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

15. juli 2016 opdateret af: Dr Vinod K Paul, All India Institute of Medical Sciences, New Delhi

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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 4 uger (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: sterile water
sterile water wipes
Medicin: sterile water
Sterile water wipes (placebo)
Eksperimentel: 0.25% chlorhexidine
0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine
Medicin: 0.25% chlorhexidine
0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application
Andre navne:
  • Chx

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sepsis within first 7 days of life
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Readmissions & mortality rates within neonatal period
Tidsramme: 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
Tidsramme: 30 minutes
Axillary temperature would be monitored with thermometer at above time points for full three minutes.
30 minutes
Skin condition
Tidsramme: 24 ±6 hours
Newborn Skin Condition Score (NSCS)will be used to assess the skin condition.
24 ±6 hours
Skin colonization rates
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

All India Institute of Medical Sciences, New Delhi

Samarbejdspartnere

Maulana Azad Medical College
Vardhman Mahavir Medical College And Safdarjung Hospital

Efterforskere

  • Ledende efterforsker: Vinod K Paul, MD, PhD, All India Institute of Medical Sciences, New Delhi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2012

Datoer for studieregistrering

Først indsendt

6. november 2012

Først indsendt, der opfyldte QC-kriterier

6. november 2012

Først opslået (Skøn)

8. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NHKC-Chx2012

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Neonatal sepsis

Kliniske forsøg med sterile water

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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