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Topical Therapy for Prevention of Infections in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00162747
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : September 13, 2005
Sponsor:
Information provided by:
Johns Hopkins Bloomberg School of Public Health

Brief 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.

Condition or disease Intervention/treatment Phase
Skin Diseases Drug: Aquaphor Drug: Sunflower Seed Oil Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Topical Emollient Therapy for Prevention of Infections in Preterm Infants
Study Start Date : December 2001
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions




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

Secondary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Months to 8 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Preterm infants

Exclusion Criteria:

  • Full-term infant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162747


Locations
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Bangladesh
Dhaka Shishu Hospital
Dhaka, Bangladesh
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
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Principal Investigator: Gary L Darmstadt, MD Johns Hopkins Bloomberg School of Public Health
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ClinicalTrials.gov Identifier: NCT00162747    
Other Study ID Numbers: 98-04-21-03-2
H990772
914-2123
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: September 13, 2005
Last Verified: June 2005
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:
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Infection
Skin Diseases