To study different pain relief modalities in preterm neonates during heel-stick

Phase 4

Completed

• Conditions: Other problems with newborn,

• Registration Number: CTRI/2023/09/057787
• Lead Sponsor: Bharati Vidyapeeth Deemed University Medical College, Pune

Brief Summary

Our study aims to compare the efficacy ofexpressed 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 expressedbreast milk with facilitated tucking either alone or in combination for preterminfants’ pain relief during heel-sticking. Although, it has been suggested that24% sucrose solution acts as an effective pain management strategy for preterminfants before heel-stick procedure, it is not availablein  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 painrelieving methods of treatment before heel-sticking. Also,the findings will help to provide the best method to relief newborn pain after heel-stick procedures

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-28
• Study Completion: 2024-05-31
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

All newborns from 27 to less than 37 weeks.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bharati Hospital, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Bharati Hospital, Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Rupam Das

Principal investigator

6000622460

rd.rupam21@gmail.com