| CTRI Number |
CTRI/2025/07/090984 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
How Different Ways of Handling the Umbilical Cord at Birth Affect Blood Flow in Premature Babies |
|
Scientific Title of Study
|
Effect of immediate cord clamping, intact cord milking, and cut cord milking on hemodynamics in non-vigorous preterm neonates born at 28+0 to 33+6 Weeks’ Gestation: A Randomized Controlled Trial (CORDIAL) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zulquarnain |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Neonatology,
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar Pondicherry PONDICHERRY 605006 India |
| Phone |
9058785869 |
| Fax |
|
| Email |
zulquarnain1995@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Usha Devi R |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Neonatology,
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar Pondicherry PONDICHERRY 605006 India |
| Phone |
9962653294 |
| Fax |
|
| Email |
drushaa@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Usha Devi R |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Neonatology,
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar Pondicherry PONDICHERRY 605006 India |
| Phone |
9962653294 |
| Fax |
|
| Email |
drushaa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Usha Devi |
JIPMER |
NICU, First floor- Women and Children Hospital Block, JIPMER, JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar, Puducherry-605006 Pondicherry PONDICHERRY |
9962653294
dr.ushaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTI TUTIONAL ETHICS COMMITTEE - INTERVENTIONA L STUDIES JIPMER, PUDUCHERRY |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cut umbilical cord milking |
Non vigorous neonates born between 28+0 to 33+6 weeks will receive cut umbilical cord milking. |
| Comparator Agent |
immediate cord clamping |
Non vigorous neonate born between 28+0 to 33+6 weeks receiving immediate cord clamping at birth |
| Intervention |
intact umbilical cord milking |
Non vigorous neonates born between 28+0 to 33+6 weeks will receive intact umbilical cord milking. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
Non vigorous (not breathing or crying at birth) neonates born between 28+0 to 33+6 weeks gestation age. |
|
| ExclusionCriteria |
| Details |
Antenatally detected major malformations, hydrops fetalis, suspected chromosomal anomalies, Rh negative pregnancies with positive ICT, Monochorionic twins, cord prolapse, antepartum hemorrhage. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Superior vena cava flow |
12 ±2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Saturation and heart rate |
5 mins |
| temperature |
10 mins |
| hematocrit |
4(±2) hrs |
| Mean blood pressure, perfusion index and need for inotropic support |
24(±2) hours |
| Intraventricular hemorrhage (IVH), mortality |
28 days |
| Hematocrit and ferritin levels |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="141" Sample Size from India="141"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial is being conducted at the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, to compare the efficacy of three umbilical cord management techniques in non-vigorous preterm neonates born between 28+0 and 33+6 weeks gestation. The aim is to determine which method best improves early cardiovascular stability, particularly when delayed cord clamping is not feasible due to the need for immediate neonatal resuscitation. Current neonatal resuscitation guidelines recommend delayed cord clamping in vigorous preterm infants; however, evidence is lacking for non-vigorous preterms who require urgent intervention. Cord milking—both intact and cut—has emerged as a potential alternative, offering rapid placental transfusion without delaying resuscitation. This study evaluates Intact Umbilical Cord Milking (I-UCM) and Cut Umbilical Cord Milking (C-UCM) against Immediate Cord Clamping (ICC). A total of 141 preterm neonates who meet the inclusion criteria (non-vigorous, 28–33+6 weeks GA, not requiring major resuscitation) will be randomized in a 1:1:1 ratio using block randomization into one of the three intervention arms. I-UCM involves milking the intact umbilical cord three times before clamping, C-UCM involves cutting and then milking the cord, and ICC refers to immediate clamping within 30 seconds after birth. The primary outcome is Superior Vena Cava (SVC) flow at 12 ± 2 hours of life, measured by functional echocardiography. SVC flow is a validated surrogate marker for systemic perfusion in preterm infants and provides insight into cardiovascular transition. The study uses standard echocardiographic protocols and is conducted by personnel trained in neonatal functional echocardiography. Secondary outcomes include:
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Hematological indices: hematocrit and serum ferritin levels at 12 hours
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Heart rate and blood pressure trends in the first 12 hours
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Incidence of intraventricular hemorrhage (IVH) on cranial ultrasound at 72 hours
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Need for respiratory or inotropic support
-
Early neonatal mortality
Additional data on cord blood gases, APGAR scores, and NICU course (e.g., ventilation needs, oxygen days) will also be collected. Ethical approval has been obtained from the JIPMER Institute Ethics Committee. Written informed consent will be obtained from parents prior to delivery.
This study addresses an important clinical challenge—optimizing cord management in non-vigorous preterm infants. By directly comparing I-UCM, C-UCM, and ICC, the findings may influence resuscitation practices, especially in resource-limited settings where delayed cord clamping with intact cord ventilation is not feasible. Positive results favoring cord milking could lead to broader adoption of these techniques and potentially improve early systemic perfusion and neonatal outcomes in vulnerable preterm populations. |