Breast milk vs 25% Dextrose for pain reduction during ROP examination

A comparison of breastmilk and 25% dextrose in reduction of neonatal pain during retinopathy of prematurity (ROP) examination: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/031753

Enrollment

Registered

2021-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: H36- Retinal disorders in diseases classified elsewhere

Interventions

Intervention1: breast milk: Breast milk (intervention) and 25% Dextrose (comparator) will be used as study drugs. Study drug 1ml/kg is administered into buccal cavity 2minutes prior and 1ml/kg during

Eligibility

Inclusion criteria

Inclusion criteria: Inborn neonates ( <34 weeks gestational age and/or <1750grams at birth) undergoing ROP examination

Exclusion criteria

Exclusion criteria: 1) Congenital anomalies 2) Hydrocephalus 3) Necrotizing enterocolitis 4) Nil by mouth 5) On analgesic drug treatment 6) On ventilatory support 7) Underwent surgeries

Design outcomes

Primary

Measure	Time frame
To compare the mean PIPP scores of neonates receiving breastmilk vs 25%D during ROP examinationTimepoint: baseline( i.e., during the procedure)	—

Secondary

Measure	Time frame
The mean PIPP scores before and after ROP examinationTimepoint: 5minutes before, 2 minutes and 5 minutes after ROP examination procedure;Time taken to reach the baseline pain scoreTimepoint: at least 10 minutes after the procedure	—

Countries

India

Contacts

Public ContactNivedita Mondal

JIPMER

nive.m8@gmail.com8098912969

Outcome results

None listed

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