Electrical Activity of Diaphragm as a Means to Predict Extubation Success in Preterm Infants

Respiratory Distress Syndrome Clinical Trial

— Edi  

Official title:

A Prospective Study of Diaphragmatic Electrical Activity in Preterm Infants as a Means to Predict Extubation Success

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144363
• Other study ID #: D14057
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: March 10, 2016
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medcial Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edi_avg just prior to extubation in infants with extubation success and those with extubation failure	Edi_avg prior to extubation will be compared between the group with successful extubation and those with failed extubation( i.e.needing re-intubation within 3 days of extubation)	From time of initial intubation to 3 days after extubation from mechanical ventilator	No
Secondary	Study the trends of Edi_avg in preterm infants with respiratory distress syndrome requiring mechanical ventilation in first seven days of life.	Edi_avg will be recorded continuously during mechanical ventilation to a maximum of seven day. We hypothesize that Edi_avg would correlate with severity of respiratory distress ( measured by respiratory severity index, FiO2 X Mean airway pressure)	First seven days of life	No