Topical Therapy for Prevention of Infections in Preterm Infants

This study has been completed.

First Received: September 7, 2005 Last Updated: September 11, 2005 History of Changes

Sponsored by:	Johns Hopkins Bloomberg School of Public Health
Information provided by:	Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00162747

Purpose

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.

Condition	Intervention	Phase
Skin Diseases	Drug: Aquaphor Drug: Sunflower Seed Oil	Phase IV

MedlinePlus related topics: Skin Conditions

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Topical Emollient Therapy for Prevention of Infections in Preterm Infants

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:

Three weeks after application of the intervention, blood will be drawn from those enrolled in the control group.

Secondary Outcome Measures:

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.

Estimated Enrollment:	600
Study Start Date:	December 2001
Estimated Study Completion Date:	June 2005

Detailed 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.

Eligibility

Ages Eligible for Study:	7 Months to 8 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Preterm infants

Exclusion Criteria:

Full-term infant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162747

Locations

Bangladesh
Dhaka Shishu Hospital
Dhaka, Bangladesh

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

Investigators

Principal Investigator:

Gary L Darmstadt, MD

Johns Hopkins Bloomberg School of Public Health

More Information

No publications provided

Study ID Numbers:	98-04-21-03-2, H990772, 914-2123
Study First Received:	September 7, 2005
Last Updated:	September 11, 2005
ClinicalTrials.gov Identifier:	NCT00162747 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

Pre-term infants
skin infections
infant skin
Aquaphor

sunflower seed oil
nutrition
skin care

Study placed in the following topic categories:

Skin Diseases, Infectious
Skin Diseases
Emollients

Additional relevant MeSH terms:

Skin Diseases
Infection

ClinicalTrials.gov processed this record on May 06, 2009