Breathing patterns in preterm infants before and after extubation.
Official title: Breathing Patterns in Infants Before and After Extubation
Run by Christiana Care Health Services · NCT07542301 · Data updated 2026-11-12
This will try to see if measuring work of breathing with soft chest and abdominal bands can predict which intubated premature infants (≤32 weeks) will tolerate removal of their breathing tube.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 6 Months |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Christiana Care Health Services Academic / other |
| Locations | 1 site (Newark, Delaware) |
| Status | Recruiting |
| Started | April 14, 2025 |
| Main results expected | October 2026 |
| Study ends | December 2026 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07542301 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Intubated premature infants born at ≤32 weeks gestation who are being evaluated for extubation readiness are the ideal candidates.
✕Probably not a fit
Infants with skeletal, neuromuscular, or abdominal surgical conditions that interfere with RIP measurements, or infants not being considered for extubation, are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational pilot measures work of breathing in intubated premature infants before, during, and after routine spontaneous breathing trials and after extubation if performed. Soft elastic respiratory inductive plethysmography (RIP) bands placed around the chest and abdomen will record chest and abdominal motion and derived work-of-breathing indices. The study compares these RIP-derived indices to routine clinical measures and spontaneous breathing trial results to see whether RIP predicts extubation failure. Infants born at ≤32 weeks gestation undergoing extubation evaluation in the ChristianaCare NICU are eligible, with exclusions for conditions that affect RIP accuracy.
Why it matters
Potential benefit: If successful, RIP-derived work-of-breathing measurements could help clinicians better predict extubation readiness, reducing failed extubations and unnecessary prolonged intubation.
How similar studies have gone: Similar pilot studies using respiratory inductive plethysmography and other work-of-breathing measures have shown promise in small cohorts, but larger validation in preterm extubation decisions is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
ChristianaCare Health Services, Inc.
Newark, Delaware, United States Recruiting
Study contacts
- Principal investigator: Kelley Z Kovatis, MD — Christiana Care Health Services, Inc
- Study coordinator: Kelley Z. Kovatis, MD
- Email: kelley.kovatis@christianacare.org
- Phone: 302-301-2410
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.