Lung Function Monitoring During Hypoxemia Episodes

NCT06535074 | Recruiting

• 1 other identifier: Pro2023000655
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia of Newborn

Keywords

electrical impedance tomography; hypoxemia episodes; lung volume

Outcome Measures

Primary Outcomes (1)

• Frequency of hypoxemia episodes of each subtype

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

  6 hour

Secondary Outcomes (3)

• Frequency of each subtype of episode with severe hypoxemia, prolonged episode, bradycardia

  6hr

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

  6hr

• Mean highest change in CrSO2 and cFToE during HEs and each subtype

  6hr

Study Arms (1)

Preterm infants with hypoxemia episodes

Very preterm infants with spontaneous HEs and not receiving invasive mechanical ventilation.

Other: Detecting changes in lung volume with hypoxemia episodes

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.

Preterm infants with hypoxemia episodes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Bristol Myers Squibbs Childrens Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 29694990 BACKGROUND

• 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.

  PMID: 7472834 BACKGROUND

• 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.

  PMID: 17476118 BACKGROUND

• 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.

  PMID: 24561568 BACKGROUND

• 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.

  PMID: 35606004 BACKGROUND

Study Officials

• Deepak Jain, MD

  Rutgers Robert Wood Johnson Medical School Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepak Jain, MD

CONTACT

7322353377; dj392@rwjms.rutgers.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): August 4, 2026
• Study Completion (Estimated): August 4, 2026
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal and individual patient data meta-analysis.

Locations

US (1)