## Protocol Section
### Identification Module
**NCT ID:** NCT00198679

**Brief Title:** Effect of Chlorhexidine Skin Cleansing on Skin Flora

**Official Title:** Effect of Chlorhexidine Skin Cleansing on Skin Flora of Newborn Infants in Bangladesh

#### Organization Study ID Info
**ID:** H.22.03.10.07.A2
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins Bloomberg School of Public Health
### Status Module
#### Completion Date
**Date:** 2005-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-04-20

**Type:** ACTUAL

**Last Update Submit Date:** 2018-04-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2005-03

**Type:** ACTUAL

#### Start Date
**Date:** 2004-03

**Status Verified Date:** 2006-05

#### Study First Post Date
**Date:** 2005-09-20
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-12
**Study First Submit QC Date:** 2005-09-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Johns Hopkins Bloomberg School of Public Health

### Description Module

**Brief Summary:** Given the potential of skin cleansing with chlorhexidine as a safe, feasible, and cost-effective intervention for reducing neonatal death in developing country settings, this study follows a trial already underway in Nepal to test the impact of a single cleansing of the skin with baby wipes cotaining chlorahexidine.

**Detailed Description:** This study is designed to test the impact of a single cleansing of the skin with 0.25% or 4.0% Chlorhexidine wipes on qualitative and quantitative skin flora and skin condition in newborn infants. The study takes place in the Special Care Nursery at Dhaka Shishu Hospital in Dhaka, Bangladesh.

### Conditions Module

**Conditions:**

- Skin Diseases, Infectious

**Keywords:**

- skin cleansing

- Bangladesh

- Skin Flora

- Newborn

- infectious disease

- chlorhexidine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 210

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Chlorhexidine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Wiping of newborn skin will be done immediatly upon enrollment in study, with follow up during hosptial stay and up to two weeks to determine skin condition and presence of any kind of skin infection.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Infant admitted to Special Care Nursery at Dhaka Shishu Hospital less than 48 hours chronological age
* parental consent must be obtained

Exclusion Criteria:

* infants being admitted for major surgical procedure which is attended by high rate of infectious complications
* sepsis
* clinically-evident skin infection
* generalized skin disease
* structural defect of the skin involving greater than 5% of the body surface
* with a major congenital anomaly
* with a known immunodeficiency

**Healthy Volunteers:** True

**Maximum Age:** 48 Hours

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Dhaka

**Country:** Bangladesh

**Facility:** Dhaka Shishu Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Johns Hopkins Bloomberg School of Public Health

**Name:** Gary Darmstadt, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Diseases, Infectious

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Diseases, Infectious

- ID: M15674

- Name: Skin Diseases

- Relevance: HIGH

- As Found: Skin Diseases

- ID: M15677

- Name: Skin Diseases, Infectious

- Relevance: HIGH

- As Found: Skin Diseases, Infectious

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000012874

- Term: Skin Diseases, Infectious

- ID: D000012871

- Term: Skin Diseases

### Intervention Browse Module - Ancestors

- ID: D000000891

- Term: Anti-Infective Agents, Local

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000004202

- Term: Disinfectants

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M5953

- Name: Chlorhexidine

- Relevance: HIGH

- As Found: Digital

- ID: M344731

- Name: Chlorhexidine gluconate

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4215

- Name: Anti-Infective Agents, Local

- Relevance: LOW

- As Found: Unknown

- ID: M7383

- Name: Disinfectants

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002710

- Term: Chlorhexidine

### Misc Info Module

- Version Holder: 2024-05-24
