Home » Trials » SLCTR/2019/027

A non-randomized controlled before and after study to determine the effectiveness of an Illustrated Information Leaflet (IIL) on maternal practice of administering paediatric antibacterial suspensions


SLCTR Registration Number


Date of Registration

07 Aug 2019

The date of last modification

Oct 14, 2019

Application Summary

Scientific Title of Trial

A non-randomized controlled before and after study to determine the effectiveness of an Illustrated Information Leaflet (IIL) on maternal practice of administering paediatric antibacterial suspensions

Public Title of Trial

A non randomized controlled trial to determine the effectiveness of an illustrated information leaflet on teacher mothers’ practices on administering paediatric antibacterial suspensions

Disease or Health Condition(s) Studied

Administration of antibacterial suspension

Scientific Acronym


Public Acronym


Brief title

An intervention to improve the administering practices of antibacterial suspension by mothers

Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

EC-18-006 ,ERC ,Faculty of Medicine ,UOC

Trial Details

What is the research question being addressed?

Can an illustrated information leaflet reduce the errors made by teacher mothers when administering paediatric antibacterial suspensions?

Type of study


Study design


Non-randomized controlled trial


Single blinded : Investigators


Standard therapy/practice





Study Phase

Not Applicable

Intervention(s) planned

An initial descriptive study was done on teacher mothers to determine the prevalence of proper and improper practice when administering paediatric antibacteric suspensions using a scorecard. For the intervention study participants from different education zones in the Jaffna district will be selected. A block randomization procedure will be done to have the proportion of correct practice: incorrect practice teachers across the two arms. The final illustrated information leaflet (IIL) was translated into Tamil and was pretested This IIL conveys information on reconstitution techniques, measuring devices, and administration and storing instructions. The leaflet will be given by principal investigator just before collecting the data. Time will be given to read and understand the leaflet. Any queries will be clarified before collecting data

Inclusion criteria

1.Female teachers below 60 years 2. Have at least one child under the age of 6

Exclusion criteria

  1. Teacher whose family members are health care professionals (doctor/nurse /pharmacist)
  2. Whose children have long term illness and visit the hospital at least once a week 3.Who have previous work experience as a health care professional or social worker 4.Who has participated in any study related to oral liquid dosage forms administration previously

Primary outcome(s)


1.Proportion of mothers with administration errors when administering oral antibacterial suspension. This will be assessed using a scorecard which was developed by the experts during the descriptive study. There are 21 steps each carrying either 1 or 0 marks


Soon after the intervention and 3 months after the intervention


Secondary outcome(s)


1.Acceptability of the intervention by the participants using a questionnaire.

8 questions will be marked by the mothers on a Liket scale of 1-5 If all the questions get overall panel median score of > 3 it is considered as acceptable.


After 3 months of the intervention


Target number/sample size

20 in each arm

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment


Date of study completion

Recruitment status


Funding source

self funded

Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: Ethics Review committee,Faculty of Medicine,University of Colombo
Institutional Address:No. 25, Kynsey Road, Colombo 00800, Sri Lanka
Telephone:+94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Abarna Nadeshkumar
Department of Pharmacy and Pharmaceutical Sciences Faculty of Allied Health Sciences University of Sri Jayewardenepura Nugegoda



Contact Person for Public Queries

Professor Shalini Sri Ranganathan
Department of Pharmacology Faculty of Medicine University of Colombo
+94 (0) 112695300 ext 198


Primary study sponsor/organization

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Study protocol available


Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results