Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive Ventilation

NCT03422549 | Unknown DMC

• 1 other identifier: H17-02003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (CPAP) is one of the most commonly used tools but does not always provide enough support. A new option is non-invasive high frequency ventilation (NHFOV), which gently shakes the lungs to help with gas exchange and may decrease a baby's work of breathing. The investigators plan to study very low birth weight preterm babies who are generally well but require some support with their breathing. By inserting a special feeding tube with sensors into the stomach, the investigators can measure the electrical activity of the diaphragm (EAdi), which is an important muscle for breathing. By analyzing EAdi in babies receiving either CPAP or NHFOV, the investigators will be able to measure and compare how each method of support affects a baby's breathing. This important study will help us determine the most appropriate breathing support for preterm babies.

Conditions

Respiratory Distress Syndrome, Newborn; Chronic Lung Disease of Newborn (Diagnosis)

Keywords

diaphragm; non-invasive ventilation; high-frequency oscillation; CPAP

Outcome Measures

Primary Outcomes (1)

• The difference in the peak electrical activity of the diaphragm between CPAP and NHFOV.

  Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).

  4 hours

Secondary Outcomes (6)

• Difference in neural respiratory rate.

  4 hours

• Difference in neural inspiratory time.

  4 hours

• Difference in diaphragm energy expenditure.

  4 hours

• Difference in transcutaneous pCO2 on the different modes of non-invasive ventilation.

  4 hours

• Difference in the number of apnea episodes.

  4 hours

Study Arms (2)

CPAP

ACTIVE COMPARATOR

Nasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants. Intervention: Device: Drager VN500 Ventilator

Device: Drager VN500 Ventilator

NHFOV

ACTIVE COMPARATOR

Non-invasive high-frequency ventilation is a relatively new modality that is being utilized to support preterm infants and prevent the need for invasive ventilation, but this particular modality has not been well studied to date. Intervention: Device: Drager VN500 Ventilator

Device: Drager VN500 Ventilator

Interventions

Drager VN500 Ventilator DEVICE

This ventilator is capable of providing both CPAP and NHFOV support.

CPAP; NHFOV

Eligibility Criteria

• Age: 48 Hours - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinically stable preterm infants with birth weights ≤1500g admitted to the neonatal intensive care unit (NICU) at the Children's and Women's Hospital of BC
• On nasal continuous positive airway pressure of 6 to 8 cmH20 support for at least 48 hours, treated with methylxanthines for apnea of prematurity and requiring 21-40% of oxygen.

You may not qualify if:

• infants with congenital anomalies of the gastrointestinal tract, phrenic nerve damage, diaphragmatic paralysis, esophageal perforation.
• infants with congenital or acquired neurological deficit (including significant intraventricular hemorrhage \>Grade II), neonatal seizure.
• infants with significant congenital heart disease (including symptomatic PDA).
• infants with congenital anomalies of the diaphragm.
• infants with congenital anomalies of the respiratory tracts (e.g. Congenital Cystic Adenomatoid Malformation (CCAM)).
• infants requiring ongoing treatment for sepsis, necrotizing enterocolitis (NEC), antibiotics for lung infections, narcotic analgesics, or gastric motility agents.
• infants on nasal CPAP and requiring more than 40% oxygen
• infants with significant gastric residuals and vomiting.
• infants with facial anomalies.
• infants with pneumothorax or pneumomediastinum.
• infants in the immediate postoperative period.

Sponsors & Collaborators

• University of British Columbia: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

British Columbia Women's Hospital and Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Disease

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Wong, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Wong, MD

CONTACT

604-875-2345; jonathan.wong@cw.bc.ca

Jennifer Claydon

CONTACT

604-875-2345; jclaydon@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist, Clinical Assistant Professor

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: July 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: February 1, 2020
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

CA (1)