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CTRI Number  CTRI/2024/01/061862 [Registered on: 25/01/2024] Trial Registered Prospectively
Last Modified On: 16/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [RESUSCITATION BASED ON HEART RATE]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intact cord resuscitation using heart rate as a primary driver versus standard resuscitation among vaginally born term and late preterm infants requiring resuscitation - A randomized control trial 
Scientific Title of Study   Intact cord resuscitation using heart rate as a primary driver versus standard resuscitation among vaginally born term and late preterm infants requiring resuscitation - 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  DR NEERAJ GUPTA 
Designation  PROFESSOR 
Affiliation  AIIMS JODHPUR 
Address  DR NEERAJ GUPTA, PROFESSOR DEPARTMENT OF NEONATOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCE, JODHPUR

Jodhpur
RAJASTHAN
342004
India 
Phone  8003996908  
Fax    
Email  neerajpgi@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  DR NEERAJ GUPTA 
Designation  PROFESSOR 
Affiliation  AIIMS JODHPUR 
Address  DR NEERAJ GUPTA, PROFESSOR DEPARTMENT OF NEONATOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCE, JODHPUR

Jodhpur
RAJASTHAN
342004
India 
Phone  8003996908  
Fax    
Email  neerajpgi@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  ANURAG PANDEY 
Designation  DM RESIDENT 
Affiliation  AIIMS JODHPUR 
Address  DR ANURAG PANDEY, DM RESIDENT DEPARTMENT OF NEONATOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCE, JODHPUR

Jodhpur
RAJASTHAN
342004
India 
Phone  8826043910  
Fax    
Email  anuragpandey1980@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCE, JODHPUR 
 
Primary Sponsor  
Name  Aiims jodhpur 
Address  ALL INDIA INSTITUTE OF MEDICAL SCIENCE, JODHPUR 
Type of Sponsor  Government medical college 
 
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 ANURAG PANDEY  LABOR ROOM  TERTIARY CARE HOSPITAL, AIIMS JODHPUR, DEPARTMENT OF NEONATOLOGY ALONG WITH THE DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, JODHPUR AIIMS JODHPUR
Jodhpur
RAJASTHAN 
08826043910

anuragpandey1980@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, AIIMS , JODHPUR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P84||Other problems with newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Resuscitating new-born primary based on continuous HR monitoring with intact cord resuscitation  THIS STUDY is aimed at neonates requiring resuscitation based on birth among vaginally born term and preterm and need of positive pressure ventilation as compared with resuscitation based upon standard NRP 
Comparator Agent  Resuscitating new-born primary based on standard NRP 2020 recommendation  THIS STUDY is aimed at neonates requiring resuscitation based on birth among vaginally born term and preterm and need of positive pressure ventilation as compared with resuscitation based upon Primary HR driven resuscitation  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  More than or equal to 35 weeks POG singleton pregnancy with anticipated vaginal delivery (Gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available) 
 
ExclusionCriteria 
Details  1. Delivery by elective or emergency caesarean section
2. Multiple gestation
3. Antenatally detected life-threatening condition of fetus (e.g., severe hydrops, lethal chromosomal abnormality, severe congenital malformation)
4. Complete placental abruption, Placenta Previa
5. Use of Assisted Reproductive Technology like In Vitro Fertilization
After birth
1. Any condition (eg. cord tightly around the neck) necessitating immediate cord clamping and cord cutting based on obstetrics or neonatologist concern
2. Major congenital abnormalities or syndromic infant





 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of positive pressure ventilation among the two group  First 10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1. Need for intubation between the two groups

 
10 minutes 
Need for chest compression between the two groups  10 minutes 
3. In-hospital mortality between the two groups.
4. To compare the difference in APGAR score at 1,5 and 10 minutes between two grou
 
10 minutes 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   30/01/2024 
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 Yet Recruiting 
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  

Asphyxia in the peripartum period of the fetus is a burden accounting for one in fifths of all neonatal deaths and tenth of under 5 mortalities.1 In India, perinatal asphyxia accounts for 28.8 % mortality in infant period .   Advent of evidence-based perinatal medicine and neonatology has led to a clear understanding of the transitional physiology, of the phenomenon that is called “parturition “.The transition from intrauterine to extrauterine life at birth relies on major physiological changes. These changes include clearing of liquid from the distal lung to allow gas- exchange, increasing pulmonary blood flow by decreasing pulmonary vasculature resistance and increasing systemic vascular resistance, cessation of umbilical venous return, occlusion for various fetal shunt, and increasing oxygen saturation.

Although most ( 85%) infants initiate spontaneous breathing within the first 10 to 30s of birth, with an additional 10% responding during drying and stimulation, 3- 5% will initiate respirations after positive-pressure ventilation (PPV), with rest requiring further advanced support.

Initiation of PPV during resuscitation is primarily based on breathing effort or heart rate as defined by NRP 2020 in infants who fail to achieve spontaneous breathing within 1 minutes of birth (compromised infant). However, Recent recommendations from the American Academy of Pediatrics (AAP 2015) and the International Liaison Committee of Resuscitation (ILCOR 2015) state the importance of heart rate (HR) as the most vital of vital signs during the neonatal transition and/or resuscitation. Since obtaining a reliable continuous heart rate in the initial one minutes may be tedious work, resuscitation in the initial one minutes is primarily based on breathing efforts or a single HR obtained by auscultation along the left side of heart. 

Furthermore, during resuscitation, an increase in the infant’s heart rate is regarded as the most sensitive indicator of a successful response to the interventions required. Therefore, finding a fast, reliable, and precise method to measure the infant’s heart rate is crucial. 

HR also helps in differentiating the primary apnea from secondary apnea which is important for resuscitation as primary apnea responds to initial stimulation whereas secondary apnea is associated with the need of PPV and delaying PPV can result in brain injury in asphyxiating infants.

Until now, measuring fast and reliable heart rate within the initial 60 seconds of birth is often difficult with several studies have demonstrated that HR by auscultation, palpation and pulse oximetry were inaccurate. 

However, newer novel technologies are currently under evaluation to overcome this limitation with the most promising results from dry ECG electrode methods to capture HR within an initial 1 minute.

 While the availability of an earlier, more accurate HR with newer techniques like dry electrodes would seem useful on the surface, it has not been established whether this information has an impact on the timing or initiation of different resuscitation interventions and its usefulness to initiate timely resuscitation in infants with intact cord  (ICR).

Therefore, we proposed to conduct an RCT to demonstrate whether using HR as the primary driver can rationalize resuscitation in vaginally born more than or equal to 35 weeks new-born with ICR.

 
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