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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studie Locaties
-
-
Delhi
-
New Delhi, Delhi, Indië, 110029
- All India Institute of Medical Sciences
-
New Delhi, Delhi, Indië, 110002
- Maulana Azad Medical College
-
New Delhi, Delhi, Indië, 110029
- Vardhman Medical College and Safdarjung Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: sterile water
sterile water wipes
|
Sterile water wipes (placebo)
|
|
Experimenteel: 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
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sepsis within first 7 days of life
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Readmissions & mortality rates within neonatal period
Tijdsspanne: 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
Tijdsspanne: 30 minutes
|
Axillary temperature would be monitored with thermometer at above time points for full three minutes.
|
30 minutes
|
|
Skin condition
Tijdsspanne: 24 ±6 hours
|
Newborn Skin Condition Score (NSCS)will be used to assess the skin condition.
|
24 ±6 hours
|
|
Skin colonization rates
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Vinod K Paul, MD, PhD, All India Institute of Medical Sciences, New Delhi
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NHKC-Chx2012
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .