Lung Function Monitoring During Hypoxemia Episodes

Conditions

• Hypoxemia of Newborn

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Detecting changes in lung volume with hypoxemia episodes — OTHER
  Electrical impedance tomography (EIT) will be used to assess changes in lung aeration prior and during hypoxemia episodes to classify them into four different subtypes. FE subtype: Defined as HEs preceded by reduction in EELI below the baseline. Apnea subtype: Defined as HEs not meeting the criteria for FE subtype and preceded by cessation of breathing. Mixed subtype: Defined as HEs meeting the criteria for both FE and apnea subtypes. Unclassified: Defined as HEs not categorized into any of the above parameters.

Study Details

Premature infants commonly have desaturation episodes due to different reasons such as cessation of breathing or loss of lung volume. The purpose of this study is to differentiate the mechanisms of desaturation episodes with continuous lung volume monitoring. As we better understand the mechanisms underlying the desaturation episodes, newer strategies directed at underlying pathophysiology can potentially by evaluated for mitigation of these episodes.

Key Dates

Start date

Apr 4, 2024

Status verified

May 2026

Primary completion

Aug 4, 2027

Completion

Aug 4, 2027

Study Design

Enrollment

35 participants (estimated)

Arms

• Arm: Preterm infants with hypoxemia episodes
  Very preterm infants with spontaneous HEs and not receiving invasive mechanical ventilation.

Primary Outcome Measure

Frequency of hypoxemia episodes of each subtype [ Time Frame: 6 hour ]

Central Contacts

• Deepak Jain, MD
  7322353377
  [email protected]

Locations (1)

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