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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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:
- Culture-confirmed sepsis within the first week of life
- Need for repeat hospital admissions within first 28 days of life
- Mortality within first 28 days of life
- Cold stress/hypothermia at 0, 5, 15 and 30 minutes of intervention
- Skin condition at 24 h of life
- Colonization rates (subset)
- 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.
Tipo de estudo
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
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Delhi
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New Delhi, Delhi, Índia, 110029
- All India Institute of Medical Sciences
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New Delhi, Delhi, Índia, 110002
- Maulana Azad Medical College
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New Delhi, Delhi, Índia, 110029
- Vardhman Medical College and Safdarjung Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: sterile water
sterile water wipes
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Sterile water wipes (placebo)
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Experimental: 0.25% chlorhexidine
0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine
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0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sepsis within first 7 days of life
Prazo: First 7 days of life
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Sepsis would be defined on the basis of clinical course, lab parameters including culture results and antibiotic treatment given.
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First 7 days of life
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Readmissions & mortality rates within neonatal period
Prazo: 28 days
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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.
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28 days
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Body temperature at 0, 5, 15, 30 minutes after application
Prazo: 30 minutes
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Axillary temperature would be monitored with thermometer at above time points for full three minutes.
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30 minutes
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Skin condition
Prazo: 24 ±6 hours
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Newborn Skin Condition Score (NSCS)will be used to assess the skin condition.
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24 ±6 hours
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Skin colonization rates
Prazo: 24 ±6 hours
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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.
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24 ±6 hours
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Chlorhexidine percutaneous absorption
Prazo: 48 ±6 hours
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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.
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48 ±6 hours
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Vinod K Paul, MD, PhD, All India Institute of Medical Sciences, New Delhi
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NHKC-Chx2012
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