Colloidal Oatmeal, Colloid Cream, Diaper Rash, Preterm Neonates and Neonatal Intensive Care Unit

September 20, 2023 updated by: Seham El-Sayed Saleh Hassan

Effect of Colloidal Oatmeal Compared to Colloid Cream on Diaper Rash Among Preterm Neonates in the Neonatal Intensive Care Unit.

-This study aimed to investigate the effect of colloid oatmeal compared to colloid cream on diaper rash among preterm neonates in the NICU.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A quasi-experimental study was carried out in the NICU of El-Raml Children's Hospital at Wengat in Alexandria. Ninety preterm neonates were randomly assigned to three equal groups. The control group received the usual care of NICU for diaper rash, colloidal oatmeal group received colloidal oatmeal cream and colloid group received colloid cream (cold which is the base for colloid oatmeal)

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mersa Matruh, Egypt
        • Matrouh University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preterm neonates
  • Have diaper rash,
  • Hemodynamically stable
  • Receive enteral feeding (breast, bottle, gavage, or mixed feeding)
  • Newly admitted to the previously mentioned setting
  • On the first day of exposure to diaper rash

Exclusion Criteria:

  • Preterm who have candida infection in groin
  • Use other drugs for diaper rash

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group received the usual care of the unit.
Experimental: Colloid group
Received cold cream three times a day on the rash area while diaper changing by the researcher plus the usual care
Biological: Cold cream
It is composed of stearic acid 5, cretoctryl alcohol 2.5, cetyl alcohol 2.5, koh 02, potassium sorbate 1gm, paraffin oil 5ml, and soft paraffin 10gm
Experimental: Colloid oatmeal group
Received colloid oatmeal cream three times a day on the rash area while diaper changing by the researcher plus the usual care
Biological: Colloidal oatmeal
The colloid oatmeal had the following component: Colloidal Oat (5gm), stearic acid 5, cretoctryl alcohol 2.5, cetyl alcohol 2.5, koh 02, potassium sorbate 1gm, paraffin oil 5ml, and soft paraffin 10gm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm neonates who receive colloid assessed by rash scale score.
Time Frame: four days
Mild degree of diaper rash score will mean improvement in diaper rash
four days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seham El-Sayed Saleh Hassan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2021

Primary Completion (Actual)

January 12, 2022

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Document attached-Not given

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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