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Evaluation of analgesic effect of breast milk in preterm infants less than 34 weeks by meauring the premature infant pain profile revised score and comparing the scores between the two study groups.

Analgesic effect of breast milk in preterm infants less than 34 weeks undergoing ROP screening _ A randomized control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/092071
Enrollment
70
Registered
2025-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: H351- Retinopathy of prematurity

Interventions

Intervention1: Nonpharmacological analgesic effect of mothers own milk: Intervention group A will receive a sterile swab dipped in 3ml of expressed mothers own breast milk to suckle on throught the sc

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All infants less than 34 weeks gestation with birth weight less than 2000 grams (RBSK guidelines)

Exclusion criteria

Exclusion criteria: Infants on respiratory support Infants who are hemodynamically unstable Infants on drugs causing central nervous depression like sedatives,opioid analgesics or anticonvulsants Infants who are nil by mouth Infants with major/orofacial congenital malformations

Design outcomes

Primary

MeasureTime frame
Comparison of PIPP-R scores between the two study groupsTimepoint: Baseline,5 minutes prior to the procedure,immediately after the procedure and 5 minutes after the procedure—

Secondary

MeasureTime frame
Comparison of cry time between the two study groupsTimepoint: During the procedure & 5 minutes after the procedure—

Countries

India

Contacts

Public ContactDr Anupa Johny Ekka

Lokmanya tilak municipal medical college and general hospital

jayashreemondkar@rediffmail.com9920289755

Outcome results

None listed

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