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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02144363

Acronym

Edi

Enrollment

Registered

2014-05-22

Start date

2014-08-31

Completion date

2015-10-31

Last updated

2016-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Keywords

Preterm, RDS, Mechanical Ventilation, Extubation failure

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Hours to 28 Days

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Edi_avg just prior to extubation in infants with extubation success and those with extubation failure	From time of initial intubation to 3 days after extubation from mechanical ventilator	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)

Secondary

Measure	Time frame	Description
Study the trends of Edi_avg in preterm infants with respiratory distress syndrome requiring mechanical ventilation in first seven days of life.	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)

Countries

United States

Outcome results