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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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
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:

  • Hematological indices: hematocrit and serum ferritin levels at 12 hours

  • Heart rate and blood pressure trends in the first 12 hours

  • Incidence of intraventricular hemorrhage (IVH) on cranial ultrasound at 72 hours

  • 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.

 
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