NCT05354479

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

April 26, 2022

Last Update Submit

April 28, 2022

Conditions

Pain Control

Outcome Measures

Primary Outcomes (1)

  • Decrease in pain

    Premature Infant Pain Score

    6 months

Study Arms (2)

Expressed breast milk

ACTIVE COMPARATOR

Babies will get only expressed breast milk.

Drug: Paracetamol

paracetamol plus expressed breast milk

EXPERIMENTAL

Babies will get expressed breast milk plus paracetamol

Drug: Paracetamol

Interventions

ParacetamolDRUG

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

Also known as: Breast milk
Expressed breast milkparacetamol plus expressed breast milk

Eligibility Criteria

Age20 Days - 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BSMMu

Dhaka, Bangladesh

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

AcetaminophenMilk, Human

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Central Study Contacts

Rumpa Mani Chowdhury, FCPS,MD

CONTACT

+8801816356807rumpamonichowdhury@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Both investigator and outcome assessor will be blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Double blinded Randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

April 26, 2022

First Posted

April 29, 2022

Study Start

October 20, 2021

Primary Completion

April 19, 2022

Study Completion

April 19, 2022

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations

BA(1)