Clinical Trials Directory

Trials / Terminated

TerminatedNCT02326207

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
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Prince of Songkla University · Academic / Other
Sex
All
Age
1 Day – 1 Year
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEInfant Ventilator Circuit Dual Heated with Autofeed Chamber

Timeline

Start date
2015-04-01
Primary completion
2017-03-01
Completion
2017-03-01
First posted
2014-12-25
Last updated
2023-06-13

Locations

1 site across 1 country: Thailand

Source: ClinicalTrials.gov record NCT02326207. Inclusion in this directory is not an endorsement.