Clinical trial NCT01723501: Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing <1500 g at Birth
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Neonatal Sepsis
Neonatal Mortality Rate
Keywords: chlorhexidine
sepsis
neonatal
whole-body skin cleansing
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Maulana Azad Medical College
name: Vardhman Mahavir Medical College And Safdarjung Hospital
First posted: 2012-11-08
Enrollment: 0
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sepsis within first 7 days of life
timeFrame: First 7 days of life
Secondary outcomes:
measure: Readmissions & mortality rates within neonatal period
timeFrame: 28 days
measure: Body temperature at 0, 5, 15, 30 minutes after application
timeFrame: 30 minutes
measure: Skin condition
timeFrame: 24 ±6 hours
measure: Skin colonization rates
timeFrame: 24 ±6 hours
measure: Chlorhexidine percutaneous absorption
timeFrame: 48 ±6 hours
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Maulana Azad Medical College
state: Delhi
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: New Delhi
country: India
facility: Vardhman Medical College and Safdarjung Hospital
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Vinod K Paul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: