Clinical trial NCT02144363: Electrical Activity of Diaphragm as a Means to Predict Extubation Success in Preterm Infants
Official title: A Prospective Study of Diaphragmatic Electrical Activity in Preterm Infants as a Means to Predict Extubation Success
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome
Keywords: Preterm
RDS
Mechanical Ventilation
Extubation failure
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of forty(40) preterm infants less than 35 week gestation admitted in the ICN with the need for intubation and mechanical ventilation for respiratory distress in the first 24 hours of life will be recruited for this study.

Brief 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

Eligibility criteria: Inclusion Criteria:

Preterm infants less than 35 week gestation, requiring intubation and mechanical ventilation for respiratory distress in the first 24 hours of life

Exclusion Criteria:

Infants with a non-intact esophagus (e.g tracheal-esophageal fistula or atresia), a non-functional diaphragm (e.g. phrenic nerve palsy), severe intracranial hemorrhage or structural CNS abnormality, severe birth asphyxia and critically sick infant needing paralysis or deep sedation.

Primary outcomes:
measure: Edi_avg just prior to extubation in infants with extubation success and those with extubation failure
timeFrame: From time of initial intubation to 3 days after extubation from mechanical ventilator
Secondary outcomes:
measure: Study the trends of Edi_avg in preterm infants with respiratory distress syndrome requiring mechanical ventilation in first seven days of life.
timeFrame: First seven days of life
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medcial Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Neetu Singh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh N, McNally MJ, Darnall RA. Does Diaphragmatic Electrical Activity in Preterm Infants Predict Extubation Success? Respir Care. 2018 Feb;63(2):203-207. doi: 10.4187/respcare.05539. Epub 2017 Nov 28.