Clinical trial NCT06535074: Lung Function Monitoring During Hypoxemia Episodes
Official title: Differentiating Pathophysiological Mechanisms of Hypoxemia Episodes by Continuous Lung Function Monitoring in Preterm Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypoxemia of Newborn
Keywords: electrical impedance tomography
hypoxemia episodes
lung volume
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants admitted to the neonatal intensive care unit at Bristol Myers Squibb Children's Hospital and meeting eligibility criteria will be considered for enrollment and parents will be approached for informed consent.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of hypoxemia episodes of each subtype
timeFrame: 6 hour
Secondary outcomes:
measure: Frequency of each subtype of episode with severe hypoxemia, prolonged episode, bradycardia
timeFrame: 6hr
measure: Number of episodes of forced exhalation, apnea not meeting the criteria for hypoxemia episodes
timeFrame: 6hr
measure: Mean highest change in CrSO2 and cFToE during HEs and each subtype
timeFrame: 6hr
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Bristol Myers Squibbs Childrens Hospital
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School Department of Pediatrics
name: Deepak Jain, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bancalari E, Claure N. Respiratory Instability and Hypoxemia Episodes in Preterm Infants. Am J Perinatol. 2018 May;35(6):534-536. doi: 10.1055/s-0038-1637760. Epub 2018 Apr 25.
citation: Bolivar JM, Gerhardt T, Gonzalez A, Hummler H, Claure N, Everett R, Bancalari E. Mechanisms for episodes of hypoxemia in preterm infants undergoing mechanical ventilation. J Pediatr. 1995 Nov;127(5):767-73. doi: 10.1016/s0022-3476(95)70171-0.
citation: Esquer C, Claure N, D'Ugard C, Wada Y, Bancalari E. Role of abdominal muscles activity on duration and severity of hypoxemia episodes in mechanically ventilated preterm infants. Neonatology. 2007;92(3):182-6. doi: 10.1159/000102056. Epub 2007 Apr 27.
citation: van der Burg PS, Miedema M, de Jongh FH, Frerichs I, van Kaam AH. Cross-sectional changes in lung volume measured by electrical impedance tomography are representative for the whole lung in ventilated preterm infants. Crit Care Med. 2014 Jun;42(6):1524-30. doi: 10.1097/CCM.0000000000000230.
citation: Piraino T. An Introduction to the Clinical Application and Interpretation of Electrical Impedance Tomography. Respir Care. 2022 Jun;67(6):721-729. doi: 10.4187/respcare.09949.