CClinicalTrials.gg
TerminatedNCT02326207Updated Jun 13, 2023

Weekly Versus no Routine Ventilator Circuit Changes in NICU

An interventional study of Infant Ventilator Circuit Dual Heated with Autofeed Chamber in Pneumonia, Ventilator-Associated, sponsored by Prince of Songkla University. Terminated at 1 site in Thailand. Open to participants aged 1 Day to 1 Year. Per ClinicalTrials.gov, last updated 2023-06-13.

Sponsored by Prince of Songkla University · Not applicable, Interventional, and Health services research

Why this study was terminated
very low enrolled participants
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
1 Day to 1 Year
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Pneumonia, Ventilator-Associated

Keywords

  • Infant, Newborn
  • Neonatal intensive care unit
  • Ventilator circuit
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In context

Pneumonia, Ventilator-Associated

392 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 81 are open to participants now.

This study's enrollment of 19 is below the median of 122 across 254 interventional studies indexed under Pneumonia, Ventilator-Associated.

Browse Pneumonia, Ventilator-Associated studies →

Lead sponsor

Prince of Songkla University is the lead sponsor of 112 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 1 Year
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Weekly ventilator circuit change

    Ventilator circuit change every 7 days until extubation

    Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber

  • Active comparator
    No routine ventilator circuit change

    No routine ventilator circuit change until soiling or malfunction or extubation

    Device: Infant Ventilator Circuit Dual Heated with Autofeed Chamber

Interventions

  • DeviceInfant Ventilator Circuit Dual Heated with Autofeed Chamber

    Also known as: Evaqua2, RT265

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What researchers measure

Primary outcomes

  1. incidence of ventilator-associated pneumonia (percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant)

    percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant

    Time frame: within the first 30 days (plus or minus 7 days) after extubation

Secondary outcomes

  1. incidence of ventilator-associated pneumonia (ventilator-associated pneumonia (events)/1,000 ventilator days)

    ventilator-associated pneumonia (events)/1,000 ventilator days

    Time frame: within the first 30 days (plus or minus 7 days) after extubation

  2. Mortality rate

    pneumonia-specific mortality within 7 days and at discharge

    Time frame: within the first 30 days (plus or minus 7 days) after discharge

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Study locations

1 site
  • Songklanagarind Hospital, Prince of Songkla University
    Hat-Yai, Songkhla 90110, Thailand
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References and documents

Publications

  • Cernada M, Aguar M, Brugada M, Gutierrez A, Lopez JL, Castell M, Vento M. Ventilator-associated pneumonia in newborn infants diagnosed with an invasive bronchoalveolar lavage technique: a prospective observational study. Pediatr Crit Care Med. 2013 Jan;14(1):55-61. doi: 10.1097/PCC.0b013e318253ca31. PubMed 22791095 ↗
  • Apisarnthanarak A, Holzmann-Pazgal G, Hamvas A, Olsen MA, Fraser VJ. Ventilator-associated pneumonia in extremely preterm neonates in a neonatal intensive care unit: characteristics, risk factors, and outcomes. Pediatrics. 2003 Dec;112(6 Pt 1):1283-9. doi: 10.1542/peds.112.6.1283. PubMed 14654598 ↗
  • Afjeh SA, Sabzehei MK, Karimi A, Shiva F, Shamshiri AR. Surveillance of ventilator-associated pneumonia in a neonatal intensive care unit: characteristics, risk factors, and outcome. Arch Iran Med. 2012 Sep;15(9):567-71. PubMed 22924377 ↗
  • Kawanishi F, Yoshinaga M, Morita M, Shibata Y, Yamada T, Ooi Y, Ukimura A. Risk factors for ventilator-associated pneumonia in neonatal intensive care unit patients. J Infect Chemother. 2014 Oct;20(10):627-30. doi: 10.1016/j.jiac.2014.06.006. Epub 2014 Jul 4. PubMed 25000829 ↗
  • Han J, Liu Y. Effect of ventilator circuit changes on ventilator-associated pneumonia: a systematic review and meta-analysis. Respir Care. 2010 Apr;55(4):467-74. PubMed 20406515 ↗
  • Makhoul IR, Kassis I, Berant M, Hashman N, Revach M, Sujov P. Frequency of change of ventilator circuit in premature infants: Impact on ventilator-associated pneumonia. Pediatr Crit Care Med. 2001 Apr;2(2):127-132. doi: 10.1097/00130478-200104000-00006. PubMed 12797871 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02326207
Lead sponsor
Prince of Songkla University
Responsible party
Anucha Thatrimontrichai (Mr, Prince of Songkla University) — Principal investigator
First posted
Dec 25, 2014
Start date
Apr 2015
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Jun 13, 2023

Study contacts

Anucha Thatrimontrichai, MD
principal investigator · Prince of Songkla University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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