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CTRI Number  CTRI/2024/10/075751 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [DELAYED CORD CLAMPING]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Delayed umbilical cord clamping at 1 minute versus 3 minutes in early born newborns and its effect on hematological parameters 
Scientific Title of Study   Delayed cord clamping(DCC) at 1 minute versus 3 minutes in preterm neonates: A randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BIJAN SAHA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Associate Professor 
Address  DEPARTMENT OF NEONATOLOGY IPGMER AND SSKM HOSPITAL KOLKATA Kolkata WEST BENGAL 700020 India

Kolkata
WEST BENGAL
700020
India 
Phone  9051389120  
Fax    
Email  bijansaha18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  BIJAN SAHA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Associate Professor 
Address  DEPARTMENT OF NEONATOLOGY IPGMER AND SSKM HOSPITAL KOLKATA Kolkata WEST BENGAL 700020 India

Kolkata
WEST BENGAL
700020
India 
Phone  9051389120  
Fax    
Email  bijansaha18@gmail.com  
 
Details of Contact Person
Public Query  
Name  BIJAN SAHA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Associate Professor 
Address  DEPARTMENT OF NEONATOLOGY IPGMER AND SSKM HOSPITAL KOLKATA Kolkata WEST BENGAL 700020 India

Kolkata
WEST BENGAL
700020
India 
Phone  9051389120  
Fax    
Email  bijansaha18@gmail.com  
 
Source of Monetary or Material Support  
NOT APPLICABLE 
 
Primary Sponsor  
Name  IPGMER AND SSKM HOSPITAL 
Address  244 AJC BOSE ROAD KOLKATA WEST BENGAL 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
DEPARTMENTAL FUNDING  DEPARTMENT OF NEONATOLOGY IPGMER AND SSKM HOSPITAL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SAUGATO CHOUDHURI  IPGMER AND SSKM HOSPITAL  NICU DEPARTMENT OF NEONATOLOGY
Kolkata
WEST BENGAL 		 9477036563

saugata.dr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PLACENTAL TRANSFUSION 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DELAYED CORD CLAMPING AT 1 MINUTES  he intervention done is delayed clamping of the umbilical cord at two different timings (60 s or 180 s of delivery) as allocated after randomization. As per allocation to respective arms , the obstetrician shall clamp and cut the umbilical cord after 1 minute and 3 minutes of delivery respectively. A properly functioning wall- mounted clock shall be present in the delivery room for accurately noting down the timings. Neonates born vaginally will be kept over the mother’s abdomen prior to cord clamping and neonates born by cesarean section were placed between the mother’s thighs before cord clamping. 
Intervention  DELAYED CORD CLAMPING AT 3 MINUTES  The intervention done is delayed clamping of the umbilical cord at two different timings (60 s or 180 s of delivery) as allocated after randomization. As per allocation to respective arms , the obstetrician shall clamp and cut the umbilical cord after 1 minute and 3 minutes of delivery respectively. A properly functioning wall- mounted clock shall be present in the delivery room for accurately noting down the timings. Neonates born vaginally will be kept over the mother’s abdomen prior to cord clamping and neonates born by cesarean section were placed between the mother’s thighs before cord clamping.  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  1. Inborn neonates 300/7 to 366/7 weeks of gestation
2. Written informed parental consent obtained before participation in the study
 
 
ExclusionCriteria 
Details  i. Neonates born at gestation less than 30 weeks or more than or equal to 37 weeks
ii. Outborn neonates
iii. Multiple gestation
iv. Major lethal congenital anomalies or known/suspected chromosomal anomalies
v. Fetal hydrops
vi. Rh isoimmunization
vii. Cord prolapse, cord abnormalities such as true knots
viii. Shortumbilical cordlength
ix. No parental consent
x. Residence beyond 20 kms radius from our unit.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine venous hematocrit  AT 48 HOURS OF LIFE 
 
Secondary Outcome  
Outcome  TimePoints 
a. Hct at 6 weeks of postnatal age
b. Bilirubin level at 12 , 48 hours of postnatal age.
c. Serum ferritin at 6 wks of age
d. Heart rate, mean blood pressure in the first 48 hours of life
e. Hyperbilirubinemia requiring phototherapy
f. Symptomatic polycythemia in first 48 hours
g. Incidence of hemodynamically significant patent ductus arteriosus,NEC (Stage 2 and above), IVH on cranial ultrasound(grade3andabove), ROP(stage2andabove) and BPD
h. Total number of PRBC transfusions till 6 weeks of postnatal age
i. Duration of hospital stay
j. Death up to 6weeks of postnatal age
 		 12 hours,48 hours and at 6 weeks of life 
 
Target Sample Size   Total Sample Size="304"
Sample Size from India="304" 
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)   04/11/2024 
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="11"
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  

BACKGROUND

A newborn experiences a variety of unique challenges at birth.  Significant cardiovascular changes occur and this transition in hemodynamics from fetal to extrauterine life is a vital phase in the early days of life. An increase in the   amount of newborn hemoglobin (Hb) and blood volume achieved through placental transfusion has the potential to improve cardiac output and tissue oxygen delivery during this critical period. Placental transfusion therefore has recently gained much importance. It involves the transfer of left over placental blood to the newborn baby during the initial minutes of life. There are three techniques to achieve this: delayed cord clamping (DCC), intact umbilical cord milking (I-UCM), and cut umbilical cord milking (C-UCM). Different placental transfusion strategies has shown to have significant  and hematological benefits in this vital period and beyond.


Despite being recommended as a routine practice, there are  concerns about the potentially harmful effects of DCC on neonatal and maternal outcomes such as higher incidences of polycythemia, neonatal hyperbilirubinemia (NNH), and the need for phototherapy, and postpartum hemorrhage in mothers with low certainty of evidence. However the systematic reviews evaluating these risks had low certainty of evidence owing to different methodologies of individual studies .

Therefore, to decide a uniform timing for cord clamping, and thus establish the optimal definition of DCC, more evidence needs to be generated. There is biological plausibility that the extra blood transfused by extending the time of  DCC upto 3 minutes would result in improved hematological parameters  and better neonatal transition. Limited number of studies are available in near term and term infants but  there is paucity  of data in preterm infants.

PURPOSE OF THE STUDY


·       Despite the reported benefits of  DCC,  the literature is scanty regarding the timing of delayed cord clamping .

·       No consensus exists as of now on the optimal cord clamping timing while practising delayed cord clamping  and more so in preterm neonates.

 

In view of lack of consensus regarding optimal timing of DCC and scarcity of similar data in preterm infants from low- and middle-income countries (LMICs). , this study is designed to compare DCC for 1 minute versus 3 minutes with regards to hematological and clinical hemodynamic parameters in preterm neonates of 30-37 weeks gestation. 

 

We hypothesize that DCC for 3 minutes will lead to higher serum hematocrit at 48 hrs of age compared to DCC for 1 min  in neonates of 30-37 weeks gestation 



 
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