| CTRI Number |
CTRI/2025/02/081362 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of intensity of pain during examinations of preterm newborns undergoing retinopathy of prematurity screening between Reverse-Kangaroo Mother Care and conventional positioning on cradle. |
|
Scientific Title of Study
|
Effectiveness of the Reverse-Kangaroo Mother Care position as a non-pharmacological method for reducing pain during retinopathy of prematurity screening in pre-term newborns in comparison to conventional position: A comparative study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhruv Kumar |
| Designation |
MBBS Undergraduate Student |
| Affiliation |
Maharaja Agrasen Medical College |
| Address |
Room No.91
Department of paediatrics,
A- Block
Maharaja Agrasen Medical College
Agroha
Hisar
Room No.91
Department of paediatrics,
A- Block
Maharaja Agrasen Medical College
Agroha
Hisar
Hisar
HARYANA
125047
India |
| Phone |
7836810090 |
| Fax |
|
| Email |
dkg11dhruvgupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Kumar |
| Designation |
Associate Professor |
| Affiliation |
Maharaja Agrasen Medical College |
| Address |
Room Number 90
Paediatrics OPD
Maharaja Agrasen Medical College
Agroha
Hisar
Maharaja Agrasen Medical College
Agroha
Hisar
Hisar
HARYANA
125047
India |
| Phone |
7014197954 |
| Fax |
|
| Email |
drsgodara2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhruv Kumar |
| Designation |
MBBS Undergraduate Student |
| Affiliation |
Maharaja Agrasen Medical College |
| Address |
Room No.91
Department of paediatrics,
A- Block
Maharaja Agrasen Medical College
Agroha
Hisar
Room No.91
Department of paediatrics,
A- Block
Maharaja Agrasen Medical College
Agroha
Hisar
Hisar
HARYANA
125047
India |
| Phone |
7836810090 |
| Fax |
|
| Email |
dkg11dhruvgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Resources of Maharaja Agrasen Medical College ,Agroha will be used
Maharaja Agrasen Medical College Agroha
Hisar-125047
India |
|
|
Primary Sponsor
|
| Name |
Maharaja Agrasen Medical College Agroha |
| Address |
Maharaja Agrasen Medical College Agroha
Hisar- 125047
India |
| Type of Sponsor |
Private 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 Surendra Kumar |
Maharaja Agrasen Medical College |
Room No.91
Department of paediatrics,
A- Block
Hisar
HARYANA |
7014197954
drsgodara2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research Maharaja Agrasen Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H351||Retinopathy of prematurity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Method of Screening for Retinopathy of Prematurity Screening for pre term newborns |
Control Group will be given Conventional care Treatment with infant lying down on a bed/couch. The total intervention time is 5-10mins. |
| Intervention |
Reverse Kangaroo Mother Care Procedure |
Reverse Kangaroo Mother Care (R-KMC) is an innovative adaptation of the traditional Kangaroo Mother Care (KMC) method, specifically designed to enhance the care of premature infants. In R-KMC, the infant’s position is reversed so that the baby’s face is oriented differently in relation to the mother’s chest. This adjustment aims to maintain the comforting and stabilizing effects of KMC while allowing better access for medical procedures. The total intervention time is 5-10 mins. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All the pre term infants undergoing Retinopathy of Prematurity (ROP) Screening Examination whose parents have given consent for the study. |
|
| ExclusionCriteria |
| Details |
Pre-Term Infants will be excluded from the study if they need any respiratory support, inotropic support or are born with significant congenital disabilities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Premature Infant Pain Profile during Retinopathy of Prematurity screening in pre-term newborns in the Reverse-Kangaroo Mother Care position. |
Baseline Just 1 minute before and 1 minute After the Procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The physiological Parameters such as heart rate, respiratory rate & crying during Retinopathy of Prematurity screening in pre-term newborns in the Reverse-Kangaroo Mother Care (R-KMC) position. |
Baseline 1 minute Before & 1 minute after the Procedure |
|
|
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)
|
17/03/2025 |
| 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="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 - NO
|
|
Brief Summary
|
The Study Design will be a double-arm, parallel-group, open-label, randomized controlled trial hence comparing the Premature Infant Pain Profile during Retinopathy of Prematurity screening in pre-term newborns in the Reverse-Kangaroo Mother Care (R-KMC) Position to the conventional position in reducing pain. It will also compare the physiological Parameters such as heart rate, respiratory rate and crying in this position to the conventional position in reducing pain.
It is a Hospital-based study to be conducted in NICU (Neonatal Intensive Care Unit) of Tertiary Care Teaching Institute (Maharaja Agrasen Medical College, Agroha).
The objectives are as follows: Primary Objective: To compare the Premature Infant Pain Profile during Retinopathy of Prematurity screening in pre-term newborns in the Reverse-Kangaroo Mother Care (R-KMC) position to the conventional position in reducing pain.
Secondary Objective: To compare the physiological Parameters such as heart rate, respiratory rate and crying during Retinopathy of Prematurity screening in pre-term newborns in the Reverse-Kangaroo Mother Care (R-KMC) position to the conventional position in reducing pain.
The study will be conducted in 6 months duration. |