Efficacy of petroleum jelly in the prevention of irritant diaper dermatitis

ISRCTN	ISRCTN00356649
DOI	https://doi.org/10.1186/ISRCTN00356649
Protocol serial number	N/A
Sponsor	Hospital Donostia (Osakidetza) (Spain)
Funder	Hospital Donostia (Osakidetza) (Spain)

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

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

Study information

Primary study design	Interventional
Study design	Randomised controlled double blind parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Petroleum jelly
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/12/2011

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes