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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Neonatal Sepsis; Neonatal Mortality Rate
• Intervention / Treatment: Drug: sterile water; Drug: 0.25% chlorhexidine

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110029
      • All India Institute of Medical Sciences
    • New Delhi, Delhi, India, 110002
      • Maulana Azad Medical College
    • New Delhi, Delhi, India, 110029
      • Vardhman Medical College and Safdarjung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: sterile water; sterile water wipes	Drug: sterile water; Sterile water wipes (placebo)
Experimental: 0.25% chlorhexidine; 0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine	Drug: 0.25% chlorhexidine; 0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application; Other Names: Chx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sepsis within first 7 days of life	Sepsis would be defined on the basis of clinical course, lab parameters including culture results and antibiotic treatment given.	First 7 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmissions & mortality rates within neonatal period	The re-admissions & mortality rates within neonatal period in these infants will be prospectively recorded during hospital admission as well as follow up. The follow up includes telephonic contact as well as home visits and verbal autopsy in cases of deaths at home.	28 days
Body temperature at 0, 5, 15, 30 minutes after application	Axillary temperature would be monitored with thermometer at above time points for full three minutes.	30 minutes
Skin condition	Newborn Skin Condition Score (NSCS)will be used to assess the skin condition.	24 ±6 hours
Skin colonization rates	In a sub-group of infants, skin swabs will be collected at baseline and 24 ±6 hours and sent to microbiology lab; colonization rates would be determined by semi-quantitative methods.	24 ±6 hours
Chlorhexidine percutaneous absorption	Serum chlorhexidine levels will be assayed in a sub-set to assess the extent of percutaneous absorption. 5ml of blood will be stored at -80 deg. C till transport to the lab. Samples will be processed in batches as per standard protocol to determine the levels.	48 ±6 hours

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborators: Maulana Azad Medical College; Vardhman Mahavir Medical College And Safdarjung Hospital
• Investigators: Principal Investigator: Vinod K Paul, MD, PhD, All India Institute of Medical Sciences, New Delhi

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2012

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: November 6, 2012
• First Posted (Estimate): November 8, 2012

Study Record Updates

• Last Update Posted (Estimate): July 18, 2016
• Last Update Submitted That Met QC Criteria: July 15, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: sepsis; chlorhexidine; neonatal; whole-body skin cleansing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Neonatal Sepsis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: NHKC-Chx2012