| CTRI Number |
CTRI/2026/01/102068 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of umbilical cord clamping time on jaundice in preterm babies. |
|
Scientific Title of Study
|
Effect of timing of umbilical cord clamp on neonatal jaundice in preterm neonates, a randomized control 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 |
Navratan Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
LLRM medical college, Meerut |
| Address |
Room number 15, Department of Paediatrics,LLRM Medical College
Room number 15, Department of Paediatrics,LLRM Medical College
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9457660060 |
| Fax |
|
| Email |
navratankumargupta9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Navratan Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
LLRM medical college, Meerut |
| Address |
Room number 15, Department of Paediatrics,LLRM Medical College
Room number 15, Department of Paediatrics,LLRM Medical College
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9457660060 |
| Fax |
|
| Email |
navratankumargupta9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Navratan Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
LLRM medical college, Meerut |
| Address |
Room number 15, Department of Paediatrics,LLRM Medical College
Room number 15, Department of Paediatrics,LLRM Medical College
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9457660060 |
| Fax |
|
| Email |
navratankumargupta9@gmail.com |
|
|
Source of Monetary or Material Support
|
| LLRM Medical College,Meerut
250004 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
A 16 Takshila colony, Meerut
250004 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sinthiya Goyal |
Lala Lajpat Rai Memorial Medical College |
Neonatal intensive care unit,2nd floor, ward no. 18 Department of Paediatrics
Meerut
UTTAR PRADESH |
9599173781
sinthiyapg23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF LALA LAJPAT RAI MEDICAL COLLEGE MEERUT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hemodynamically stable preterm newborns |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Serum Bilirubin |
Comparing serum bilirubin levels in early cord clamp and delayed cord clamp |
| Intervention |
Timing of umbilical cord clamp |
Early that is less than 1 min vs delayed cord that is more than 1 min of timing of umbilical cord clamping |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
All preterm babies delivered via normal vaginal delivery an caesarean delivery |
|
| ExclusionCriteria |
| Details |
Babies born to mecounium stained liquor
Twin delivery
Babies of RH negative mothers
Babies born with congenital anomalies
Cord prolapse |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare serum bilirubin levels in early cord clamp group and late cord clamp group |
To compare serum bilirubin levels in both groups on 3 day of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
05/02/2026 |
| 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) |
Open to Recruitment |
|
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
|
To compare levels of serum bilirubin in early cord clamping and delayed cord clamping in preterm newborns delivered before 37 weeks of gestation via normal vaginal delivery or caesarean section.Samples for serum bilirubin will be collected in both groups and compared for serum bilirubin levels on 3 day of life |