Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive Ventilation

NCT ID: NCT03422549

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-02-01

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.

Detailed Description

Continuous Positive Airway Pressure is one of the most researched and accepted methods of delivering NIV to term and preterm infants. Non-invasive high frequency ventilation is a relatively new method of delivering NIV respiratory support in preterm infants. Preliminary studies suggest superiority over CPAP, and NHFOV is being increasingly utilized in clinical practice in an attempt to prevent intubation and minimize ventilation-induced lung injury in preterm infants. However, little is known about its mechanism of action and its effect on respiratory mechanics in the newborn. The objective of this study is to compare the effects of non-invasive ventilation (NIV) delivered by nasal Continuous Positive Airway Pressure (CPAP) versus Non-Invasive High Frequency Ventilation (NHFOV) on respiratory pattern as assessed by the electrical activity of the diaphragm (EAdi) in very low birth weight (VLBW) preterm infants.

The investigators hypothesize that in VLBW preterm infants with relative pulmonary insufficiency, NHFOV will reduce respiratory drive and improve ventilation, subsequently resulting in decreased patient diaphragm energy expenditure. This would be demonstrated by decreased neural respiratory rates and/or decreased peak electrical activity of the diaphragm while breathing on NHFOV compared to CPAP.

Clinicians are seeking alternative methods for providing non-invasive respiratory support to preterm infants. NHFOV is a relatively new modality that is being increasingly utilized in clinical practice but has not been well studied. This study will help the investigators determine how non-invasive high frequency ventilation affects breathing in preterm infants, as compared to the more traditional modality of nasal CPAP. Therefore, clinicians will not only be able to better understand how NHFOV works, but also utilize this information to decide on the most appropriate respiratory support modality for preterm patients

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP

Nasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants.

Intervention: Device: Drager VN500 Ventilator

Group Type: ACTIVE_COMPARATOR

Drager VN500 Ventilator

Intervention Type: DEVICE

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

NHFOV

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

Group Type: ACTIVE_COMPARATOR

Drager VN500 Ventilator

Intervention Type: DEVICE

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

Interventions

Drager VN500 Ventilator

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 48 Hours
• Maximum Eligible Age: 90 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Wong

Neonatologist, Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Wong, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

British Columbia Women's Hospital and Health Centre

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jonathan Wong, MD

Role: CONTACT

jonathan.wong@cw.bc.ca

604-875-2345 ext. 7348

Jennifer Claydon

Role: CONTACT

jclaydon@cw.bc.ca

604-875-2345 ext. 7408

Facility Contacts

Jonathan Wong, MD

Role: primary

jonathan.wong@cw.bc.ca

16048752345 ext. 7344

Role: backup

jonathan.wong@cw.bc.ca

Other Identifiers

H17-02003

Identifier Type: -

Identifier Source: org_study_id