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CTRI Number  CTRI/2025/10/096001 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Resuscitation of premature babies born before 32 weeks without cutting the umbilical cord. 
Scientific Title of Study   Outcomes of preterm neonates less than equal to 32 weeks of gestational age with intact cord resuscitation a prospective observational analytical study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ayan Das 
Designation  PGT Department of Pediatrics  
Affiliation  Medical College and Hospital Kolkata  
Address  SNCU Department of pediatrics Eden building 2nd floor Medical College and Hospital, Kolkata 88, College Street Kolkata 73
88, College Street Kolkata 73
Kolkata
WEST BENGAL
700073
India 
Phone  8145084339  
Fax    
Email  ayan.d.uchiha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Munian 
Designation  Associate Professor Department of Pediatrics  
Affiliation  Medical College and Hospital Kolkata  
Address  SNCU Eden building 2nd floor Medical College and Hospital 88, College Street
Medical College and Hospital 88, College Street
Kolkata
WEST BENGAL
700073
India 
Phone  9163288916  
Fax    
Email  Dr.dineshmunian@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dinesh Munian 
Designation  Associate Professor  
Affiliation  Medical College and Hospital Kolkata  
Address  SNCU Eden building 2nd floor Medical College and Hospital 88, College Street
SNCU Eden building 2nd floor Medical College and Hospital 88, College Street
Kolkata
WEST BENGAL
700073
India 
Phone  9163288916  
Fax    
Email  Dr.dineshmunian@gmail.com  
 
Source of Monetary or Material Support  
SNCU Eden building 2nd floor Medical College and Hospital 88, College Street  
 
Primary Sponsor  
Name  Dr. Ayan Das 
Address  Chandpara B.M.Pally P.O Chandpara Bazar P.S Gaighata North 24 PGS West Bengal 743245 
Type of Sponsor  Other [Self] 
 
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 Dinesh Munian   Medical College and Hospital Kolkata   SNCU Department of pediatrics Eden building 2nd floor Medical College and Hospital 88, College Street
Kolkata
WEST BENGAL 		 91632 88916

dr.dineshmunian@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for human research , Medical College,Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P039||Newborn affected by complication of labor and delivery, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Cord Clamping  Neonates in whom the umbilical cord is clamped immediately (within 30 seconds of birth), and resuscitation is initiated after clamping 
Intervention  Intact cord resuscitation.  Neonates receive initial resuscitation/stabilization measures (drying, stimulation, bag and mask ventilation, etc.) with the umbilical cord still intact. 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  90.00 Day(s)
Gender  Both 
Details  Gestational age less than equal to 32 weeks .
Inborn neonates delivered at MCH, Kolkata.
Neonates receiving resuscitation with intact cord. 
 
ExclusionCriteria 
Details  1. Maternal HIV infection

2. Maternal Hepatitis B infection

3. Rh-negative pregnancy

4. Antepartum hemorrhage, including:

a. Placenta previa

b. Abruptio placentae

5. Mothers who do not provide informed consent

6. Major congenital anomalies

7. Cord complications such as:

a. Cord prolapse

7. True knot of the cord

8. Outborn neonates

9. Hydrops fetalis 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Decreased need of invasive or non invasive respiratory support.
 		 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Decreased incidence of retinopathy of prematurity.
2.Decreased incidence of intraventricular hemorrhage.
3.Decreased incidence of necrotising enterocolitis.
4.Decreased incidence of anemia.
5.Decreased incidence of late onset neonatal sepsis.
6.Decreased incidence of mortality. 		 3 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   20/10/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.dineshmunian@gmail.com].

  6. For how long will this data be available start date provided 14-10-2025 and end date provided 31-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This randomized controlled trial (RCT) aims to evaluate the outcomes of preterm neonates (<32 weeks gestation) undergoing intact cord resuscitation (ICR) compared to the current standard practice of immediate cord clamping during resuscitation. The study is being conducted in the Labour Room and EDEN OT of Medical College and Hospital, Kolkata. Eligible neonates are randomized into intervention and control groups. Primary outcomes include survival and short-term neonatal morbidities (e.g., respiratory distress, need for ventilation, intraventricular hemorrhage). Secondary outcomes assess adaptation parameters and early complications. The trial is designed to generate evidence on the feasibility and benefits of ICR in extremely preterm neonates, with the goal of improving neonatal survival and reducing complications. 
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