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

Neonatal Sepsis Clinical Trial

— CAPS  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01723501
• Other study ID #: NHKC-Chx2012
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: November 6, 2012
• Last updated: July 15, 2016
• Start date: November 2012

Study information

• Verified date: July 2016
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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 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

Intervention

Drug:
• 0.25% chlorhexidine
0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application
• sterile water
Sterile water wipes (placebo)

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi
India	Maulana Azad Medical College	New Delhi	Delhi
India	Vardhman Medical College and Safdarjung Hospital	New Delhi	Delhi

Sponsors (3)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi	Maulana Azad Medical College, Vardhman Mahavir Medical College And Safdarjung Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Skin condition	Newborn Skin Condition Score (NSCS)will be used to assess the skin condition.	24 ±6 hours	Yes
Secondary	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	No
Secondary	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	Yes

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