| CTRI Number |
CTRI/2025/07/092071 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Expressed Mothers Own Milk] |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of analgesic effect of breast milk in preterm infants less than 34 weeks by meauring the premature infant pain profile revised score and comparing the scores between the two study groups. |
|
Scientific Title of Study
|
Analgesic effect of breast milk in preterm infants less than 34 weeks undergoing ROP screening _ A randomized control 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 Anupa Johny Ekka |
| Designation |
DM Resident |
| Affiliation |
Lokmanya tilak municipal medical college and general hospital |
| Address |
Department of Neonatology
Room no 123
First floor
Medical college building
Lokmanya tilak municipal medical college & general hospital
Sion
Mumbai
Department of Neonatology
Room no 123
First floor
Medical college building
Lokmanya tilak municipal medical college and general hospital
Sion
Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9507505906 |
| Fax |
|
| Email |
anupa13ekka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Mondkar |
| Designation |
Professor |
| Affiliation |
Lokmanya tilak municipal medical college and general hospital |
| Address |
Department of neonatology
Room NO 123
First floor
Medical college building Lokmanya tilak municipal Medical college and general Hospital
Sion
Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9920289755 |
| Fax |
|
| Email |
jayashreemondkar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupa Johny Ekka |
| Designation |
DM Resident |
| Affiliation |
Lokmanya tilak municipal medical college and general hospital |
| Address |
Department of Neonatology
Room no 123
First floor
Medical college building
Lokmanya tilak municipal medical college and general hospital
Sion
Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9507505906 |
| Fax |
|
| Email |
anupa13ekka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neonatology, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, Maharashtra 400022, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Anupa Johny Ekka |
Stepdown unit of a tertiary care neonatal center |
Department of Neonatology Lokmanya Tilak Municipal Medical College and General Hospital
Mumbai
MAHARASHTRA |
9507505906
anupa13ekka@gmail.com2 |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE HUMAN RESEARCH LTMMC & LTMGH |
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 |
| Intervention |
Nonpharmacological analgesic effect of mothers own milk |
Intervention group A will receive a sterile swab dipped in 3ml of expressed mothers own breast milk to suckle on throught the screening of ROP |
|
|
Inclusion Criteria
|
| Age From |
14.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
All infants less than 34 weeks gestation with birth weight less than 2000 grams (RBSK guidelines) |
|
| ExclusionCriteria |
| Details |
Infants on respiratory support
Infants who are hemodynamically unstable
Infants on drugs causing central nervous depression like sedatives,opioid analgesics or anticonvulsants
Infants who are nil by mouth
Infants with major/orofacial congenital malformations |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of PIPP-R scores between the two study groups |
Baseline,5 minutes prior to the procedure,immediately after the procedure and 5 minutes after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of cry time between the two study groups |
During the procedure & 5 minutes after the procedure |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
18/08/2025 |
| 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="0"
Months="6"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 project title is analgesic effect of breast milk in preterm infants less than 34 weeks undergoing ROP screening which will be an open label randomized control trial single center. The study will be non sponsored study and will be completing in the span of 6 months. |