| CTRI Number |
CTRI/2024/04/065937 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [Procedural Analgesia] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Preventing procedural pain in preterm infants during Retinopathy of Prematurity screening. |
|
Scientific Title of Study
|
Procedural analgesia for pain during retinopathy of prematurity screening in preterm infants: A Multi-arm, Parallel group, Randomized Controlled trial comparing Multisensory stimulation, oral paracetamol, and control |
| 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 Mounika B |
| Designation |
PG Student |
| Affiliation |
Instiute of Child Health and Hospital for Children, Madreas Medical College. |
| Address |
Department of Neonatology, ICH and HC, Madras Medical College, Tamil Salai, Egmore, Chennai-600008
Department of Neonatology, ICH and HC, Madras Medical College, Tamil Salai, Egmore, Chennai-600008
Chennai
TAMIL NADU
600008
India |
| Phone |
8123705285 |
| Fax |
|
| Email |
mounabhaskarnaidu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAMALARATNAM C N |
| Designation |
Professor of Neonatology |
| Affiliation |
Institute of Child Health and Hospital for Children, Madras Medical College, Chennai |
| Address |
Department of Neonatology, A-Block, 1st floor, ICH & HC, Egmore
Tamil Salai
Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
9841102746 |
| Fax |
|
| Email |
drkamal.rathnam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KAMALARATNAM C N |
| Designation |
Professor |
| Affiliation |
Institute of Child Health and Hospital for Children, Madras Medical College, Chennai |
| Address |
Department of Neonatology, A-Block, 1st floor, ICH & HC, Egmore
Tamil Salai
Chennai
Department of Neonatology, A-Block, 1st floor, ICH & HC, Egmore
Tamil Salai
Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
9841102746 |
| Fax |
|
| Email |
drkamal.rathnam@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF.
Dr Mounika B, PG Student, Department of Neonatology, A-block, 1st floor, Institue of Child Health and Hospital for Children, Tamil Salai, Egmore, Chennai- 600008 |
|
|
Primary Sponsor
|
| Name |
DR MOUNIKA B |
| Address |
Department of Neonatology, 1s floor, A- Block, Institute of Child Health & Hospitalfor Children, Tamil Salai, Egmore, Chennai- 600008 |
| Type of Sponsor |
Other [SELF] |
|
|
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 MOUNIKA B |
Institute of Child Health and Hospital for Children |
Department of Neonatology, A-block, 1st floor, ICH and HC, Tamil Salai, Egmore-600008
Chennai
TAMIL NADU |
8123705285
mounabhaskarnaidu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MADRAS MEDICALCOLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Multisensory Stimulation
|
1. MSS:
- Before engaging in stimulations, the mother will be trained by the researcher on the correct methods of performing the interventions using videos and demonstrations over the mannequin.
- At first, the infant will be placed in a supine position with hands and legs bent as in fetal position.
- For tactile stimulation - the face, upper, and lower limbs of the infant will be gently touched by the other, performed from 20 minutes before the beginning of examination until the time of examination.
- For hearing stimulation - the mother will be asked to speak or sing a lullaby to her baby gently and continuously. This intervention will be performed from 20 minutes before the beginning of the examination until the time of the examination.
- For olfactory stimulation – 1 % Vanilla solution will be stained in a piece of sterile gauze and held close to the infant’s nose without any contact, at an average distance of 1 to 2 mm. This intervention will be performed from 20 minutes before the beginning of the examination until the time of the examination.
- For taste stimulation – o.5 ml/kg of EBM shall be drawn into a syringe by the researcher. The syringe mouth without a needle was placed into the infant’s mouth and the solution will be injected into the infant’s mouth with gentle movements along with the infant’s sucking for 30 seconds. This intervention will be started 2 minutes before the examination.
- For visual stimulation - the mother will be asked to look at her baby from nearby and try for eye communication to attract the infant’s attention. This intervention will be performed from 20 minutes before the beginning of the examination until the time of the examination. However, since the infant’s eyes will be dilated, the effect of this visual stimulation is unreliable.
|
| Intervention |
2. Oral Paracetamol |
A dose of 15 mg/kg will be administered orally 60 min before the procedure along with the standard care. |
| Comparator Agent |
Control |
Standard care of combination of topical anesthetic eye drops (0.5% proparacaine) 30 seconds before examination combined with swaddling of the infant.
A mydriatic combination of tropicamide 0.8% with Phenylephrine 0.5% 1 drop in each eye will be instilled every 10–15 min four times starting 1hr before the scheduled time for the examination. After instilling 1 drop of topical anesthetic, 0.5 % Proparacaine, a wire speculum will be inserted to keep the eyelids apart and an examination will be done by a senior ophthalmologist using the wide-angle digital retinal camera. All the procedures in this study will be done by the same trained ophthalmology technician and all neonates will receive standard care during the examination. Video recordings will be done using a tripod and camera capturing the baby and pulse-oximeter, starting from 1min before 1-hour post-procedure. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
1. Neonates who will be undergoing ROP screening as per ILROP-3 recommendation for the first time. |
|
| ExclusionCriteria |
| Details |
1. Infants with IVH 3 or more
2. Infants on a mechanical ventilator, inotropes, sedatives
3. Infants who underwent any surgery
4. Major congenital anomalies - cardiac, neurological, facial palsy
5. Those infants whose mothers will not be available during the intervention
6. Infants whose parents do not consent to participate in the trial
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the mean scores of pain severity of MSS and the Control group using the PIPP-R scale during the below 10 described stages.
2. To compare the mean scores of pain severity of oral Paracetamol and the Control group using the PIPP-R scale during the below 10 described stages.
2. To compare the mean scores of pain severity of oral Paracetamol and the Control group using the PIPP-R scale during the below 10 described stages.
|
- 30 seconds before examination
- During the examination of the 1st eye
- During the examination of the 2nd eye
- 30 seconds after the end of the examination
- 1 minute after the end of the examination
- 1.5 minutes after the end of the examination
- 2 minutes after the end of the examination
- 5 minutes after the end of the examination
- 30 minutes after the end of the examination
- 1 hour after the end of the examination
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the mean scores of pain severity between the MSS and oral Paracetamol groups using the PIPP-R scale during the 10 described stages |
- 30 seconds before examination
- During the examination of the 1st eye
- During the examination of the 2nd eye
- 30 seconds after the end of the examination
- 1 minute after the end of the examination
- 1.5 minutes after the end of the examination
- 2 minutes after the end of the examination
- 5 minutes after the end of the examination
- 30 minutes after the end of the examination
- 1 hour after the end of the examination
|
| 2. To compare the trend of mean scores of pain severity using the PIPP-R scale of all the three groups during the 10 described stages. |
- 30 seconds before examination
- During the examination of the 1st eye
- During the examination of the 2nd eye
- 30 seconds after the end of the examination
- 1 minute after the end of the examination
- 1.5 minutes after the end of the examination
- 2 minutes after the end of the examination
- 5 minutes after the end of the examination
- 30 minutes after the end of the examination
- 1 hour after the end of the examination
|
3. To compare the mean pain scores using the NIPS Pain Scale- Between MSS and control groups; Between oral paracetamol and control groups; Between MSS and oral paracetamol groups
|
- 6 hours post procedure
- 12 hours post procedure
- 24 hours post procedure
- 36 hours post procedure
- 48 hours post procedure
|
4. To compare the total cry time post-procedure- Between MSS and control groups; Between oral paracetamol and control groups; Between MSS and oral paracetamol group
|
Total cry time post-procedure |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
26/04/2024 |
| 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="0"
Months="6"
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mounabhaskarnaidu@gmail.com].
- For how long will this data be available start date provided 15-08-2025 and end date provided 14-08-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
ÂScreening for Retinopathy of prematurity (ROP) in preterm infants is one of the most painful procedures. Non-pharmacological methods like, expressed breast milk (EBM), non-nutritive sucking (NNS), facilitated tucking, and swaddling, and pharmacological methods like topical analgesia alone or with oral paracetamol, intranasal fentanyl, and morphine have been studied for analgesia for pain during ROP screening. Previous studies (only 4 studies) on oral paracetamol for pain during ROP screening, have shown varied results from significant to no effect. As per our literature search till now, there are very few (Only 2) studies on the effect of Multi-Sensory Stimulation (MSS) on pain during ROP screening. Also, we could not find any studies comparing the efficacy of the non-pharmacological modality of MSS versus oral Paracetamol for pain during ROP screening. Hence, this multi-arm trial aims to study the effect of MSS and oral Paracetamol against the control of Topical analgesia, which is a standard recommendation by various governing bodies, and also compare the efficacy of efficacy non-pharmacological modality of MSS versus oral Paracetamol for pain during ROP screening. |