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Topical Therapy for Prevention of Infections in Preterm Infants

Primary Purpose

Skin Diseases

Status
Completed
Phase
Phase 4
Locations
Bangladesh
Study Type
Interventional
Intervention
Aquaphor
Sunflower Seed Oil
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Diseases focused on measuring Pre-term infants, skin infections, infant skin, Aquaphor, sunflower seed oil, nutrition, skin care

Eligibility Criteria

7 Months - 8 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Preterm infants Exclusion Criteria: Full-term infant

Sites / Locations

  • Dhaka Shishu Hospital

Outcomes

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.

Full Information

First Posted
September 7, 2005
Last Updated
September 11, 2005
Sponsor
Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT00162747
Brief Title
Topical Therapy for Prevention of Infections in Preterm Infants
Official Title
Topical Emollient Therapy for Prevention of Infections in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases
Keywords
Pre-term infants, skin infections, infant skin, Aquaphor, sunflower seed oil, nutrition, skin care

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aquaphor
Intervention Type
Drug
Intervention Name(s)
Sunflower Seed Oil
Primary Outcome Measure Information:
Title
Three weeks after application of the intervention, blood will be drawn from those enrolled in the control group.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Preterm infants Exclusion Criteria: Full-term infant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary L Darmstadt, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dhaka Shishu Hospital
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
34039435
Citation
Darmstadt GL, Khan NZ, Rosenstock S, Muslima H, Parveen M, Mahmood W, Ahmed ASMNU, Chowdhury MAKA, Zeger S, Saha SK. Impact of emollient therapy for preterm infants in the neonatal period on child neurodevelopment in Bangladesh: an observational cohort study. J Health Popul Nutr. 2021 May 26;40(1):24. doi: 10.1186/s41043-021-00248-9.
Results Reference
derived

Learn more about this trial

Topical Therapy for Prevention of Infections in Preterm Infants

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