Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT03422549

Conditions

Respiratory Distress Syndrome, Newborn

Chronic Lung Disease of Newborn (Diagnosis)

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Drager VN500 Ventilator

Study Details

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)

Study ID

NCT03422549

Start date

Jul 1, 2018

Status verified date

Apr, 2019

Completion date

Feb 1, 2020

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CPAP

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

Intervention: Device: Drager VN500 Ventilator

active comparator: 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

Interventions

Drager VN500 Ventilator

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

Primary outcome measure

  • The difference in the peak electrical activity of the diaphragm between CPAP and NHFOV. [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Jonathan Wong, MD

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

Jennifer Claydon

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

Locations

British Columbia Women's Hospital and Health Centre

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Jonathan Wong, MD

16048752345jonathan.wong@cw.bc.ca

jonathan.wong@cw.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Apr 17, 2019

Last verified

Apr, 2019

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2019-04-17.