Topical Therapy for Prevention of Infections in Preterm Infants

Skin Diseases Clinical Trial

Official title:

Topical Emollient Therapy for Prevention of Infections in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162747
• Other study ID #: 98-04-21-03-2
• Secondary ID: H990772914-2123
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: September 11, 2005
• Start date: December 2001
• Est. completion date: June 2005

Study information

• Verified date: June 2005
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine how to best take care of the skin of preterm infants in order to prevent infections through the skin.

Description:

The skin of babies who are born too early is not mature, which means they are at risk for infections of the skin or in the body. Their skin also become very dry, leading to cracking and breakdown, and this may feel painful or uncomfortable for the infant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Months to 8 Months

Eligibility

Inclusion Criteria:

• Preterm infants

Exclusion Criteria:

• Full-term infant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Skin Diseases

Intervention

Drug:
• Aquaphor

• Sunflower Seed Oil

Locations

Country	Name	City	State
Bangladesh	Dhaka Shishu Hospital	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Three weeks after application of the intervention, blood will be drawn from those enrolled in the control group.
Secondary	Atleast four additional times over the first four weeks of the child's life, the skin will be studied by lightly rubbing the skin with a cotton swab to detect germs on the skin and observing and recording the condition of the baby's skin.