| CTRI Number |
CTRI/2023/09/057787 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Use of expressed breast milk, facilitated tucking to relief pain in heel-stick in newborns] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study different pain relief modalities in preterm neonates during heel-stick |
|
Scientific Title of Study
|
A randomized controlled trial to compare the efficacy of expressed breast milk, facilitated tucking and combination of expressed breast milk and facilitated tucking in providing pain relief after heel-stick in preterm infants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupam Das |
| Designation |
DM, senior resident |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, second floor, Bharati Hospital, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
6000622460 |
| Fax |
|
| Email |
rd.rupam21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandini Malshe |
| Designation |
Associate Professor, Department of Neonatology, Bharati Vidyapeeth Deemed University Medical College |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, second floor, Bharati Hospital, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822850716 |
| Fax |
|
| Email |
malshenandini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupam Das |
| Designation |
DM, senior resident |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, second floor, Bharati Hospital, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
6000622460 |
| Fax |
|
| Email |
rd.rupam21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University Medical College, Pune |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, Bharati Hospital, Dhankawadi, Pune |
| 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 Rupam Das |
Bharati Hospital, Pune |
Department of Neonatology, Division of ICU, Room NICU
Pune
MAHARASHTRA |
6000622460
rd.rupam21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Expressed breast milk |
one arm with newborns will receive expressed breast milk, 0.5-2ml soaked in a gauze piece held into the infants mouth 2 minutes before heel-stick and continued till 4 minute after heel-stick. |
| Intervention |
Expressed breast milk with facilitated tucking |
one arm with newborns will receive facilitated tucking along with expressed breast milk 0.5-2ml soaked in a gauze piece held into the infants mouth 2 minutes before heel-stick and continued till 4 minute after heel-stick. |
| Intervention |
Facilitated tucking |
one arm with newborns will receive facilitated tucking(keeping infant in a flexed, midline position) before heel-stick and continued till 4 minute after heel-stick. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
All newborns from 27 to less than 37 weeks |
|
| ExclusionCriteria |
| Details |
1) preterm infants on invasive ventilation
2) major congenital malformation or known genetic abnormalities
3) preterm infants with encephalopathy
4)Preterm infants receiving sedatives
5) hemodynamically unstable preterm infants |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of expressed breast milk, facilitated tucking & combination of expressed breast milk & facilitated tucking in providing pain relief after heel-stick in preterm infants at the time of heel-stick using PIPP score (Premature Infant Pain Profile score) and compare the score before and after the heel-stick |
at time of heel-stick |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of expressed breast milk, facilitated tucking & combination of expressed breast milk & facilitated tucking in providing pain relief after heel-stick in preterm infants at 1 & 4 minutes using PIPP score (Premature Infant Pain Profile score) |
1 minute & 4 minutes |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
Final Enrollment numbers achieved (Total)= "168"
Final Enrollment numbers achieved (India)="168" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/09/2023 |
| Date of Study Completion (India) |
31/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/05/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Our study aims to compare the efficacy of
expressed breast milk and facilitated tucking in relieving preterm infants’
pain in heel-stick procedure.
So far no study has been done in India to compare the effects of expressed
breast milk with facilitated tucking either alone or in combination for preterm
infants’ pain relief during heel-sticking. Although, it has been suggested that
24% sucrose solution acts as an effective pain management strategy for preterm
infants before heel-stick procedure, it is not available
in the Indian market. Our alternative,
that is, expressed breast milk and facilitated tucking are inexpensive, quick,
easy to use and accessible in every settings, and therefore can be used as pain
relieving methods of treatment before heel-sticking. Also,the findings will help to provide the best method to relief newborn pain after heel-stick procedures |