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

Diaper Rash Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05892081
• Other study ID #: Document attached-Not given
• Status: Completed
• Phase: Phase 4
• Start date: August 20, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2023
• Source: Matrouh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 30, 2023
• Est. primary completion date: January 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 34 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Diaper Rash
• Premature Birth
• Preterm Neonates

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Matrouh university	Mersa Matruh

Sponsors (1)

Lead Sponsor	Collaborator
Seham El-Sayed Saleh Hassan

Country where clinical trial is conducted

Egypt, 

References & Publications (24)

Altmann T, Fischman. (2018). The dreaded diaper rash: A pediatrician's advice for preventing and treating an angry bottom. The dreaded diaper rash: A pediatrician's advice for preventing and treating an angry bottom - The Washington Post.

American Academy of Pediatrics. (2014). Diaper rash. Available from: http//www.pdf secret.com _diaper-rash-southwest-childrens-center.pdf.

Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN). Neonatal skin care evidence-based clinical practice guideline (3rd ed.). Washington, DC; (2013).

Baudouin C, Lachmann N, Rocheteau J, Chadoutaud B, Boy E, Leclere-Bienfait S. Diaper dermatitis management: a global and innovative strategy for a new generation of skin care. J Am Acad Dermatol, 2015; 72(5):199.

Blume-Peytavi U, Hauser M, Lunnemann L, Stamatas GN, Kottner J, Garcia Bartels N. Prevention of diaper dermatitis in infants--a literature review. Pediatr Dermatol. 2014 Jul-Aug;31(4):413-29. doi: 10.1111/pde.12348. Epub 2014 May 29. — View Citation

Blume-Peytavi U, Lavender T, Jenerowicz D, Ryumina I, Stalder JF, Torrelo A, Cork MJ. Recommendations from a European Roundtable Meeting on Best Practice Healthy Infant Skin Care. Pediatr Dermatol. 2016 May;33(3):311-21. doi: 10.1111/pde.12819. Epub 2016 Feb 26. — View Citation

Boyles, M. (2022).Health Benefits of Oatmeal and Oats. Available from: http//.www.Health Benefits of Oatmeal & Oats | Oatmeal to Soothe Itchy Skin | The Old Farmer's Almanac.

Buckley BS, Mantaring JB, Dofitas RB, Lapitan MC, Monteagudo A. A New Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants: Development and Validation. Pediatr Dermatol. 2016 Nov;33(6):632-639. doi: 10.1111/pde.12988. Epub 2016 Sep 22. — View Citation

Burdall O, Willgress L, Goad N. Neonatal skin care: Developments in care to maintain neonatal barrier function and prevention of diaper dermatitis. Pediatr Dermatol. 2019 Jan;36(1):31-35. doi: 10.1111/pde.13714. Epub 2018 Dec 2. — View Citation

Chat, S., Uppal, S., Kearns, D., Ashin, J. Colloidal Oatmeal in the Treatment of Atopic Dermatitis Is this plant-based intervention an effective treatment alternative? By Practical Dermatology. 2020.

Collier M, Simon D. Protecting vulnerable skin from moisture-associated skin damage. Br J Nurs. 2016 Nov 10;25(20 Suppl):S26-S32. doi: 10.12968/bjon.2016.25.20.S26. — View Citation

Furber C, Bedwell C, Campbell M, Cork M, Jones C, Rowland L, Lavender T. The challenges and realties of diaper area cleansing for parents. J Obstet Gynecol Neonatal Nurs. 2012 Nov-Dec;41(6):E13-25. doi: 10.1111/j.1552-6909.2012.01390.x. Epub 2012 Jul 23. — View Citation

Gregorio J, and Rodriguez K. Diaper Dermatitis in Infant Skin: Causes and Mitigation. neonatal INTENSIVE CARE. 2017; 30 (3):38-40.

Hugill K. Revisiting infant nappy dermatitis: causes and preventive care. Br J Midwifery, 2017;25(3):150-54.

Ilnytska O, Kaur S, Chon S, Reynertson KA, Nebus J, Garay M, Mahmood K, Southall MD. Colloidal Oatmeal <em>(Avena Sativa)</em> Improves Skin Barrier Through Multi-Therapy Activity. J Drugs Dermatol. 2016 Jun 1;15(6):684-90. — View Citation

Klunk C, Domingues E, Wiss K. An update on diaper dermatitis. Clin Dermatol. 2014 Jul-Aug;32(4):477-87. doi: 10.1016/j.clindermatol.2014.02.003. Epub 2014 Feb 28. — View Citation

Madhu R, Vijayabhaskar C, Anandan V, Nedunchelian K, Thangavelu S, Soans ST, Shastri DD, Parekh BJ, Kumar RR, Basavaraja GV. Indian Academy of Pediatrics Guidelines for Pediatric Skin Care. Indian Pediatr. 2021 Feb 15;58(2):153-161. — View Citation

Merrill L. Prevention, Treatment and Parent Education for Diaper Dermatitis. Nurs Womens Health. 2015 Aug-Sep;19(4):324-36; quiz 337. doi: 10.1111/1751-486X.12218. — View Citation

Morris H. The bottom line on nappy rash. Br J Midwifery, 2012; 20 (9):623-26.

Narayanan V, Ganjoo A, Kadhe G. Efficacy and Tolerability of an Oatmeal Moisturizer Containing Colloidal Oatmeal for Dry Skin Conditions: A Post-marketing Study. Indian Journal of Clinical Practice. 2016; 27(1): 1118-23.

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Panahi Y, Sharif MR, Sharif A, Beiraghdar F, Zahiri Z, Amirchoopani G, Marzony ET, Sahebkar A. A randomized comparative trial on the therapeutic efficacy of topical aloe vera and Calendula officinalis on diaper dermatitis in children. ScientificWorldJournal. 2012;2012:810234. doi: 10.1100/2012/810234. Epub 2012 Apr 19. — View Citation

Pazyar N, Yaghoobi R, Kazerouni A, Feily A. Oatmeal in dermatology: a brief review. Indian J Dermatol Venereol Leprol. 2012 Mar-Apr;78(2):142-5. doi: 10.4103/0378-6323.93629. — View Citation

Sarin, A., Bhatia, J., Sarkar, R.. Diaper Dermatitis. Asian Journal of Pediatric Dermatology AJPD. 2021; 4 (1): 2.

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm neonates who receive colloid assessed by rash scale score.	Mild degree of diaper rash score will mean improvement in diaper rash	four days