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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome

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

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medcial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Neetu Singh, MD, MPH, Dartmouth-Hitchcock Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Estimate): March 11, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; RDS; Preterm; Extubation failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: D14057