Breathing Patterns in Infants Before and After Extubation

NCT07542301 | Recruiting

• 1 other identifier: DDD605736
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Distress Syndrome (RDS); PreTerm Neonate

Keywords

preterm infants; intubated; respiratory distress; extubation; work of breathing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ability of work of breathing indices to predict extubation failure.

  25 minutes

Study Arms (1)

Preterm infants who are intubated

There is only one cohort for this study and it includes preterm infants who are intubated.

Other: Observation

Interventions

Observation OTHER

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.

Preterm infants who are intubated

Eligibility Criteria

• Age: 0 Days - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

ChristianaCare Health Services, Inc.

Newark, Delaware, 19718, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Dyspnea

Interventions

Observation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Kelley Z Kovatis, MD

  Christiana Care Health Services, Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelley Z. Kovatis, MD

CONTACT

302-301-2410; kelley.kovatis@christianacare.org

Amy B Mackley

CONTACT

MSN, RNC, CCRC; amackley@christianacare.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 14, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)