NCT00162747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

September 13, 2005

Status Verified

June 1, 2005

First QC Date

September 7, 2005

Last Update Submit

September 11, 2005

Conditions

Skin Diseases

Keywords

Pre-term infantsskin infectionsinfant skinAquaphorsunflower seed oilnutritionskin care

Outcome Measures

Primary Outcomes (1)

  • Three weeks after application of the intervention, blood will be drawn from those enrolled in the control group.

Secondary Outcomes (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.

Interventions

AquaphorDRUG
Sunflower Seed OilDRUG

Eligibility Criteria

Age7 Months - 8 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants

You may not qualify if:

  • Full-term infant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhaka Shishu Hospital

Dhaka, Bangladesh

Location

Related Publications (1)

  • 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.

    PMID: 34039435DERIVED

MeSH Terms

Conditions

Skin DiseasesCellulitis

Interventions

PetrolatumSunflower Oil

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesSkin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrocarbonsOrganic ChemicalsPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Gary L Darmstadt, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 13, 2005

Study Start

December 1, 2001

Study Completion

June 1, 2005

Last Updated

September 13, 2005

Record last verified: 2005-06

Locations

BA(1)