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Completed

NCT Number: NCT05892081

Colloidal Oatmeal, Colloid Cream, Diaper Rash, Preterm Neonates and 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.

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Key information

Conditions

Diaper Rash Dermatitis Dermatitis, Contact Dermatitis, Irritant Preterm Neonates Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

34 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Matrouh university

Marsá Maţrūḩ, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colloidal oatmeal

Biological

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

Cold cream

Biological

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Seham El-Sayed Saleh Hassan

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 7, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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