Breathing patterns in preterm infants before and after extubation.
Breathing Patterns in Infants Before and After Extubation
Christiana Care Health Services · NCT07542301
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 0 Days to 6 Months |
| Sex | All |
| Sponsor | Christiana Care Health Services (other) |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT07542301 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Intubated premature infants born at ≤32 weeks gestation who are being evaluated for extubation readiness are the ideal candidates.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Newark, Delaware
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Distress Syndrome, PreTerm Neonate, preterm infants, intubated, respiratory distress, extubation, work of breathing