| CTRI Number |
CTRI/2026/02/104823 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| 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
|
A research study comparing umbilical cord clamping at 1 minute versus 2 minutes after birth and its effect on red blood cell mass in growth restricted babies born at or after 28 weeks of gestational age |
|
Scientific Title of Study
|
Effect of cord clamping at 120 ±10 seconds vs 60 ± 10 seconds on postnatal haematological status among neonates more than or equal to 28 weeks gestation with estimated fetal weight less than 10th centile: A parallel group randomized 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 |
Soma Sengupta |
| Designation |
Senior Resident Academic |
| Affiliation |
AIIMS Patna |
| Address |
Department of Neonatology, IPD Building, BGA Block, AIIMS Patna, Phulwarisharif, Patna
Patna
BIHAR
801507
India |
| Phone |
7557884093 |
| Fax |
|
| Email |
somasengupta121116@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bhabesh Kant Chowdhry |
| Designation |
Head of Department and Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Neonatology, IPD Building, BGA Block, AIIMS Patna, Phulwarisharif, Patna
Patna
BIHAR
801507
India |
| Phone |
7871592369 |
| Fax |
|
| Email |
drbhabeshkc@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Bhabesh Kant Chowdhry |
| Designation |
Head of Department and Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Neonatology, IPD Building, BGA Block, AIIMS Patna, Phulwarisharif, Patna
Patna
BIHAR
801507
India |
| Phone |
7871592369 |
| Fax |
|
| Email |
drbhabeshkc@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| AIIMS Patna, Phulwarisharif,
Patna, Bihar, India.
Pin: 801507 |
|
|
Primary Sponsor
|
| Name |
Soma Sengupta |
| Address |
Department of Neonatology, IPD Building, BGA Block, AIIMS Patna, Phulwarisharif, Patna, Bihar.
Pin:801507 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Soma Sengupta |
Labour room, OT, Level III NICU (B1A Block) and Post-natal ward (B1B block), IPD building |
AIIMS Patna, Phulwarisharif, Patna, Bihar, India.
Pin: 801507
Patna
BIHAR |
7557884093
somasengupta121116@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Estimated fetal weight less than 10th centile on ultrasound |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Umbilical cord clamping |
Umbilical cord clamping at 1 minutes of post-natal age |
| Intervention |
Umbilical cord clamping |
Umbilical cord clamping at 2 minutes of post-natal age |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Neonates of gestational age more than 28 weeks to 42 weeks of gestation with estimated fetal weight less than 10th percentile for gestation by ultrasound |
|
| ExclusionCriteria |
| Details |
Neonates born to mothers with hemodynamic instability, placenta previa/abruptio placentae
Multi fetal gestation
Major congenital malformation
Fetal hydrops
Requiring resuscitation at birth
Maternal isoimmunization
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hematocrit |
At 48 Hours of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of polycythemia |
At 48 hours of life |
| Polycythemia requiring partial exchange |
At 48 hours of life |
| Vital parameters (Heart Rate, Mean arterial pressure, Respiratory rate, Temperature) |
At 1 & 2 hours of birth |
| Incidence of Neonatal Hyperbilirubinemia requiring phototherapy or exchange transfusion |
Within 72 hours of birth |
| Serum ferritin |
At 6 weeks of post-natal age |
| Incidence of PPH in mother |
Within 24 hours of delivery |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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="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
|
A prospective interventional study will be done at a tertiary care hospital involving newborns born at 28 weeks to 42 weeks of gestational age with estimated fetal weight of less than 10th centile, studying the effect of cord clamping at 1 minute versus 2 minutes of post-natal life and its effect on hematocrit at 48 hours of life. |