Diaper RashPhase 4NCT05892081
Colloidal Oatmeal, Colloid Cream, Diaper Rash, Preterm Neonates and Neonatal Intensive Care Unit
A Phase 4 study testing Colloidal oatmeal and Cold cream in people with Diaper Rash and Preterm Neonates, run by Seham El-Sayed Saleh Hassan at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 34 to 37 weeks
- Conditions the study is for
- Diaper Rash, Preterm Neonates
- What is being tested?
- Colloidal oatmeal and Cold cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2021to 30 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Preterm who have candida infection in groin
- Use other drugs for diaper rash
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Diaper Rash, Preterm Neonates
- Being tested
- Colloidal oatmeal, Cold cream
- Keywords
- Colloidal oatmeal, Diaper rash, Preterm neonates
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Colloidal oatmeal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm neonates who receive colloid assessed by rash scale score.
Mild degree of diaper rash score will mean improvement in diaper rash
Measured: four days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start20 Aug 2021
- Primary completion12 Jan 2022
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Diaper RashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seham El-Sayed Saleh Hassan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seham El-Sayed Saleh Hassan, Matrouh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892081
- Sponsor's protocol ID
- Document attached-Not given
- Status last verified
- Sep 2023
- First submitted
- 11 Apr 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Academy of Pediatrics. (2014). Diaper rash. Available from: http//www.pdf secret.com _diaper-rash-southwest-childrens-center.pdf.
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.
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, 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.
PubMed 26919683Blume-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.
PubMed 24890321Boyles, 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.
PubMed 27653955Burdall 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.
PubMed 30506880Chat, 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.
PubMed 27834525Furber 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.
PubMed 22822929Gregorio 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.
PubMed 27272074
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colloidal Oatmeal Compared to Colloid Cream on Diaper Rash Among Preterm Neonates in the Neonatal Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT05892081
- Acronym / sponsor ID
- Document attached-Not given
- Conditions
- Diaper Rash, Preterm Neonates
- Keywords
- Colloidal oatmeal, Diaper rash, Preterm neonates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seham El-Sayed Saleh HassanUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
-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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group received the usual care of the unit. |
| Colloid group | Experimental | Biological: Cold creamReceived cold cream three times a day on the rash area while diaper changing by the researcher plus the usual care |
| Colloid oatmeal group | Experimental | Biological: Colloidal oatmealReceived colloid oatmeal cream three times a day on the rash area while diaper changing by the researcher plus the usual care |
Who may qualify
- Ages
- 34 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Preterm neonates
- Have diaper rash,
- Hemodynamically stable
- Receive enteral feeding (breast, bottle, gavage, or mixed feeding)
- Newly admitted to the previously mentioned setting
Key exclusion criteria (2 listed)
- Preterm who have candida infection in groin
- Use other drugs for diaper rash
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colloidal oatmealThe 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 | Biological | Colloid oatmeal group |
| Cold creamIt 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 | Biological | Colloid group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- BackgroundAmerican Academy of Pediatrics. (2014). Diaper rash. Available from: http//www.pdf secret.com _diaper-rash-southwest-childrens-center.pdf.
- BackgroundAltmann 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.
- BackgroundAssociation of Women's Health, Obstetric and Neonatal Nurses (AWHONN). Neonatal skin care evidence-based clinical practice guideline (3rd ed.). Washington, DC; (2013).
- BackgroundBaudouin 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: PubMed 26919683Blume-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.
- Background: PubMed 24890321Blume-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.
- BackgroundBoyles, 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: PubMed 27653955Buckley 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.
- Background: PubMed 30506880Burdall 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.
- BackgroundChat, 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: PubMed 27834525Collier 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.
- Background: PubMed 22822929Furber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colloidal oatmeal and Cold cream in people with Diaper Rash and Preterm Neonates, run by Seham El-Sayed Saleh Hassan at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm neonates who receive colloid assessed by rash scale score. (time frame: four days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05892081, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.