Recruiting

Observational Study

Sponsor:

Christiana Care Health Services

Code:

NCT07542301

Conditions

Respiratory Distress Syndrome (RDS)

PreTerm Neonate

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Observation

Study Details

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

Study ID

NCT07542301

Start date

Apr 14, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Preterm infants who are intubated

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

Interventions

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.

Primary outcome measure

  • Work of breathing before and after extubation [ Time Frame: 25 minutes ]

Central Contacts and Locations

Central contacts

Kelley Z. Kovatis, MD

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

Amy B Mackley

MSN, RNC, CCRCamackley@christianacare.org

Locations

ChristianaCare Health Services, Inc.

Recruiting

Newark, Delaware, United States, 19718

Contacts

Kelley Z. Kovatis, MD

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

Amy B Mackley, MSN

302-301-2153amackley@christianacare.org

More Information

Sponsor

Christiana Care Health Services

Last update posted

Apr 21, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Christiana Care Health Services on 2026-04-21.