Breathing Patterns in Infants Before and After Extubation

The primary objective of this study is to compare work of breathing indices before and after extubation in intubated premature infants admitted to the Christiana Care Neonatal Intensive Care Unit. The secondary objective is to compare the ability of work of breathing indices to predict extubation failure to routine spontaneous breathing tests (SBTs) in intubated premature infants admitted to the ChristianaCare NICU.

Study Overview

• Status: Recruiting
• Conditions: PreTerm Neonate; Respiratory Distress Syndrome (RDS)
• Intervention / Treatment: Other: Observation

Detailed Description

For clinicians, the ability to accurately predict which infants will successfully extubate is essential. Doctors and nurses routinely use a combination of vital signs (heart rate, respiratory rate, oxygen saturations), physical examination and spontaneous breathing trials to determine a baby's readiness to have their breathing tube removed. A spontaneous breathing trial is routinely done in our NICU and involves reducing the support that the baby receives from the breathing machine while leaving the breathing tube in place. These methods do not always accurately predict which babies are ready to be extubated.

This prospective observational pilot study will measure work of breathing (how hard or how easy a baby breathes) before, during and after the routine spontaneous breathing test is done. The study will also measure work of breathing before and after removal of the breathing tube, if a baby's medical team decides the baby is ready to have their tube removed.

Work of breathing indices will be measured through respiratory inductive plethysmography (RIP). Soft elastic cloth bands will be placed around the baby's chest and abdomen. These bands measure how well the chest and abdomen work together when a baby breathes. We hypothesize that PneuRIP can predict extubation failure.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Kelley Z. Kovatis, MD; Phone Number: 302-301-2410; Email: kelley.kovatis@christianacare.org
• Study Contact Backup: Name: Amy B Mackley; Phone Number: MSN, RNC, CCRC; Email: amackley@christianacare.org

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Recruiting
      • ChristianaCare Health Services, Inc.
      • Contact: Amy B Mackley, MSN; Phone Number: 302-301-2153; Email: amackley@christianacare.org
      • Contact: Kelley Z. Kovatis, MD; Phone Number: 302-301-2410; Email: kelley.kovatis@christianacare.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population includes premature infants, admitted to the NICU at Christiana care and who are intubated.

Description

Inclusion Criteria:

• premature infants (born at ≤32 weeks gestation) who are intubated.
• medical team is evaluating the baby for extubation readiness

Exclusion Criteria:

• Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of RIP measurements will be excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm infants who are intubated; There is only one cohort for this study and it includes preterm infants who are intubated.	Other: Observation; Infants work of breathing will be observed through placement of soft elastic cloth bands on the infant's chest and abdomen. These bands measure how well the chest and abdomen work together when a baby breathes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work of breathing before and after extubation	The primary objective of this study is to compare work of breathing indices before and after extubation in intubated premature infants admitted to the Christiana Care Neonatal Intensive Care Unit. We will observe work of breathing for 5-10 minutes before the infant is extubated and 5-10 minutes after the infant is extubated.	25 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of work of breathing indices to predict extubation failure.	The secondary objective is to compare the ability of work of breathing indices to predict extubation failure to routine spontaneous breathing tests (SBTs) in intubated premature infants admitted to the ChristianaCare NICU. We will record a baby's work of breathing measurements for 5-10 minutes before the routine spontaneous breathing test, up to 5 minutes during the spontaneous breathing test, and for 5-10 minutes after the spontaneous breathing test.	25 minutes

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Investigators: Principal Investigator: Kelley Z Kovatis, MD, Christiana Care Health Services, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: respiratory distress; preterm infants; intubated; extubation; work of breathing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiratory Distress Syndrome; Dyspnea; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: DDD605736

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No