FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068544 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 13/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Diagnostic
Process of Care Changes 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   This is a study on newborn babies to find out if delay in cord clamping, or cod milking at birth, could help the baby in short term out come over a period of 3 months after birth.  
Scientific Title of Study   Comparison of effects of three umbilical cord management strategies on mean haemoglobin levels and other neonatal outcomes: A Single Centre Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Anthwal 
Designation  Assistant Professor 
Affiliation  Jagannath Gupta Institute of Medical Sciences 
Address  Jagannath Gupta Institute of Medical Sciences, Budge budge, Kolkata

Kolkata
WEST BENGAL
700037
India 
Phone  09433666809  
Fax    
Email  poojaanthwal2010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pooja Anthwal 
Designation  Assistant Professor 
Affiliation  Jagannath Gupta Institute of Medical Sciences 
Address  Room no 6,4th floor, dept of paediatrics , Jagannath Gupta Institute of Medical Sciences, Budge budge, Kolkata

Kolkata
WEST BENGAL
700037
India 
Phone  09433666809  
Fax    
Email  poojaanthwal2010@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pooja Anthwal 
Designation  Assistant Professor 
Affiliation  Jagannath Gupta Institute of Medical Sciences 
Address  Room no 6, 4th floor, Dept pf paediatrics, Jagannath Gupta Institute of Medical Sciences, Budge budge, Kolkata.

Kolkata
WEST BENGAL
700037
India 
Phone  09433666809  
Fax    
Email  poojaanthwal2010@gmail.com  
 
Source of Monetary or Material Support  
Jagannath Gupta Institute of Medical Sciences, KP Mondal Road, Buita, Budge budge, Kolkata, West Bengal India, Pin 700137 , 
 
Primary Sponsor  
Name  Jagannath Gupta Institute of Medical Sciences 
Address  Budge budge, Kolkata, India. PIN 70017 
Type of Sponsor  Private medical college 
 
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 
pooja anthwal  Jagannath Gupta Institute of Medical Sciences  Budge budge, Kolkata, India. PIN 70017
Kolkata
WEST BENGAL 		 09433666809

poojaanthwal2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE (HUMAN STUDIES)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  TERM HEALTHY NEWBORN 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cord milking  Cord milking without any delay, to achieve certain benefits, is the newer recommended method of cord care at birth. 
Intervention  Delayed cord clamping   Delayed cord clamping by 30-60 seconds, which is the newer recommended method of care, to achieve certain benefits. 
Comparator Agent  Early cord clamping  Early cord clamping is the traditional method of cord care, which might not be beneficial to the baby, as per recent studies. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  5.00 Day(s)
Gender  Both 
Details  Singleton vigorous newborns born at 32 (0/7) to 41 (6/7) weeks of gestation from largely uncomplicated pregnancies.
 
 
ExclusionCriteria 
Details  newborns requiring resuscitation, multiple gestations, congenital anomalies, placental abnormalities, alloimmunization, foetal hydrops, fetal compromise, and maternal illness affecting foetal well-being.  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM)

Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life.
Frequency of IVH
Frequency of NEC
Frequency of neonatal hyperbilirubinemia
Incidence of phototherapy
Length of stay after birth.

Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation
 		 Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM)

Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life.
Frequency of IVH
Frequency of NEC
Frequency of neonatal hyperbilirubinemia
Incidence of phototherapy
Length of stay after birth.

Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life.
Frequency of IVH
Frequency of NEC
Frequency of neonatal hyperbilirubinemia
Incidence of phototherapy
Length of stay after birth.

Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation  		 At day 3 of life and 3 months of age 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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   Phase 4 
Date of First Enrollment (India)   25/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data would be sent to the editors of the journal publication through proper channel.

  6. For how long will this data be available start date provided 20-05-2025 and end date provided 20-06-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a single centre randomised controlled trial including newborn from day 0 to 3 months of age to see how the outcome changes depending on the cord clamp management. Singleton babies delivered at 32(0/7) to 41(6/7) weeks gestation, from uncomplicated pregnancy, vigorous at birth divided into three groups ,25 babies in each group, total 75 babies. Three groups are 1. early cord clamping without milking, 2. delayed cord clamping with milking, 3. delayed cord clamping without milking. Exclusion criteria being newborn requiring resuscitation, congenital anomalies, IUGR, multiple gestation, placental anomalies, alloimmunisation, foetal hydrops. Primary outcome would be mean haemoglobin at 72 hours of life. Other outcome would be frequency of IVH, NEC, hyperbilirubinemia, need for phototherapy, NICU admission, shock, mechanical ventilation and duration of stay in the hospital. 
Close