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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Delhi
-
New Delhi, Delhi, Inde, 110029
- All India Institute of Medical Sciences
-
New Delhi, Delhi, Inde, 110002
- Maulana Azad Medical College
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New Delhi, Delhi, Inde, 110029
- Vardhman Medical College and Safdarjung Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: sterile water
sterile water wipes
|
Sterile water wipes (placebo)
|
|
Expérimental: 0.25% chlorhexidine
0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine
|
0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sepsis within first 7 days of life
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Readmissions & mortality rates within neonatal period
Délai: 28 days
|
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
Délai: 30 minutes
|
Axillary temperature would be monitored with thermometer at above time points for full three minutes.
|
30 minutes
|
|
Skin condition
Délai: 24 ±6 hours
|
Newborn Skin Condition Score (NSCS)will be used to assess the skin condition.
|
24 ±6 hours
|
|
Skin colonization rates
Délai: 24 ±6 hours
|
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
Délai: 48 ±6 hours
|
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
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Vinod K Paul, MD, PhD, All India Institute of Medical Sciences, New Delhi
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NHKC-Chx2012
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