Efficacy of petroleum jelly in the prevention of irritant diaper dermatitis
| ISRCTN | ISRCTN00356649 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00356649 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/10/2010
- Registration date
- 09/11/2010
- Last edited
- 09/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jose Ignacio Emparanza
Scientific
Scientific
Clinical Epiedemiology Unit.
Donostia Hospital
Pº Dr Beguristain 107-115
San Sebastian
20014
Spain
Study information
| Study design | Randomised controlled double blind parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled double blind trial with parallel groups of newborn children admitted to the neonatal unit randomised to petroleum jelly or usual care for the prevention of irritant diaper dermatitis |
| Study objectives | The use of petroleum jelly as a barrier method, easy to use and easy removal, high visibility in the area of skin that covers and low cost, can help to decrease the incidence of diaper dermatitis, providing greater comfort to the child, reducing worry and anxiety of parents and in turn creating a greater degree of satisfaction among nursing staff at the unit. |
| Ethics approval(s) | Clinical Research Ethics Committee of Guipuzcoa Health Area approved on the 21st June 2010 |
| Health condition(s) or problem(s) studied | Irritant dermatitis |
| Intervention | Experimental group: Application of petroleum jelly to the infants after each diaper change. The amount of product to use is between 1 - 2 ml (depending on the weight of the child), the size of a hazelnut and will run for the perianal area and perineum. Control group: Usual care. Diaper changes as usual (like the other group), but not application of petroleum jelly. Both interventions and follow up will end at discharge. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Petroleum jelly |
| Primary outcome measure | Occurrence and time of diaper dermatitits using the Lane and Drost Scale. The existence of diaper dermatitis will be assessed every day during medical ward round. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/12/2010 |
| Completion date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 103 |
| Key inclusion criteria | 1. Neonates admitted to the Neonatal Unit of the Hospital Donostia in the area of media care 2. Newborns greater than or equal to 1500 grams at birth 3. Infants whose stay in the unit is between 4 and 21 days 4. Both genders will be included during neonatal period from 0 to 1 month |
| Key exclusion criteria | 1. Newborn from the Neonatal Intensive Care 2. Newborn with diaper dermatitis in the admission 3. Neonate admitted that less than 4 days 4. A newborn with pathology or alterations in skin integrity 5. Newborn under insolation 6. Newborn carrier catheterisation 7. Newborn transferred to intensive care because of worsening |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 01/12/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
Clinical Epiedemiology Unit.
San Sebastian
20014
Spain
20014
Spain
Sponsor information
Hospital Donostia (Osakidetza) (Spain)
Hospital/treatment centre
Hospital/treatment centre
Pº Doctor Beguiristain 107-115
San Sebastian
20014
Spain
| Website | http://www.osakidetza.euskadi.net |
|---|---|
"ROR" |
https://ror.org/04fkwzm96 |
Funders
Funder type
Hospital/treatment centre
Hospital Donostia (Osakidetza) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
