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Recruiting NCT07542301

Breathing Patterns in Infants Before and After Extubation

Conditions: Respiratory Distress Syndrome (RDS) PreTerm Neonate

Sponsor: Christiana Care Health Services

trial.available_in: БГ
Overview
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.
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.
Who can participate
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.
Interventions
Observation
OTHER
Locations 1
United States (1)
ChristianaCare Health Services, Inc.
Newark , Delaware
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
0 Days
Maximum age
6 Months
Healthy volunteers
No
Start date
14.04.2025
Completion date
01.12.2026
Registry ID
NCT07542301
Source
clinicaltrials.gov
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