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CTRI Number  CTRI/2025/08/093590 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
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   Role of airway clearance for improving the stability of the babies who defecated in the womb and did not breathe at birth 
Scientific Title of Study   Endotracheal Suctioning versus No Suctioning for Postnatal Stabilization of Non-vigorous Neonates Born through Meconium Stained Liquor: 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  Poonam Singh 
Designation  Additional professor 
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Room no 016120, Block A, Medical College Building, Department of Neonatology, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8527106059  
Fax    
Email  drpoonamujn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Poonam Singh 
Designation  Additional professor 
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Room no 016120, Block A, Medical College Building, Department of Neonatology, All India Institute of Medical Sciences, Rishikesh


UTTARANCHAL
249203
India 
Phone  8527106059  
Fax    
Email  drpoonamujn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Arunpadiyan S 
Designation  Academic Senior Resident (DM Neonatology)  
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Room No 016121, Block A, Medical College Building, Department of Neonatology, All Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9487036961  
Fax    
Email  drarunpandiyan@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Rishikesh, Dehradun, Uttaranchal, India, 249203 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Rishikesh 
Address  All India Institute of Medical Sciences, Rishikesh, Virbharda road Pashulok, Dehradun, Uttaranchal, 249203  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Poonam Singh  Room no 016120, Block A, Medical College Building, Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, Dehradun, Uttaranchal, 249203  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Poonam Singh  All India Institute of Medical Sciences, Rishikesh   Room no 016120, Block A, Medical College Building, Department of Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL 		 8527106059

drpoonamujn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P288||Other specified respiratory conditions of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endotracheal suctioning  Non-vigorous neonates delivered through meconium stained liquor will undergo tracheal suctioning under direct laryngoscopy followed by initial steps of resuscitation within first minute of life. Subsequent steps will be performed as per NRP 2020 algorithm. 
Comparator Agent  No-endotracheal suctioning  Non-vigorous neonates delivered through meconium stained liquor will receive initial steps of resuscitation within first minute of life. Subsequent steps will be performed as per NRP 2020 algorithm. No-endotracheal suctioning will be done in controls.  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  90.00 Day(s)
Gender  Both 
Details  Non-vigorous singleton neonates of gestational age equal to or more than 34 weeks delivered through meconium stained liquor
 
 
ExclusionCriteria 
Details  1. Major congenital malformations
2. Refusal of consent 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Peripheral oxygen saturation   at 5 minutes of life 
 
Secondary Outcome  
Outcome  TimePoints 
A. Immediate
1. Minute-specific heart rate & peripheral oxygen saturation
2. Fraction of inspired oxygen & number of neonates requiring a 100% oxygen concentration
3. Need for & time to initiate positive pressure ventilation since birth
4. Incidences of procedure related adverse events

B. Early

1. Heart rate, respiratory rate, peripheral oxygen saturation, blood pressure & cerebral regional oxygen saturation
2. Incidence of respiratory distress
3. Need & duration of respiratory support
4. Incidence & severity of hypoxic ischemic encephalopathy
5. Death within 72-hours after randomization

C. Late
1. Morbidities during hospital stay
2. Final outcome
3. Duration of hospital stay
4. Hammersmith neonatal neurological examination at the time of discharge 		 at 10 minutes, 1 hour, 72 hours of life & discharge 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   10/09/2026 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drarunpandiyan@gmail.com].

  6. For how long will this data be available start date provided 20-06-2029 and end date provided 20-06-2032?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This study is a randomized, parallel group trial comparing the effect of endotracheal suctioning versus no suctioning on postnatal cardiorespiratory stability of non vigorous neonates delivered through meconium stained liquor at birth. The primary outcome measures will be mean peripheral oxygen saturation at five minutes of life. The secondary outcomes will be cardiorespiratory parameters and regional cerebral oxygen saturation at 10 minutes and 1 hour of life, need and duration of respiratory support, morbidities and mortality during hospital stay and neurological examination at discharge.
 
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