Topical Therapy for Prevention of Infections in Preterm Infants

September 11, 2005 updated by: Johns Hopkins Bloomberg School of Public Health

Topical Emollient Therapy for Prevention of Infections in Preterm Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Dhaka Shishu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 8 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Preterm infants

Exclusion Criteria:

  • Full-term infant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Investigators

  • Principal Investigator: Gary L Darmstadt, MD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

September 13, 2005

Last Update Submitted That Met QC Criteria

September 11, 2005

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-04-21-03-2
  • H990772
  • 914-2123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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