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CTRI Number  CTRI/2024/05/066746 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To assess pain and discomfort and use measures to decrease pain during surfactant administration in premature babies 
Scientific Title of Study   Pain assessment and management using nonpharmacological measures during surfactant administration by LISA vs INSURE technique 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  John Biswas  
Designation  Senior resident 
Affiliation  Government medical college Chh. Sambhajinagar 
Address  Department of neonatology Government medical college Chh.Sambhajinagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  9532102045  
Fax    
Email  biswas.j91@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Laxmikant Deshmukh 
Designation  Professor and Head 
Affiliation  Government medical college,Chh. Sambhajinagar 
Address  Department of neonatology Government medical college Chh.Sambhajinagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  9822478275  
Fax    
Email  deshmukhls@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  John Biswas 
Designation  Senior resident 
Affiliation  Government Medical college, Chh. Sambhajinagar 
Address  Department of Neonatology Government medical colledge Chh. Sambhajinagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  9532102045  
Fax    
Email  biswas.j.91@gmail.com  
 
Source of Monetary or Material Support  
Department of neonatology Government medical college Chh. Sambhajinagar- 431001 Maharashtra, India 
 
Primary Sponsor  
Name  Department of Neonatology Government medical College Chh Sambhajinagar  
Address  Department of neonatology casualty building 2nd floor Government medical college,Chh Sambhajinagar 431001 Chh.Sambhajinagar, 
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 
John Biswas  Government medical college Chh.Sambhajinagar  Department of neonatology Government medical college Chh.Sambhajinagar
Aurangabad
MAHARASHTRA 
9532102045

biswas.j.91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVT. MEDICAL COLLEGE AURANGABAD   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  14.00 Day(s)
Gender  Both 
Details  All babies of GA less than 37 weeks with diagnosis of RDS requiring surfactant therapy with either LISA or INSURE methods. 
 
ExclusionCriteria 
Details  1. Intubation before the study entry
2. Perinatal asphyxia
3. IVH more than grade II
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess Pain profile during surfactant therapy with either LISA or INSURE method in preterm neonates diagnosed with RDS   1 Before surfactant administration
2 During laryngoscopy
3 During surfactant administration
4 After the procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Adequacy of analgesia  During surfactant therapy 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   15/05/2024 
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)  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  

         Historically, pain in newborn babies has been under‐recognized and, consequently undertreated. It was not until the late 1980s that seminal studies of babies undergoing surgery convincingly demonstrated that even preterm neonates are sufficiently developed, both anatomically and physiologically, to experience and respond to noxious stimuli. Moreover, these studies showed that the responses to noxious stimuli could be attenuated by the use of anesthesia and analgesia. Prior to this, infants had been, for many years, subjected to major surgery with no, or minimal anesthesia and without postoperative analgesia. Still, it is probably fair to say that clinicians were slow to take this message on board.

There has been ongoing debate about whether receiving mechanical ventilation is a painful experience, but what is not any longer questioned is that the process of endotracheal intubation is painful and stressful. We cannot know exactly how infants subjectively perceive pain; the lack of self‐report in preverbal infants means that we can only extrapolate from information available to us about how older individuals experience different procedures. Endotracheal intubation is rarely performed in adults without the aid of analgesia and/or sedative medication. However, there are reports of necessary “awake” intubations in adults. Such a report describes the patient’s experience of the procedure: “It felt like I could not swallow, like I would suffocate on the fluid, like as I cough and throw up at the same time and then it burns”. This graphic description leaves the reader in no doubt that the procedure can be unpleasant. Neonates were routinely subjected to airway management and intubation without sedative drugs until relatively recently. A number of research studies have considered the use of premedication for intubation in the newborn population. A retrospective review found that the use of premedication facilitated intubation for operators of all levels of experience. 7 Randomized placebo‐controlled trials are few and have enrolled only small numbers of babies. Results are conflicting, with some demonstrating fewer attempts and reduced time to intubate with premedication, and another unable to show no benefit with the use of morphine versus placebo. There have also been multiple studies comparing different drugs and combinations of drugs that have not included a placebo group. While acknowledging the limitations in evidence and gaps in knowledge in this area, premedication has long been recommended for neonates undergoing intubation in all but emergency situations.

It had taken many years of research and education to reach a stage where the majority of neonatal units in developed countries had adopted the routine use of premedication for intubation, although practice has been varied with respect to the medication used. However, in recent years, manipulation of the airway in “awake” preterm neonates is again becoming accepted practice. How can this be, when evidence has pointed to better outcomes with the use of premedication? Less invasive surfactant administration (LISA) (also sometimes referred to as minimally invasive surfactant therapy (MIST)) has started to be used more readily, with more and more units adopting this approach. This involves the insertion of a fine catheter through the vocal cords of a spontaneously breathing infant, usually while maintaining noninvasive respiratory support during the procedure. Surfactant is administered through this catheter, which is removed immediately after to allow the baby to continue non‐invasive respiratory support. With the advent of this type of procedure, controversy has once again arisen around the concept of giving sedation and analgesia. Revised Premature infant pain profile( PIPP-R) is used routinely in assessment of pain during procedures in preterm neonates routinely which is valid and feasible.

 
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