| CTRI Number |
CTRI/2025/09/095343 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of duration of placental transfusion on hemodynamic and oxygenation parameters in moderate to late-preterm neonates |
|
Scientific Title of Study
|
Effect of timing of cord clamping on hemodynamic and oxygenation parameters in moderate to late-preterm neonates |
| 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 Iffat Sultan |
| Designation |
Post Graduate resident |
| Affiliation |
|
| Address |
Department of Paediatrics,neonatal division,Vardhman Mahavir Medical college and Safdarjung Hospital
South
DELHI
110029
India |
| Phone |
8800532238 |
| Fax |
|
| Email |
iffatsultan1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep K Debata |
| Designation |
Professor and Head of Department,Vardhman Mahavir Medical College and Safdarjung Hospital |
| Affiliation |
|
| Address |
Department of Paediatrics, Neonatal division,Vardhman Mahavir Medical College and Safdarjung Hospital
South
DELHI
110029
India |
| Phone |
7291000664 |
| Fax |
|
| Email |
drpkdebata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep K Debata |
| Designation |
Professor and Head of Department,Vardhman Mahavir Medical College and Safdarjung Hospital |
| Affiliation |
|
| Address |
Department of Paediatrics,Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi
South
DELHI
110029
India |
| Phone |
7291000664 |
| Fax |
|
| Email |
drpkdebata@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari nagar,New Delhi-110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Iffat Sultan |
Vardhman mahavir medical colleg and safdarjung hospital |
Department of Paediatrics,neonatal Division,Vardhman mahavir medical college and safdarjung hospital,ansari nagar west,new delhi 110029
South
DELHI |
8800532238
iffatsultan1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,VMMC and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.01 Day(s) |
| Age To |
0.04 Day(s) |
| Gender |
Both |
| Details |
Moderate to late-preterm neonates (32-36+6) delivered at Safdarjung Hospital and not requiring any resuscitation at birth. |
|
| ExclusionCriteria |
| Details |
1. Major congenital malformations
2. Need of resuscitation at birth
3. Multiple gestation
4. Significant maternal/intrapartum complications (e.g., antepartum hemorrhage,
preeclampsia, chorioamnionitis, fetal distress, cord prolapse)
5.Cord accidents (tight nuchal cord, knots)
6. Non-availability of research team to record the findings |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Superior vena cava (SVC) Flow measured using functional echocardiography |
12 hours of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Echocardiographic parameters of systemic blood flow like Left ventricular output
(LVO), Superior mesenteric artery (SMA) Resistive Index (RI) and Anterior Cerebral
Artery (ACA) RI using functional echocardiography within 12-24 hours of life between
the study groups. |
12-24 hours of life |
| 2. Preductal Spo2, heart rate, PI and PVI at 1, 3, 5 and 10 minutes of life in the three groups. |
Till 10 minutes |
3. To compare the need of oxygen support, surfactant, phototherapy and exchange
transfusion between the study groups. |
Till Nicu stay |
4. To compare the incidence of intraventricular hemorrhage (IVH), necrotizing
enterocolitis (NEC), Sepsis, Patent Ductus Arteriosus (PDA), Retinopathy of
Prematurity (ROP), early neonatal death (END), in-hospital mortality, and need for
blood transfusion during the NICU stay across the study groups. |
Till Nicu stay |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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)
|
04/10/2025 |
| 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="1"
Months="6"
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [iffatsultan1111@gmail.com].
- For how long will this data be available start date provided 06-03-2028 and end date provided 06-03-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective observational study will be conducted after obtaining approval from the Institutional Ethics Committee and the Institute Review Board. The study will also be registered with the Clinical Trial Registry of India prior to initiation. Written informed consent will be obtained antenatally from pregnant women admitted for anticipated preterm delivery. Participants will be assured that their participation is voluntary and that they may withdraw at any time without affecting clinical care. All moderate to late preterm neonates meeting the inclusion criteria with gestational age of 32 weeks to 36 weeks plus 6 days, and born in the hospital who do not require resuscitation at birth will be enrolled in the study. All enrolled neonates will undergo delayed cord clamping as per the routine practices of the attending obstetric team. Based on the timing of cord clamping, neonates will be observed and categorized into one of three groups: • Early Cord Clamping : Cord clamped at less than 60 seconds • Short-duration delayed cord clamping 60 to 120 seconds, and • Extended-duration delayed cord clamping more than equal to 120 seconds. The timing of cord clamping will be documented using a standardized stopwatch protocol. Immediately after birth, prior to cord clamping, the neonate will be placed either on the mother’s abdomen or a sterile surface at the level of the placenta. A pulse oximeter with a neonatal probe will be applied to the neonate’s right wrist , and continuous monitoring will be done using a standardized pulse oximetry device to record: • Heart rate • Preductal oxygen saturation • Perfusion index • Pleth variability index These parameters will be recorded at 1 minute intervals from 1 to 10 minutes of life. To ensure accuracy in recording the exact time of cord clamping and the values of key physiological parameters, videographic recording of the monitor screen only will be done in all enrolled neonates. The recording will capture real-time values of perfusion index , pleth variability index , heart rate , and oxygen saturation during the immediate postnatal period. No part of the mother or the birthing field will be included in the video recording, thus ensuring complete privacy and dignity of the laboring mother. The video footage will be reviewed independently by two trained investigators for verification and extraction of time synchronized data. This approach will minimize observer bias and improve the accuracy and consistency of data collection. All neonates will receive routine postnatal care including early skin-to-skin contact and initiation of breastfeeding as per Essential Newborn Care protocols. A functional echocardiography will be performed by trained neonatologists within the first 12 to 24 hours of life using a standardized protocol. Parameters to be assessed include: • Superior Vena Cava flow • Left Ventricular Output • ACA PSV, RI • SMA PSV, RI Image acquisition and measurements will follow a standardized protocol aligned with international neonatal echocardiography guidelines. A second blinded reviewer will independently analyse all the scans to assess interobserver variability.Additional clinical and demographic data including gestational age, birth weight, gender, APGAR scores, mode of delivery, and relevant antenatal risk factors will be collected using a pre-designed and validated case record form. Routine neonatal management will continue as per unit protocol without interference from the study procedures. |