Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants

NCT00947518 | Completed Results

• 1 other identifier: 10/2004
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine affects skin condition, temperature, and bacterial colonization in stable preterm (28-36 weeks gestational age) low birth weight (1001-2000 g) infants admitted in a health facility.

Conditions

Neonatal Sepsis; Low Birth Weight

Keywords

chlorhexidine; preterm; newborn; skin condition; temperature; skin flora

Outcome Measures

Primary Outcomes (3)

• Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al

  The skin condition grading scale assesses the condition of the skin on the abdomen and dorsum of the hands/feet based on drying, erythema, crusting, oozing, etc. on a continuous scale from 1 (normal) to 9 (vesicles or pustules)

  At 24 hours

• Skin Temperature at 30 Min After Intervention

  Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes

  at 30 min after intervention

• Number of Participants With Positive Skin Culture at Axilla

  Occurrence of any bacterial flora irrespective of the colony count in the skin swabs from axilla at 24 hrs after intervention

  24 hours after intervention

Secondary Outcomes (1)

• Incidence of Clinical and Culture Positive Sepsis

  First week of life

Study Arms (3)

Chlorhexidine skin cleansing

EXPERIMENTAL

Wiping the skin (except the face) once immediately after birth using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)

Drug: Chlorhexidine

Saline skin cleansing

PLACEBO COMPARATOR

Wiping the skin (except the face) once immediately after birth using baby wipes containing normal saline

Drug: Normal saline

No skin cleansing

NO INTERVENTION

No skin application

Interventions

Chlorhexidine DRUG

Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)

Chlorhexidine skin cleansing

Normal saline DRUG

Cleansing the skin (except the face)with baby wipes containing normal saline

Saline skin cleansing

Eligibility Criteria

• Age: 1 Hour - 3 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants of 28 to 36 weeks' gestation
• Birth weights between 1001 and 2000 g

You may not qualify if:

• Infants with one minute Apgar score \< 4
• Hemodynamic instability
• Congenital malformations
• Generalized skin disorder and
• Infants who need respiratory support (continuous positive airway pressure and/or intermittent mandatory ventilation) in the first 2-3 hours of life

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

MeSH Terms

Conditions

Neonatal Sepsis; Premature Birth; Skin Diseases

Interventions

Chlorhexidine; Saline Solution

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Mari Jeeva Sankar
• Organization: Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

jeevasankar@gmail.com

+91-11-26594372

Study Officials

• Mari J Sankar, MD DM

  Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

  PRINCIPAL INVESTIGATOR

• Vinod K Paul, MD PhD

  Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

  STUDY CHAIR

• Ashok K Deorari, MD MNAMS

  Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

  STUDY CHAIR

• Gary L Darmstadt, MD MS

  Department of International Health, Bloomberg School of Public Health, Johns Hopkins University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: July 28, 2009
• Study Start: August 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: June 25, 2018
• Results First Posted: July 28, 2009

Record last verified: 2009-06