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Efficacy of petroleum jelly in the prevention of irritant diaper dermatitis

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN00356649
Enrollment
103
Registered
2010-11-09
Start date
2010-12-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritant dermatitis Skin and Connective Tissue Diseases Dermatitis

Interventions

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 haze

Sponsors

Hospital Donostia (Osakidetza) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026