| 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
|
|
|
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
|
|
|
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. |