Trials / Completed
CompletedNCT02144363
Electrical Activity of Diaphragm as a Means to Predict Extubation Success in Preterm Infants
A Prospective Study of Diaphragmatic Electrical Activity in Preterm Infants as a Means to Predict Extubation Success
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 21 (actual)
- Sponsor
- Dartmouth-Hitchcock Medical Center · Academic / Other
- Sex
- All
- Age
- 1 Hour – 28 Days
- Healthy volunteers
- Not accepted
Summary
Mechanical ventilation used to support the sick newborn infant is associated with many complications including the development of chronic lung disease. Limiting prolonged invasive ventilation remains an important strategy to decrease lung injury and prevent chronic lung disease. Currently, there is no objective measure available to predict readiness for removal of the endotracheal tube ("extubation") and discontinuing mechanical ventilation in this fragile population. The investigators propose to predict extubation success by evaluating the electrical activity of the diaphragm (Edi), which provides important information about the "drive" to breathing coming from the brain and the function of the diaphragm, two essential factors determining extubation readiness and success.
Detailed description
In this observational study, very low birth weight preterm infants with RDS who require mechanical ventilation in first 24 hour of life will be recruited. A size appropriate nasogastric tube with multiple array of electrodes (Edi catheter) will be inserted in each eligible infant. The average EdI (Edi\_avg) will be measured during mechanical ventilation just before extubation. All infants will be extubated to non-invasive positive pressure ventilation (NIPPV or CPAP) delivered through nasal cannula The specific aim is to determine whether there is a relationship between Edi\_avg before extubation and the extubation success in a sample of preterm infants with respiratory distress syndrome (RDS). We hypothesize that Edi-avg of infants with successful extubation will be significantly different from the infants who fail extubation
Conditions
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2015-10-01
- Completion
- 2015-10-01
- First posted
- 2014-05-22
- Last updated
- 2016-03-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02144363. Inclusion in this directory is not an endorsement.