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

All India Institute Of Medical Science (AIIMS)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Neonatal Mortality Rate; Neonatal Sepsis

Treatments: Drug: 0.25% chlorhexidine; Drug: sterile water

Study type: Interventional

Funder types: Other

Identifiers

NCT01723501

NHKC-Chx2012

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

sterile water

Placebo Comparator group

Description:

sterile water wipes

Treatment:

Drug: sterile water

0.25% chlorhexidine

Experimental group

Description:

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

Treatment:

Drug: 0.25% chlorhexidine