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NCT Number: NCT06535074

Lung Function Monitoring During Hypoxemia Episodes

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.

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Key information

Conditions

Hypoxemia of Newborn

Sex eligibility

All sexes

Study type

Observational

Primary location

Bristol Myers Squibbs Childrens Hospital

New Brunswick, New Jersey, 08901, United States

Location status: Recruiting

Location contact

Deepak Jain, MD

CONTACT

About this study

This is an observational study evaluating changes in lung volume during hypoxemia episodes (HEs or desaturation episodes) in spontaneously breathing very preterm infants. We postulate that HEs can be differentiated into distinct subtypes based on alterations in lung volume. Additionally, the severity and duration of HEs correlates with the degree of changes in lung volumes. Therefore, we are performing an observational study in very preterm infants with spontaneous HEs and classifying these episodes into different subtypes of Apnea, forced exhalation, mixed, and unclassified subtypes according to changes in lung volume. Lung volume will be measured non-invasively using electrical impedance tomography (EIT) device (Sentec Inc, RI, USA). In brief, the device consists of a soft belt with 32 embedded electrodes which is placed around the chest of the infant and applies a weak alternating current and measures returning voltage. The measured returning voltage is dependent on the electrical conductivity of the underlying tissue. The reconstruction algorithm creates an image of regional impedance distribution in real time. These data are then used to compute lung volume parameters at different phases of respiratory cycle providing end expiratory lung impedance reflective of EELV, tidal impedance reflective of tidal volume, and regional distribution of ventilation. The changes in lung volume parameters will be used to differentiate HEs into different subtypes and correlated with degree and severity of HEs. In addition, we will also measure cerebral tissue oxygen saturation (CrSO2) to monitor changes in tissue oxygenation with hypoxemia episodes and changes in lung volume.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born at ≤32w GA
  • Post menstrual age between 30w to 36w
  • 4 or more episodes of HEs in the previous 24h (Defined as SpO2<90≥5s)

Exclusion criteria

  • Major congenital malformation
  • Receiving invasive mechanical ventilation
  • Severe neurological injury
  • Hemodynamic instability requiring inotropes in last 72h

Treatment and study plan

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.

Primary outcomes

  1. Frequency of hypoxemia episodes of each subtype

    Time frame: 6 hour

    Hypoxemia episodes classified into 4 subtypes of Apnea, forced exhalation, mixed and unclassified according to changes in lung volume parameters.

Secondary outcomes

  1. Frequency of each subtype of episode with severe hypoxemia, prolonged episode, bradycardia

    Time frame: 6hr

    Severe HEs defined as SpO2<80, Prolonged HEs duration>=30s, Bradycardia HR<100 for >=5s

  2. Number of episodes of forced exhalation, apnea not meeting the criteria for hypoxemia episodes

    Time frame: 6hr

    Episodes meeting the EIT criteria for FE and apnea but not associated with HEs

  3. Mean highest change in CrSO2 and cFToE during HEs and each subtype

    Time frame: 6hr

    Change in CrSO2 from baseline and fTOE during HEs

Study contacts

Contact information is provided by the study sponsor or research team.

Deepak Jain, MD

CONTACT

[email protected]

7322353377

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Differentiating Pathophysiological Mechanisms of Hypoxemia Episodes by Continuous Lung Function Monitoring in Preterm Infants

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 2, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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