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Completed

NCT Number: NCT02614248

The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population

The purpose of the study is to examine the safety and effectiveness of the use of coconut oil for the prevention and treatment of diaper dermatitis among NICU babies at Genesis Medical Center, Davenport.

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Key information

Conditions

Dermatitis, Contact Dermatitis Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

5 hour–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Genesis Medical Center, East Campus

Davenport, Iowa, 52803, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Babies admitted to the Genesis NICU
  • Anticipated stay in the NICU is ≥ 48 hours
  • Babies wearing diapers 24 hours a day
  • Parent willing to sign informed consent for the study
  • Parent willing to use the test products in the diaper area during the trial
  • Parent willing to not change the type or brand of diaper and wipes during the study
  • Parent willing to refrain from changing any other products whose use may have an effect of their baby's skin condition during the trial

Exclusion criteria

  • Babies with a gestational age <30 weeks
  • Babies with major congenital malformations
  • Active dermatological conditions other than diaper dermatitis that may affect trial results
  • Known sensitivity to ingredients in trial products
  • Babies whose parents have a hazelnut or coconut allergy
  • Other severe acute medical conditions that may increase the risk associated with trial participation

Treatment and study plan

Organic, Unrefined Coconut Oil

Other

Medline Remedy Phytoplex Z-Guard Skin Protectant

Other

Primary outcomes

  1. The Number of Days Free From Diaper Dermatitis

    Time frame: Once, at hospital discharge, an average of 2 weeks

    The number of days free from diaper dermatitis.

  2. The Number of Patients Experiencing Adverse Events

    Time frame: Once, at hospital discharge, an average of 2 weeks

    The number of patients experiencing adverse events.

Secondary outcomes

  1. The Percent of Parents Stating Satisfaction With the Diaper Dermatitis Treatment Used

    Time frame: Once, at study completion for hospital discharge, an average of 2 weeks

    The percent of parents stating satisfaction with the diaper dermatitis treatment used Measured by a parent satisfaction survey

Sponsors and collaborators

Lead sponsor

Genesis Health System

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 25, 2015
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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