Does NIV-NAVA Improve Diaphragmatic Function in Preterm Infants

NCT05079412 | Completed

• 1 other identifier: 19-0324-E
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Non-Invasive Positive Pressure Ventilation (NIPPV) provides un-synchronized positive pressure and considered to be superior to nCPAP in preventing extubation failure. Recently, Non-Invasive Ventilation Neurally-Adjusted Ventilatory Assist (NIV-NAVA) was introduced to NICU. NAVA is a ventilation mode that uses the electrical activity of the patient's diaphragm (Edi-signal) to guide both timing and magnitude of the support. However, it is unknown whether NIV-NAVA is superior to NIPPV in preventing extubation failure and preventing BPD. Hence, the investigators aim to compare the effect of NIPPV and NIV-NAVA on diaphragm function in premature infants with RDS or evolving BPD. Our hypothesis is that infants treated with NIV-NAVA will have improved diaphragmatic function and lung scoring.

Conditions

Respiratory Disease

Keywords

preterm; neonates; Ultrasound; non-invasive; ventilation; Diaphragm; Lung; NIV-NAVA; NIPPV

Outcome Measures

Primary Outcomes (2)

• Evaluation of the diaphragmatic Thickness (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV)

  Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. diaphragmatic Thickness (in millimetre) will be measured. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.

  1 YEAR

• Evaluation of the diaphragmatic excursion (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV)

  Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. diaphragmatic Excursion (in millimetre) will be measured. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.

  1 YEAR

Secondary Outcomes (1)

• Lung ultrasound score for infants in NIV-NAVA group vs NIPPV group

  1 YEAR

Study Arms (2)

NIV-NAVA group

Premature infants (22 0/7 to 29 6/7 weeks gestation) with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported by NIV-NAVA for at least 24 hours are enrolled in this arm after obtaining parents' consent.

Other: Chest ultrasound

NIPPV group

Premature infants (22 0/7 to 29 6/7 weeks gestation) with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported by NIPPV for at least 24 hours are enrolled in this arm after obtaining parents' consent.

Other: Chest ultrasound

Interventions

Chest ultrasound OTHER

Chest ultrasound will be performed to eligiable (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. Both diaphragmatic function and lung ultrasound score will performed. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.

NIPPV group; NIV-NAVA group

Eligibility Criteria

• Age: 2 Weeks - 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants that were born between 22 0/7 to 29 6/7 weeks gestation and were admitted to the NICU at Mount Sinai Health System will be eligible for the study. Infants will be enrolled after obtaining parents' consent and Research Ethics Board approval

You may qualify if:

• Infants that were born at 22 0/7 to 29 6/7 weeks gestation and admitted to the NICU at Mount Sinai Health System.
• Infants that are on NIPPV or NIV-NAVA respiratory support for at least 24 hours at the time of enrolment.

You may not qualify if:

• Infants with congenital anomalies.
• Infants with known genetic disorder.
• Infants with known lung malformation or diaphragm dysfunction.
• Infants of whom parents declined consent.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• Elkhouli M, Tamir-Hostovsky L, Ibrahim J, Nasef N, Mohamed A. Ultrasonographic assessment of diaphragmatic function in preterm infants on non-invasive neurally adjusted ventilatory assist (NIV-NAVA) compared to nasal intermittent positive-pressure ventilation (NIPPV): a prospective observational study. Eur J Pediatr. 2023 Feb;182(2):731-739. doi: 10.1007/s00431-022-04738-8. Epub 2022 Dec 2.

  PMID: 36459227 DERIVED

MeSH Terms

Conditions

Respiration Disorders; Premature Birth; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adel Mohamed, MD

  Mount Sinai Hospital- Toronto, ON, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 15, 2021
• Study Start: February 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

CA (1)