Not Signed In -
Skin Diseases (General) |
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Clinical Trial: Topical Therapy for Prevention of Infections in Preterm Infants
This study has been completed.
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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
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:
Primary Outcomes: Three weeks after application of the intervention, blood will be drawn from those enrolled in the control group.
Secondary Outcomes: 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.
Expected Total Enrollment: 600
Secondary Outcomes: 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.
Expected Total Enrollment: 600
Study start: December 2001
Last follow-up: June 2005
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 - 8 Months, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Preterm infants
Exclusion Criteria:
- Full-term infant
Location Information
Bangladesh
Dhaka Shishu Hospital, Dhaka, Bangladesh
Study chairs or principal investigators
Gary L Darmstadt, MD, Principal Investigator, Johns Hopkins Bloomberg School of Public Health
More Information
Study ID Numbers: 98-04-21-03-2; H990772; 914-2123
Last Updated: September 12, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00162747
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 12, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00162747
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Mastocytosis (National Institute of Allergy and Infectious Diseases)
- NIGMS-Supported Basic Research on Skin Replacement Following Burn or Trauma Injury (National Institute of General Medical Sciences)
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