Recruiting

Observational Study

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06535074

Conditions

Hypoxemia of Newborn

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Detecting changes in lung volume with hypoxemia episodes

Study Details

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

Study ID

NCT06535074

Start date

Apr 4, 2024

Status verified date

May, 2026

Completion date

Aug 4, 2027

Anticipated

Primary completion date

Aug 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Arms

Preterm infants with hypoxemia episodes

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

Interventions

Detecting changes in lung volume with hypoxemia episodes

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 outcome measure

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

Central Contacts and Locations

Central contacts

Deepak Jain, MD

7322353377dj392@rwjms.rutgers.edu

Locations

Bristol Myers Squibbs Childrens Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • electrical impedance tomography
  • hypoxemia episodes
  • lung volume

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-05-15.