Low and High Flow Suctioning in Intubated Infants

This study is looking at how different suctioning methods affect intubated infants (babies with a breathing tube) who are in the Neonatal Intensive Care Unit (NICU) due to respiratory failure (trouble breathing). Researchers are comparing a new, FDA-approved device called EXSALTA with the standard suctioning method used in hospitals. They want to see how these methods change your baby's heart rate, oxygen levels in the blood (SpO2), and oxygen levels in the brain (C-rSO2) up to one hour after suctioning. The study is enrolling 30 infants. To join, your baby must be a preterm (born early) or full-term infant, weigh more than 1000 grams, and be receiving endotracheal tube (ETT) suctioning. Babies with certain heart conditions are not eligible. The study status is currently unclear.

Study design
This study is an interventional study with a planned enrollment of 30 infants. It uses a randomized crossover design, meaning each infant will experience both suctioning methods in a random order.
What's involved
Your baby will undergo two sequential suctioning procedures, one with the EXSALTA device and one with the standard conventional wall suction. Heart rate, oxygen saturation, and cerebral oxygenation will be measured before and up to one hour after each suctioning.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken up to one hour after suctioning procedures.

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NCT06443970

Low and High Flow Suctioning in Intubated Infants

Recruiting
NAUp to 28InterventionalSupportive care
Columbia University
~30 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Exsalta Suction Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in heart rate (HR)
Measured over Before suctioning (baseline) and up to 1-hour after suctioning
+3 more outcomes measured
Respiratory Failure
1 sites across 1 states
New York1
  • Rakesh Sahni, MD · PRINCIPAL_INVESTIGATOR · Columbia University

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Eligibility criteria

Inclusion

Preterm and term infants with birth weight more than 1000g receiving ETT suctioning

Exclusion

Infants with cyanotic congenital heart disease and cardiac rhythm disorders (arrythmias) will be excluded from the study.
  • Change in heart rate (HR)Before suctioning (baseline) and up to 1-hour after suctioning

    Measured as beats per minute

  • Change in oxygen saturation (SpO2)Before suctioning (baseline) and up to 1-hour after suctioning

    Measured as percent (%) change

  • Change in cerebral oxygenation (C-rSO2)Before suctioning (baseline) and up to 1-hour after suctioning

    Measured as percent (%) change

  • Change in cerebral fractional oxygen extraction (c-FOE)Before suctioning (baseline) and up to 1-hour after suctioning

    Measured as difference in SpO2 and C-rSO2 (%)