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Topical Therapy for Prevention of Infections in Preterm Infants

NCT ID: NCT00162747

Last Updated: 2005-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Skin Diseases

Keywords

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Pre-term infants skin infections infant skin Aquaphor sunflower seed oil nutrition skin care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Aquaphor

Intervention Type DRUG

Sunflower Seed Oil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Preterm infants

Exclusion Criteria

* Full-term infant
Minimum Eligible Age

7 Months

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Principal Investigators

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Gary L Darmstadt, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Dhaka Shishu Hospital

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

References

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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.

Reference Type DERIVED
PMID: 34039435 (View on PubMed)

Other Identifiers

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H990772

Identifier Type: -

Identifier Source: secondary_id

914-2123

Identifier Type: -

Identifier Source: secondary_id

98-04-21-03-2

Identifier Type: -

Identifier Source: org_study_id