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Breastmilk Alone or in Combination With Paracetamol for Reducing Pain

NCT ID: NCT05354479

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2022-04-19

Brief Summary

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

Detailed Description

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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

Conditions

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Pain Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded Randomized control trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Both investigator and outcome assessor will be blinded.

Study Groups

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Expressed breast milk

Babies will get only expressed breast milk.

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

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

paracetamol plus expressed breast milk

Babies will get expressed breast milk plus paracetamol

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

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

Interventions

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Paracetamol

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

Intervention Type DRUG

Other Intervention Names

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Breast milk

Eligibility Criteria

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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.
Minimum Eligible Age

20 Days

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Rumpa Mani Chowdhury

DR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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BSMMu

Dhaka, , Bangladesh

Site Status RECRUITING

Countries

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Bangladesh

Central Contacts

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Rumpa Mani Chowdhury, FCPS,MD

Role: CONTACT

Phone: +8801816356807

Email: [email protected]

Facility Contacts

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Rumpa Mani Chowdhury, FCPS,MD

Role: primary

Other Identifiers

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585

Identifier Type: -

Identifier Source: org_study_id