AzTrials
AzTrials

Diaper RashNCT05427760

Effect of Using Oxygen on the Diaper Dermatitis in Infants

A study testing Oxygen in people with Diaper Rash and Diaper Dermatitis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: Airing the diaper area has a positive effect on dermatitis. In addition, it is reported in the literature that oxygen is effective in wound care. The aim of our study is to investigate the effect of oxygen on infant diaper dermatitis. Read more about this study

Who is it for?
Ages 1 day to 28 daysHealthy volunteers can take part
Conditions the study is for
Diaper Rash, Diaper Dermatitis
What is being tested?
Oxygen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Oct 2022to 15 Apr 2023
Phase
Interventional
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 1 day to 28 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Approved by the family for the study
  • Born between 34-42. gestational weeks
  • No skin disease other than diaper dermatitis
  • No skin lesions of another disease other than dermatitis-related lesions in the gland area
  • Newborns who has stable vital signs

Who cannot join

  • Having a skin disease other than diaper dermatitis
  • Having a lesion on the skin due to another disease
  • Having a known skin allergy
  • Born before 34. gestational weeks
  • Having a gastrointestinal disease

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul University Cerrahpasa

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Background: Airing the diaper area has a positive effect on dermatitis. In addition, it is reported in the literature that oxygen is effective in wound care. The aim of our study is to investigate the effect of oxygen on infant diaper dermatitis.

Method: The study population consisted of infants will admit to the neonatal intensive care unit of a public hospital in Istanbul between October 2022 and April 2023. Sixty newborns who met the study criteria will randomly divide into two as the experimental (n=30) and control (n=30) groups. Personal data form and diaper dermatitis observation form will be used to obtain the data. All babies' diapers will be changed 8 times a day. Oxygen flow will be applied to the experimental group for one hour after each diaper change. The degree of diaper dermatitis will be evaluated every 24 hours.

Being tested
Oxygen
Keywords
infant, diaper dermatitis, diaper rash, oxygen
Medical subject headings
Diaper Rash

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxygenDrug

    After changing the diaper, free flow oxygen will be provided to the diaper area for 1 hour with an oxygen cannula placed inside the diaper (oxygen flow is %21 Fio2, 5 L/min)

Study groups in NCT05427760
Study groupRoleWhat they receive
Oxygen GroupExperimentalAfter the baby's diaper is changed, an oxygen hose placed inside the diaper will provide free oxygen flow to the diaper area. Oxygen will be applied for 1 hour at each diaper change at a flow rate of 5L/min and at a concentration of 21% FiO2 which is equivalent to room air.
Receives: Drug: Oxygen
Control GroupNo interventionThis group will only receive routine care: Diaper will be changed using disposable wet wipes and disposable baby diaper. A barrier cream containing 40% zinc oxide will be applied to the cleaned diaper area as a thin layer to cover the skin. Baby's diaper change will be done 8 times a day, every three hours.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diaper dermatitis healing scale result

    Expecting to healing diaper dermatitis symptoms at the time of intervention. The scale maximum value: 6 and minimum value: 0. As the scale score increases, the severity of dermatitis increases.

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2022
  2. Study start15 Oct 2022
  3. Primary completion15 Mar 2023
  4. Study completion15 Apr 2023

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05427760
Sponsor's protocol ID
386964
Status last verified
Sep 2023
First submitted
14 Jun 2022
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abels C, Angelova-Fischer I. Skin Care Products: Age-Appropriate Cosmetics. Curr Probl Dermatol. 2018;54:173-182. doi: 10.1159/000489531. Epub 2018 Aug 21.

    PubMed 30130785

  • Ahmed B, Solanki B, Zaidi A, Khan MS, Musarrat J. Bacterial toxicity of biomimetic green zinc oxide nanoantibiotic: insights into ZnONP uptake and nanocolloid-bacteria interface. Toxicol Res (Camb). 2018 Dec 26;8(2):246-261. doi: 10.1039/c8tx00267c. eCollection 2019 Mar 1.

    PubMed 30997024

  • Almoudi MM, Hussein AS, Abu Hassan MI, Mohamad Zain N. A systematic review on antibacterial activity of zinc against Streptococcus mutans. Saudi Dent J. 2018 Oct;30(4):283-291. doi: 10.1016/j.sdentj.2018.06.003. Epub 2018 Jun 18.

    PubMed 30202164

  • Amer M, Diab N, Soliman M, Amer A. Neonatal skin care: what should we do? A four-week follow-up randomized controlled trial at Zagazig University Hospitals. Int J Dermatol. 2017 Nov;56(11):1198-1203. doi: 10.1111/ijd.13735. Epub 2017 Sep 7.

    PubMed 28884798

  • Atherton DJ. Understanding irritant napkin dermatitis. Int J Dermatol. 2016 Jul;55 Suppl 1:7-9. doi: 10.1111/ijd.13334.

    PubMed 27311779

  • Baurecht H, Ruhlemann MC, Rodriguez E, Thielking F, Harder I, Erkens AS, Stolzl D, Ellinghaus E, Hotze M, Lieb W, Wang S, Heinsen-Groth FA, Franke A, Weidinger S. Epidermal lipid composition, barrier integrity, and eczematous inflammation are associated with skin microbiome configuration. J Allergy Clin Immunol. 2018 May;141(5):1668-1676.e16. doi: 10.1016/j.jaci.2018.01.019. Epub 2018 Feb 5.

    PubMed 29421277

  • Bender JK, Faergemann J, Skold M. Skin Health Connected to the Use of Absorbent Hygiene Products: A Review. Dermatol Ther (Heidelb). 2017 Sep;7(3):319-330. doi: 10.1007/s13555-017-0189-y. Epub 2017 Jun 30.

    PubMed 28667496

  • Bennardo L, Del Duca E, Dastoli S, Schipani G, Scali E, Silvestri M, Nistico SP. Potential applications of topical oxygen therapy in dermatology. Dermatol Pract Concept. 2018 Oct 31;8(4):272-276. doi: 10.5826/dpc.0804a04. eCollection 2018 Oct.

    PubMed 30479854

  • Blume-Peytavi U, Kanti V. Prevention and treatment of diaper dermatitis. Pediatr Dermatol. 2018 Mar;35 Suppl 1:s19-s23. doi: 10.1111/pde.13495.

    PubMed 29596731

  • 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.

    PubMed 24890321

  • 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 26919683

  • Bonifaz A, Rojas R, Tirado-Sanchez A, Chavez-Lopez D, Mena C, Calderon L, Maria PO. Superficial Mycoses Associated with Diaper Dermatitis. Mycopathologia. 2016 Oct;181(9-10):671-9. doi: 10.1007/s11046-016-0020-9. Epub 2016 May 19.

    PubMed 27193417

  • 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.

    PubMed 30506880

  • Caglar S, Yildiz GK, Bakoglu I, Salihoglu O. The Effect of Sunflower Seed and Almond Oil on Preterm Infant Skin: A Randomized Controlled Trial. Adv Skin Wound Care. 2020 Aug;33(8):1-6. doi: 10.1097/01.ASW.0000672500.18525.2e.

    PubMed 32697476

  • Carr AN, DeWitt T, Cork MJ, Eichenfield LF, Folster-Holst R, Hohl D, Lane AT, Paller A, Pickering L, Taieb A, Cui TY, Xu ZG, Wang X, Brink S, Niu Y, Ogle J, Odio M, Gibb RD. Diaper dermatitis prevalence and severity: Global perspective on the impact of caregiver behavior. Pediatr Dermatol. 2020 Jan;37(1):130-136. doi: 10.1111/pde.14047. Epub 2019 Dec 2.

    PubMed 31793090

Questions about this trial

What is this clinical trial studying?

A study testing Oxygen in people with Diaper Rash and Diaper Dermatitis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

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 5 inclusion and 5 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 18 Oct 2024. 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 Turkey (Türkiye). 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.

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?

Diaper dermatitis healing scale result (time frame: 72 hours). 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 NCT05427760, which also lists 123 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 18 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in