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Breastmilk Alone or in Combination With Paracetamol for Reducing Pain

Efficacy of Expressed Breast Milk Alone or in Combination With Paracetamol in Reducing Pain During ROP Screening

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05354479
Enrollment
60
Registered
2022-04-29
Start date
2021-10-20
Completion date
2022-04-19
Last updated
2022-04-29

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

Conditions

Pain Control

Brief summary

Efficacy of Expressed Breast Milk Alone or in Combination with Paracetamol in Reducing Pain during ROP Screening.

Detailed description

Retinopathy of prematurity (ROP) has been widely acknowledged to be the primary cause of preventable childhood blindness in developing countries. However, the procedure for screening is extremely painful. In this study, we will attempt to relieve the pain experienced by these babies using breast milk alone or in combination with oral paracetamol. This randomized control trial study will be conducted with the aim to assess the efficacy of Expressed Breast Milk Alone or in Combination with Paracetamol in Reducing Pain during ROP Screening. All preterm neonate who undergone ROP screening will be the study population. A total of 60 preterm neonates will be randomized into three groups: (Group A - control group = 20, Group B - breast milk group = 20, and Group C - oral paracetamol + breast milk = 20). Group A will get current care as per institutional protocol, Group B received 2 ml expressed breast milk (EBM) through a sterile syringe orally 2 min prior to procedure, Group C received syrup paracetamol, 15 mg/kg 30 min prior to procedure and EBM as in Group B. Pain experienced was measured by the premature infant pain profile (PIPP) score 20 s prior, during and 2 min after procedure. All procedures were video recorded. The Ophthalmologist and analyzer both will be blinded to the intervention. Results will be incorporated after enrollment

Interventions

DRUGParacetamol

babies will get expressed breast milk along with paracatamol for pain relief

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Both investigator and outcome assessor will be blinded.

Intervention model description

Double blinded Randomized control trial

Eligibility

Sex/Gender
ALL
Age
20 Days to 2 Months
Healthy volunteers
No

Inclusion criteria

* 1\. Gestational age \<35 weeks, and birth weight \<2000 gm

Exclusion criteria

* 1\. Parents of neonate who refused to participate in the study 2. Newborns with multiple congenital anomalies 3. Patient who is on mechanical ventilator during ROP examination 4. Neonate receiving narcotic or sedative drugs 5. Neonate not receiving oral feed.

Design outcomes

Primary

MeasureTime frameDescription
Decrease in pain6 monthsPremature Infant Pain Score

Countries

Bangladesh

Contacts

Primary ContactRumpa Mani Chowdhury, FCPS,MD
rumpamonichowdhury@gmail.com+8801816356807

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026