Topical Therapy for Prevention of Infections in Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00162747
First received: September 7, 2005
Last updated: September 11, 2005
Last verified: June 2005
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Topical Emollient Therapy for Prevention of Infections in Preterm Infants

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00162747     History of Changes
Other Study ID Numbers: 98-04-21-03-2, H990772, 914-2123
Study First Received: September 7, 2005
Last Updated: September 11, 2005
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

Additional relevant MeSH terms:
Skin Diseases
Petrolatum
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014