| CTRI Number |
CTRI/2025/08/092503 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to find ability of reverse kangaroo care in decreasing pain in babies undergoing eye test to check the condition ROP |
|
Scientific Title of Study
|
Effectiveness of reverse kangaroo mother care (rKMC) in reducing pain in neonates during retinopathy of prematurity (ROP) screening- An open labelled 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 |
Dr Vijaykumar |
| Designation |
Junior resident |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Pediatrics, AIIMS Bathinda, Jodhpur romana, Mandi Dabwali road, Bathinda, Punjab - 151001
Bathinda
PUNJAB
151001
India |
| Phone |
9916791402 |
| Fax |
|
| Email |
vijaymedha222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manish Swami |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Neonatology, AIIMS Bathinda, Jodhpur romana, Mandi Dabwali road, Bathinda, Punjab - 151001
Bathinda
PUNJAB
151001
India |
| Phone |
9991909318 |
| Fax |
|
| Email |
dmanishswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaykumar |
| Designation |
Junior resident |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Pediatrics, AIIMS Bathinda, Jodhpur romana, Mandi Dabwali road, Bathinda, Punjab - 151001
Bathinda
PUNJAB
151001
India |
| Phone |
9916791402 |
| Fax |
|
| Email |
vijaymedha222@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics, AIIMS Bathinda, Jodhpur romana, Mandi Dabwali road, Bathinda, Punjab - 151001, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Bathinda |
| Address |
Jodhpur romana, Mandi Dabwali road, Bathinda, Punjab - 151001 |
| 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 Vijaykumar |
AIIMS Bathinda |
Department of Neonatology, Jodhpur romana, Mandi Dabwali road, Bathinda, Punjab - 151001
Bathinda
PUNJAB |
9916791402
vijaymedha222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ROP screening in conventional method |
The neonate is screened for ROP on radiant warmer |
| Intervention |
ROP screening in rKMC position |
The neonate is screened for ROP while on reverse kangaroo mother care (rKMC) position till its completion usually 2-10minutes |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Day(s) |
| Gender |
Both |
| Details |
1. Neonates who require ROP screening under GOI (RBSK 2017) guidelines.
2. Neonates either on room air or non-invasive respiratory support requiring FiO2 less than/equal to 30% at the time of ROP screening.
3. Neonates with weight more than 800 grams at the time of ROP screening regardless of mode of delivery, gestational age, singleton or twin status. |
|
| ExclusionCriteria |
|
|
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 |
To determine the
effectiveness of reverse
KMC in reducing the pain
during ROP screening |
Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare difference in PIPP-R score |
Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum) |
Determine & compare mean change in
Heart rate (HR), SpO2, Respiratory rate
(RR) before & after procedure in
rKMC vs Conventional arm |
Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum) |
| Compare number of apnea episodes in rKMC vs Conventional arm |
Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum) |
| Procedural time difference between both the arms |
From insertion of speculum
and removal of speculum |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
19/08/2025 |
| 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)
|
Open to Recruitment |
| 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
|
This study examines reverse Kangaroo Mother Care (rKMC) as an innovative approach to improve ROP screening in preterm neonates by reducing pain, enhancing comfort, and addressing challenges in traditional methods. |