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Weekly Versus no Routine Ventilator Circuit Changes in NICU

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02326207
Enrollment
19
Registered
2014-12-25
Start date
2015-04-30
Completion date
2017-03-31
Last updated
2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Ventilator-Associated

Keywords

Infant, Newborn, Neonatal intensive care unit, Ventilator circuit

Brief summary

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

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.

Interventions

DEVICEInfant Ventilator Circuit Dual Heated with Autofeed Chamber

Sponsors

Prince of Songkla University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of ventilator-associated pneumonia (percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant)within the first 30 days (plus or minus 7 days) after extubationpercentage of ventilator-associated pneumonia (events)/mechanically ventilated infant

Secondary

MeasureTime frameDescription
incidence of ventilator-associated pneumonia (ventilator-associated pneumonia (events)/1,000 ventilator days)within the first 30 days (plus or minus 7 days) after extubationventilator-associated pneumonia (events)/1,000 ventilator days
Mortality ratewithin the first 30 days (plus or minus 7 days) after dischargepneumonia-specific mortality within 7 days and at discharge

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026