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

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057787

Enrollment

168

Registered

2023-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Expressed breast milk: one arm with newborns will receive expressed breast milk, 0.5-2ml soaked in a gauze piece held into infants mouth 2 minutes before heel-stick and continued till 4

Eligibility

Inclusion criteria

Inclusion criteria: All newborns from 27 to less than 37 weeks

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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-stickTimepoint: at time of heel-stick	—

Secondary

Measure	Time frame
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)Timepoint: 1 minute & 4 minutes	—

Countries

India

Contacts

Public ContactRupam Das

Bharati Vidyapeeth Deemed University Medical College, Pune

malshenandini@gmail.com9822850716

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026