Condition category
Skin and Connective Tissue Diseases
Date applied
08/10/2010
Date assigned
09/11/2010
Last edited
09/11/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Ignacio Emparanza

ORCID ID

Contact details

Clinical Epiedemiology Unit.
Donostia Hospital
Pº Dr Beguristain 107-115
San Sebastian
20014
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

Clinical Research Ethics Committee of Guipuzcoa Health Area approved on the 21st June 2010

Study design

Randomised controlled double blind parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Petroleum jelly

Primary outcome measures

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 trial start date

01/12/2010

Overall trial end date

01/12/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

103

Participant 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

Recruitment start date

01/12/2010

Recruitment end date

01/12/2011

Locations

Countries of recruitment

Spain

Trial participating centre

Clinical Epiedemiology Unit.
San Sebastian
20014
Spain

Sponsor information

Organisation

Hospital Donostia (Osakidetza) (Spain)

Sponsor details

Pº Doctor Beguiristain 107-115
San Sebastian
20014
Spain

Sponsor type

Hospital/treatment centre

Website

http://www.osakidetza.euskadi.net

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital Donostia (Osakidetza) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes