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

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

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Neonatal Sepsis Neonatal Mortality Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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sterile water

sterile water wipes

Group Type PLACEBO_COMPARATOR

sterile water

Intervention Type DRUG

Sterile water wipes (placebo)

0.25% chlorhexidine

0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine

Group Type EXPERIMENTAL

0.25% chlorhexidine

Intervention Type DRUG

0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application

Interventions

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0.25% chlorhexidine

0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application

Intervention Type DRUG

sterile water

Sterile water wipes (placebo)

Intervention Type DRUG

Other Intervention Names

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Chx

Eligibility Criteria

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Inclusion Criteria

* Birth weight less than 1500 g

Exclusion Criteria

* Birth weight \<750 g
* Major congenital malformations
* Total duration of positive pressure ventilation (PPV) \> 3 mins OR chest compressions
* Shock- requiring inotropes \>10 mic/kg/min

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No