NCT05892081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

April 11, 2023

Last Update Submit

September 20, 2023

Conditions

Diaper RashPreterm Neonates

Keywords

Colloidal oatmealDiaper rashPreterm neonates

Outcome Measures

Primary Outcomes (1)

  • Preterm neonates who receive colloid assessed by rash scale score.

    Mild degree of diaper rash score will mean improvement in diaper rash

    four days

Study Arms (3)

Control group

NO INTERVENTION

The control group received the usual care of the unit.

Colloid group

EXPERIMENTAL

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

Biological: Cold cream

Colloid oatmeal group

EXPERIMENTAL

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

Interventions

Colloidal oatmealBIOLOGICAL

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

Colloid oatmeal group
Cold creamBIOLOGICAL

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

Colloid group

Eligibility Criteria

Age34 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matrouh university

Marsá Maţrūḩ, Egypt

Location

Related Publications (24)

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

    BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 26919683BACKGROUND

  • 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.

    PMID: 24890321BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 27653955BACKGROUND

  • 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.

    PMID: 30506880BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 27834525BACKGROUND

  • 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.

    PMID: 22822929BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 27272074BACKGROUND

  • 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.

    PMID: 25017459BACKGROUND

  • 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.

    PMID: 33632947BACKGROUND

  • 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.

    PMID: 26264797BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

  • Paller A , Mancini A. Hurwitz Clinical Pediatric Dermatology: A Textbook of Skin Disorders of Childhood and Adolescence. 6thEd. Elsevier Saunders, 2011.

    BACKGROUND

  • 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.

    PMID: 22606064BACKGROUND

  • 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.

    PMID: 22421643BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, IrritantDermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of pediatric nursing, faculty of nursing

Study Record Dates

First Submitted

April 11, 2023

First Posted

June 7, 2023

Study Start

August 20, 2021

Primary Completion

January 12, 2022

Study Completion

August 30, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)