immediate resuscitation but not currently recommended due to lack of randomized clinical trials.
HYPOTHESIS: UCM will reduce the in-hospital mortality in non-vigorous preterm infants born between 30 weeks to 34 weeks of gestation compared to early cord clamping.
METHODS: This multicenter cluster crossover randomized trial will enroll approximately 800 preterm infants to early cord clamping or milking the intact cord 4 times prior to clamping.
IMPACT: If investigators find that UCM is beneficial, this simple, low-tech, no cost intervention can be used in preventing deaths in preterm infants. This trial will potentially provide evidence to support a change in guidelines making UCM part of standard practice worldwide for preterm infants who require immediate resuscitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized Crossover
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Milking | Active comparator | Procedure: Umbilical cord milkingThe delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for early cord clamping (ECC). |
| Early Cord Clamping | No intervention | –Umbilical cord will be clamped immediately after birth (within 60 seconds) |
Who may qualify
- Ages
- 0 to 10 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
- Non-vigorous at birth
Key exclusion criteria (7 listed)
- Infants with congenital malformation
- Major chromosomal abnormalities
- Complete placental abruption/cutting through the placenta at the time of delivery
- Cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord)
- Mono-chorionic twins,
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 milkingAlso: UCMAt 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 1--15 seconds. | Procedure or surgery | Umbilical Cord Milking |
Primary outcome
In-hospital mortality
Time frame: From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, assessed up to 12 weeks
Death of a baby during birth hospitalization
10 secondary outcomes
Hemoglobin at or after 24 hours
Time frame: Days 1-7
Early and late onset culture positive sepsis
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Any intraventricular hemorrhage (IVH) and severe IVH (grade 3 or 4)
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Need for blood transfusion
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Moderate to severe hypoxemic ischemic encephalopathy
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Necrotizing enterocolitis (Bell's stage 2 or higher)
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Need for medications for hypotension
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Need for phototherapy for jaundice
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Retinopathy of prematurity (ROP) requiring intervention
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Length of hospitalization
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
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.
- Individual participant dataSharing planned: Yes
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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.
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 Preterm and Infant Death, 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 7 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: looking for participants now, 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?
Contact Zubair H Aghai, MD (215 955 6523, zaghai@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, assessed up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.