| 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
|
|
|
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
|
|
|
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 underâ€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 selfâ€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 “awakeâ€
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 burnsâ€. 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
placeboâ€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 nonâ€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. |