Weekly Versus no Routine Ventilator Circuit Changes in NICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-03-31

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

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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.

Conditions

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Pneumonia, Ventilator-Associated

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Weekly ventilator circuit change

Ventilator circuit change every 7 days until extubation

Group Type EXPERIMENTAL

Infant Ventilator Circuit Dual Heated with Autofeed Chamber

Intervention Type DEVICE

No routine ventilator circuit change

No routine ventilator circuit change until soiling or malfunction or extubation

Group Type ACTIVE_COMPARATOR

Infant Ventilator Circuit Dual Heated with Autofeed Chamber

Intervention Type DEVICE

Interventions

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Infant Ventilator Circuit Dual Heated with Autofeed Chamber

Intervention Type DEVICE

Other Intervention Names

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Evaqua2, RT265

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No