Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing <1500 g at Birth — CAPS  

Neonatal Sepsis Clinical Trial

Official title: Whole Body Cleansing With 0.25% Chlorhexidine at Birth for Prevention of Sepsis in Infants <1500 g: a Multi-center, Blinded, Randomized Trial

Status Withdrawn

Clinical Trial Summary

Purpose of this study is determine if skin application of chlorhexidine at birth would reduce infection in infants weighing <1500 g at birth.

Clinical Trial Description

Background

Infants weighing <1500 g at birth infants are more prone to acquire infections, often through their immature skin which serve as a portal of entry for invasive pathogens. Skin application of antiseptics such as chlorhexidine may reduce infections in these infants. However, there is a paucity of data on the safety and efficacy of such intervention in these infants.

Hypothesis:

Among hospitalized very low birth weight (VLBW; <1500 g) neonates, single whole body skin cleansing with 0.25% chlorhexidine within 6 hours after birth would reduce the incidence of sepsis in the first seven days of life from 25% to 17.5% (relative reduction of 30%) when compared to skin cleansing with sterile water

Objectives:

Primary- To evaluate the effect of whole body skin cleansing with 0.25% chlorhexidine (single application, at birth) on the incidence of sepsis (culture positive or culture negative) compared to sterile water cleansing in the first week of life in VLBW infants

Secondary- to compare following outcomes in this experiment:

1. Culture-confirmed sepsis within the first week of life

2. Need for repeat hospital admissions within first 28 days of life

3. Mortality within first 28 days of life

4. Cold stress/hypothermia at 0, 5, 15 and 30 minutes of intervention

5. Skin condition at 24 h of life

6. Colonization rates (subset)

7. Serum levels of chlorhexidine (subset)

Methods:

Eligible infants would be randomized within 6 hours of birth to either whole body skin cleansing with chlorhexidine (specially prepared wipes releasing 0.25% chlorhexidine), or sterile water (placebo). The research staff would collect the baseline data, record the axillary temperature and assess the skin condition using the Newborn Skin Condition Scoring (NSCS)score. The research team would follow the infants for development of sepsis and other outcomes. The infants would be subjected to detailed sepsis work up on clinical suspicion of sepsis, until 28 days of life.

Sepsis would be defined based on combination of clinical course, indirect markers, bacterial culture results and antibiotic treatment status. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neonatal Mortality Rate
• Neonatal Sepsis
• Sepsis

• NCT number: NCT01723501
• Study type: Interventional
• Source: All India Institute of Medical Sciences, New Delhi
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: November 2012