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Breastmilk Alone or in Combination With Paracetamol for Reducing Pain

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)
Overall Status
Recruiting
CT.gov ID
NCT05354479
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
5.9
Anticipated Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blinded Randomized control trialDouble blinded Randomized control trial
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Both investigator and outcome assessor will be blinded.
Primary Purpose:
Supportive Care
Official Title:
Efficacy of Expressed Breast Milk Alone or in Combination With Paracetamol in Reducing Pain During ROP Screening
Actual Study Start Date :
Oct 20, 2021
Anticipated Primary Completion Date :
Apr 19, 2022
Anticipated Study Completion Date :
Apr 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Expressed breast milk

Babies will get only expressed breast milk.

Drug: Paracetamol
babies will get expressed breast milk along with paracatamol for pain relief
Other Names:
  • Breast milk

    		•
    Experimental: paracetamol plus expressed breast milk

    Babies will get expressed breast milk plus paracetamol

    Drug: Paracetamol
    babies will get expressed breast milk along with paracatamol for pain relief
    Other Names:
  • Breast milk

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Decrease in pain [6 months]

      Premature Infant Pain Score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Days to 2 Months
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BSMMu Dhaka Bangladesh

    Sponsors and Collaborators

    • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rumpa Mani Chowdhury, DR, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
    ClinicalTrials.gov Identifier:
    NCT05354479
    Other Study ID Numbers:
    • 585
    First Posted:
    Apr 29, 2022
    Last Update Posted:
    Apr 29, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Acetaminophen

    Study Results

    No Results Posted as of Apr 29, 2022