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CTRI Number  CTRI/2024/11/076625 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 11/11/2024
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   Delayed cord clamping at two different time points in healthy premature newborns and its effect on oxygen saturation  
Scientific Title of Study   Physiological Versus One-Minute Based Delayed Cord Clamping Among Very and Moderate Preterm Infants Not Requiring Resuscitation: A 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  Dr Neeraj Gupta 
Designation  Professor, Department of Neonatology 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  3rd Floor, Academic block, Department of Neonatology, All India Institute of Medical Sciences, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996908  
Fax    
Email  neerajpgi@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Neeraj Gupta 
Designation  Professor, Department of Neonatology 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  3rd Floor, Academic block, Department of Neonatology, All India Institute of Medical Sciences, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996908  
Fax    
Email  neerajpgi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Gudipudi Sai Vamsi Manoj 
Designation  DM Resident, Department of Neonatology 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  3rd Floor, Academic block, Department of Neonatology, All India Institute of Medical Sciences, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9348248118  
Fax    
Email  manoj.gsv2397@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur, Rajasthan, India, 342005 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  Academic Block Building, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Neeraj Gupta  All India Institute of Medical Sciences, Jodhpur  Department of Neonatology and Department of Obstetrics and Gynaecology, 2nd floor Hospital building, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India, 342005
Jodhpur
RAJASTHAN 		 8003996908

neerajpgi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,All India Institute of Medical Sciences,Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Very and Moderate Preterm Infants born in AIIMS Jodhpur 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  One-minute-based Delayed Cord Clamping  Preterm infants (28+0-33+6 weeks) born by vaginal or Caesarean delivery and not requiring resuscitation, the cord will be clamped after one minute of preterm infant birth time. The study is aimed at evaluating the time taken to reach 90% oxygen saturation.  
Intervention  Physiological-based Cord Clamping  Preterm infants (28+0-33+6 weeks) born by vaginal or Caesarean delivery and not requiring resuscitation, the cord will be clamped after separation of the placenta (Caesarean section: Placental separation is noted by gush of the blood and placenta coming out of the incision Vaginal delivery: Placental separation is noted when the placenta has descended into the vagina with a gush of blood and lengthening of the cord. The study is aimed at evaluating the time taken to reach 90% oxygen saturation.  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  4.00 Month(s)
Gender  Both 
Details  Very and moderate preterm (28+0–33+6 weeks) singleton pregnancy or multifetal gestation (only dizygotic pregnancy) with anticipated delivery irrespective of the mode of delivery, i.e., vaginal and LSCS, either elective or emergency. (Gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available.) 
 
ExclusionCriteria 
Details  1. Multifetal gestation (Other than Dizygotic pregnancy)
2. Suspected or confirmed congenital anomaly or syndrome in the fetus
3. Neonates with major congenital malformation or having syndromic appearance noted at birth
4. Neonates requiring resuscitation immediately after birth.
5. Neonates where PBCC could not be practiced due to any maternal or neonatal reason. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the time to reach 90% preductal oxygen saturation (SpO2) among very and moderate preterm infants (28+0-33+6weeks) who do not require resuscitation and underwent physiological-based cord clamping (PBCC) compared to one-minute-based
delayed cord clamping (DCC) 		 Time taken to reach 90% preductal oxygen saturation  
 
Secondary Outcome  
Outcome  TimePoints 
To compare heart rate, saturation till 10 minutes of life and Expanded Apgar score at 1, 5, and 10 minutes of life.  Till 10 minutes of life 
To study difference in hematocrit levels at 24(±4) hours among very and moderate preterm infants (28+0-33+6 weeks).  24(±4) hours 
Incidence of respiratory distress, need of CPAP alone, mechanical ventilation, and fluid bolus or inotropic support in the first 48 hours of life.  First 48 hours of life 
Incidence of polycythemia and jaundice requiring treatment with phototherapy or exchange transfusion, or both till discharge, need of blood transfusion during hospital stay  Till discharge of patient  
To compare the hematological parameters like hemoglobin, MCV, MCHC, Reticulocyte count and Peripheral smear at 4 (±1) weeks of life.  4(±1) weeks of life 
To compare incidence of neonatal in-hospital morbidities like IVH (any grade and severe IVH), NEC (any stage and definite NEC), PVL, BPD, PDA requiring treatment, Sepsis (Culture negative and culture positive, early onset and late onset), ROP (any stage), and ROP requiring treatment.  Till Discharge of patient 
To compare in-hospital mortality among both groups.  Till In-hospital stay 
Maternal Postpartum haemorrhage   Within 24 hours after birth 
Maternal in-hospital mortality, need of blood transfusion and ICU admission post-delivery till discharge  Till Discharge 
 
Target Sample Size   Total Sample Size="182"
Sample Size from India="182" 
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 3 
Date of First Enrollment (India)   22/11/2024 
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="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  

We propose that the timing for clamping the umbilical cord should be individualized for each mother-infant pair rather than adhering to a fixed time frame. This is because placental transfusion continues until the placenta separates from the uterus. Therefore, the optimal time for delayed cord clamping (DCC) may be when the placenta has naturally separated, referred to as physiological-based cord clamping (PBCC). However, there is a lack of data comparing neonatal outcomes between delayed cord clamping and physiological-based cord clamping (defined as clamping after placental separation) in healthy very and moderately preterm infants. Many studies have assessed outcomes such as infant hemoglobin levels, iron status, ferritin levels, jaundice, need for phototherapy, necrotizing enterocolitis, and intraventricular hemorrhage in preterm infants, comparing early and delayed cord clamping. Nonetheless, there are limited studies that specifically compare these outcomes between delayed and physiological cord clamping in preterm births.


Population- Very and moderate preterm (28+0-33+6) infants not requiring resuscitation

Intervention- Clamping the cord after separation of the placenta (Caesarean section:Placental separation is noted by gush of the blood and placenta coming out of the incision; Vaginal delivery: Placental separation is noted when the placenta has descended into the vagina with gush of blood and lengthening of the cord)

Control- Clamping cord at 60 seconds

Outcome- 90% preductal oxygen saturation (SpO2)

Time- Time till 90% preductal oxygen saturation (SpO2) is attained


Research Question- What is the time to reach 90% preductal oxygen saturation (SpO2) among very and moderate preterm infants (28+0-33+6 weeks) who do not require resuscitation, and underwent physiological-based cord clamping (PBCC) compared to one-minute based delayed cord clamping (DCC)?


 
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