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

NCT02144363 | Completed DMC

• 1 other identifier: D14057
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome

Keywords

Preterm; RDS; Mechanical Ventilation; Extubation failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medcial Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• 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.

  PMID: 29184049 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Neetu Singh, MD, MPH

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 22, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 11, 2016

Record last verified: 2016-03

Locations

US (1)