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

Primary Purpose

Diaper Rash, Preterm Neonates

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Colloidal oatmeal
Cold cream
Sponsored by
Seham El-Sayed Saleh Hassan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diaper Rash focused on measuring Colloidal oatmeal, Diaper rash, Preterm neonates

Eligibility Criteria

34 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Matrouh university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Colloid group

Colloid oatmeal group

Arm Description

The control group received the usual care of the unit.

Received cold cream three times a day on the rash area while diaper changing by the researcher plus the usual care

Received colloid oatmeal cream three times a day on the rash area while diaper changing by the researcher plus the usual care

Outcomes

Primary Outcome Measures

Preterm neonates who receive colloid assessed by rash scale score.
Mild degree of diaper rash score will mean improvement in diaper rash

Secondary Outcome Measures

Full Information

First Posted
April 11, 2023
Last Updated
September 20, 2023
Sponsor
Seham El-Sayed Saleh Hassan
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1. Study Identification

Unique Protocol Identification Number
NCT05892081
Brief Title
Colloidal Oatmeal, Colloid Cream, Diaper Rash, Preterm Neonates and Neonatal Intensive Care Unit
Official Title
Effect of Colloidal Oatmeal Compared to Colloid Cream on Diaper Rash Among Preterm Neonates in the Neonatal Intensive Care Unit.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
January 12, 2022 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seham El-Sayed Saleh Hassan

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaper Rash, Preterm Neonates
Keywords
Colloidal oatmeal, Diaper rash, Preterm neonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group received the usual care of the unit.
Arm Title
Colloid group
Arm Type
Experimental
Arm Description
Received cold cream three times a day on the rash area while diaper changing by the researcher plus the usual care
Arm Title
Colloid oatmeal group
Arm Type
Experimental
Arm Description
Received colloid oatmeal cream three times a day on the rash area while diaper changing by the researcher plus the usual care
Intervention Type
Biological
Intervention Name(s)
Colloidal oatmeal
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Cold cream
Intervention Description
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
Primary Outcome Measure Information:
Title
Preterm neonates who receive colloid assessed by rash scale score.
Description
Mild degree of diaper rash score will mean improvement in diaper rash
Time Frame
four days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Matrouh university
City
Mersa Matruh
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Colloidal Oatmeal, Colloid Cream, Diaper Rash, Preterm Neonates and Neonatal Intensive Care Unit

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