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Administration of mothers milk and sweet solution to relieve newborn pain during BCG injection

A randomized controlled trial to assess the effectiveness of 25% dextrose verses direct breast feed milk in the management of neonatal pain in a selected hospital in new delhi

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038491
Enrollment
130
Registered
2021-12-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Not applicable: Nil Intervention2: 25% dextrose: .6 ml/kg of body weight neonates administered 2 minutes prior to BCG vaccination, - neonates pain with NIPS Score, during, 2 minute

Sponsors

A Malar selvi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates who are born in selected hospitals like Safdurjung Hospital. 2.Term neonates with gestation age of 37 to 40 weeks 3. Neonates who are undergoing BCG vaccination 4. Neonates whose mothers are willing to study 5. Mothers who are stable

Exclusion criteria

Exclusion criteria: 1. Mothers who are not producing enough milk 2. Neonates having sepsis, birth asphyxia, neurological deficits, congenital anomalies 3. Term neonates receiving analgesics, sedatives, and muscle relaxants. 4. Term neonates whose mothers are not willing to be part of the study.

Design outcomes

Primary

MeasureTime frame
Pain score during,2 minutes, 5 minutes of post vaccinationTimepoint: before intervention, during, at 2 minutes, at 5 minutes.

Secondary

MeasureTime frame
Duration of cry, oxygen saturation, heart rate before, during, at 2 minutes, at 5 minutes of post interventionTimepoint: before, during, at 2 minutes, at 5 minutes

Countries

India

Contacts

Public ContactA Malar selvi

Amity College of Nursing, Amity University

agauba@ggn.amity.edu9810245092

Outcome results

None listed

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