Non-invasive Neurally Adjusted Ventilator Assist or Continuous Positive Airway Pressure in Preterm Infants

NCT04333563 | Completed DMC

• 1 other identifier: 58386
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Strategies to prevent lung injury, facilitate lung development, and to support the preterm infant's capacity to breathe are decisive. Continuous positive airway pressure (CPAP) is the gold standard in non-invasive breathing support in preterm infants with a positive pressure that keeps the alveoli slightly inflated during expiration. Non-invasive neurally adjusted ventilator assist (NIV NAVA) is a novel method of breathing support and uses the electrical activity from the diaphragm to trigger the ventilator and synchronize with the breathing cycle. During NIV NAVA the preterm infant controls the onset of the inspiration, the respiratory rate, inspiratory time and peak pressure. This method has the potential to improve the positive pressure transmission to the infant's lower airways, accurate synchronization with the breathing pattern and be a comfortable breathing support system for the preterm infant. The investigators will compare the effect on breathing effort in preterm infants during continuous positive airway pressure and non-invasive neurally adjusted ventilatory assist measured by electrical activity in the diaphragm, respiratory vital signs, systematic clinical scoring of breathing effort and comfort, and parent reported outcomes.

Conditions

Premature Birth; Respiratory Distress Syndrome, Newborn

Keywords

Infants, preterm; Respiration, Artificial; Diaphragm; Intensive Care Units, Neonatal; Continuous Positive Airway Pressure; Non invasive neurally adjusted ventilator assist

Outcome Measures

Primary Outcomes (1)

• Electrical activity of the diaphragm

  Electromyography signals from the diaphragm in 30 second intervals

  9 hours and 30 minutes

Secondary Outcomes (8)

• Silverman Andersen Respiratory Severity Score

  Three minutes

• Scoring blinded for the intervention

  Three minutes video-recording

• COMFORTneo pain scale

  Three minutes

• Parents opinion about the outcomes

  Three minutes

• Respiratory rate

  30 second intervals

Study Arms (2)

CPAP

ACTIVE COMPARATOR

respiratory stressed infants getting Continuous positive airway pressure (CPAP)

Device: CPAP; Device: NIV NAVA

respiratory stressed infants getting NIV NAVA

EXPERIMENTAL

respiratory stressed infants getting Non-invasive neurally adjusted ventilatory assist (NIV NAVA)

Device: CPAP; Device: NIV NAVA

Interventions

CPAP DEVICE

Continuous positive airway pressure

CPAP; respiratory stressed infants getting NIV NAVA

NIV NAVA DEVICE

Non-invasive neurally adjusted ventilatory assist

CPAP; respiratory stressed infants getting NIV NAVA

Eligibility Criteria

• Age: 24 Hours - 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• spontaneously breathing preterm infants 24 to 96 hours old
• gestational age (GA) between week 28+0 and 31+6
• preterm infants with GA \< 28+0 with a postmenstrual age (PMA) \> 28 weeks
• at least 72 hours old treated with CPAP or NIV NAVA

You may not qualify if:

• preterm infants with severe congenital malformation
• need for vasopressors
• preterm children in need of a specific respiratory support system due to medical reasons

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Department of Pediatrics St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome, Newborn; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; 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

• Elisabeth Selvaag, md

  St Olavs Hospital, Barne- og ungdomsklinikk

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: April 14, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2022 and to 2027

Locations

NO (1)