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Effect of expressed breast milk for pain relief during blood sampling in newborns

Effect of Expressed Breast Milk for pain relief during venepuncture in Neonates: Open Labelled Randomised Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052982
Enrollment
70
Registered
2023-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

None listed

Interventions

Intervention1: STUDY THE ANALGESIC EFFECT OF ORALLY ADMINISTERED BREAST MILK VERSUS 10% DEXTROSE FOR PAIN RELIEF: PIPP-R SCORING WILL BE DONE DURING VENEPUNCTURE 0-30 SEC, AT 1-1.5 MINS AND AFTER 5-5.

Sponsors

DR TOYAJ SHUKLA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ALL HEMODYNAMICALLY STABLE FULL TERM NEONATES UPTO 1 WEEK POSTNATAL AGE ON BREASTFEED, REQUIRING VENEPUNCTURE FOR COMMON MORBIDITIES SUCH AS HYPERBILIRUBINEMIA AND NEWBORN SCREENING.

Exclusion criteria

Exclusion criteria: NEONATES WITH BIRTH ASPHYXIA ,CONGENITAL MALFORMATIONS,FEEDING INTOLERANCE,ANTIEPILEPTICS GIVEN WITHIN 12 HOURS,ANY DOCUMENTED EPISODES OF HYPOGLYCEMIA DURING HOSPITAL STAY,CLINICAL SIGNS OF KERNICTERUS/ENCEPHALOPATHY.

Design outcomes

Primary

MeasureTime frame
PROPORTION OF NEONATES EXHIBITING MILD TO MODERATE PAIN ACCORDING TO THE PIPP-R SCALE WITH EXPRESSED BREAST MILK IN COMPARISON TO 1O PERCENT DEXTROSE AFTER VENEPUNCTURE.Timepoint: 5.5 MINUTES—

Secondary

MeasureTime frame
ASSESS THE DURATION OF CRY TIME IN NEONATES OF BOTH GROUP AFTER VENEPUNCTURETimepoint: 5.5 MINUTES—

Countries

India

Contacts

Public ContactDR TOYAJ SHUKLA

YASHODA SUPERSPECIALITY HOSPITAL

ashprakash@yahoo.com9810157064

Outcome results

None listed

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