Weekly Versus no Routine Ventilator Circuit Changes in NICU

Study Overview
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Brief Summary
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The purpose of this study is to determine incidence of ventilator-associated pneumonia compared between weekly and no routine ventilator circuit changes in neonatal intensive care unit

Detailed Description
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Parents were received informed consent. Enrolled neonates was randomly assigned to 2 groups as 7-day ventilator circuit change and no change group by computerization with allocated of concealment. The investigation team opened the next sequentially numbered study pack, which was stored in the neonatal unit. The assignment sequence was generated with balance within random block sizes of 4. Stratification according to birthweight was done before randomization to control for differences in patient populations. Patient characteristics were recorded as gestational age, sex, birthweight, underlying disease, date of intubation, date of extubation, duration of mechanical ventilator, reintubation, length of hospital stay, parenteral nutrition, medication (H2-blocker, PPI, narcotic drugs), transfusion and oral immune therapy. Laboratory data and radiographic data were recorded. Both groups received similarly care as the nurse was assigned to take care of patient in ratio 1-2 patients: 1 nurse, new disposable circuits were use in both groups and the VAP prevention protocol and the endotracheal suctioning protocol which followed by an American Academy of Respiratory Care (AARC) clinical practice guidelines were performed in both groups. When the VAP was suspected the radiographic data were reviewed by two pediatric radiologists on the day of diagnosis, 3 days prior to the diagnosis and/or 2 and 7 days after diagnosis to confirm diagnosis of VAP if there is different in the results, the consensus must be made.

Official Title
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Weekly Versus no Routine Ventilator Circuit Changes in Neonatal Intensive Care Unit: Prospective, Randomized Study

Conditions
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Pneumonia, Ventilator-Associated

Intervention / Treatment
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* Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All neonates who admitted at neonatal intensive care unit (NICU) and required ventilator support with both intubated at time of neonatal resuscitation and within the NICU as indicated Exclusion Criteria: Patient was extubated or died within 2 calendar days of endotracheal intubation Pneumonia was diagnosed before intubation Outborn who was intubated before referred Parents declined to participate Incompatibility of disposable circuits and ventilator Chromosome abnormality or moribund

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly ventilator circuit change<br>Ventilator circuit change every 7 days until extubation | Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber<br> <br> * Other names: Evaqua2, RT265;|
| Active Comparator: No routine ventilator circuit change<br>No routine ventilator circuit change until soiling or malfunction or extubation | Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber<br> <br> * Other names: Evaqua2, RT265;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of ventilator-associated pneumonia (percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant) | percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant | within the first 30 days (plus or minus 7 days) after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of ventilator-associated pneumonia (ventilator-associated pneumonia (events)/1,000 ventilator days) | ventilator-associated pneumonia (events)/1,000 ventilator days | within the first 30 days (plus or minus 7 days) after extubation | 
| Mortality rate | pneumonia-specific mortality within 7 days and at discharge | within the first 30 days (plus or minus 7 days) after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Newborn, Neonatal intensive care unit, Ventilator circuit