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NCT Number: NCT04333563

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

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.

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Key information

Conditions

Premature Birth Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Respiration Disorders Respiratory Aspiration Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Urogenital Diseases

Age range

24 hour–96 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatrics St Olavs Hospital

Trondheim, Norway

About this study

This is a randomized cross-over study with AB/BA sequences. The infants will receive both interventions in 4 hours intervals, a 30 minutes period to change the breathing support and a 30 minutes wash out period between interventions. Initially positive end expiratory pressure are set to 5 cm H2O and can be adjusted up to 7 cm H2O if needed decided by the medical team for both interventions. The neurally adjusted level will be set to obtain average Edi peak < 15 microvolt. Back-up setting and apnea time in the ventilator assist intervention (NIV NAVA) will be individualized according to clinical parameters in each preterm infant.

Modification approved by ethical committee REK 2021, 6th of August:

After two hours in each intervention, the nurse responsible for the infant will perform the clinical scoring. In addition it will be investigated if there is a difference in respiratory vital signs during skin to skin care and in the incubator. During each intervention period, the preterm infants are placed on the parent's chest skin to skin for at least one hour.

A modified version of the scoring tool will be used, i.e. without the item of nasal flaring and expiratory grunting. The headgear for CPAP and NIV NAVA covers parts of the nose and makes nasal flaring difficult to observe.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

CPAP

Device

Continuous positive airway pressure

NIV NAVA

Device

Non-invasive neurally adjusted ventilatory assist

Primary outcomes

  1. Electrical activity of the diaphragm

    Time frame: 9 hours and 30 minutes

    Electromyography signals from the diaphragm in 30 second intervals

Secondary outcomes

  1. Silverman Andersen Respiratory Severity Score

    Time frame: Three minutes

    The scoring tool consists of 5 categories and respiratory distress are graded from zero to two for each category. Respiratory distress gets worse the higher the total score gets.

  2. Scoring blinded for the intervention

    Time frame: Three minutes video-recording

    During each intervention, the infants will be video recorded for a blinded assessment.

  3. COMFORTneo pain scale

    Time frame: Three minutes

    Measuring pain and discomfort in a seven category scale graded from 1 - 5, where one is best and five is worse.

  4. Parents opinion about the outcomes

    Time frame: Three minutes

    Three questions about their opinion about the interventions in a 5 point Likert scale

  5. Respiratory rate

    Time frame: 30 second intervals

    Standard monitoring on IntelliVue monitor

  6. Heart rate

    Time frame: 30 second intervals

    Standard monitoring on IntelliVue monitor

  7. Oxygen saturation

    Time frame: 30 second intervals

    Standard monitoring on IntelliVue monitor

  8. number of apneic episodes ≥ 20 seconds

    Time frame: 9 hours and 30 seconds

    Using trend function on the IntelliVue monitor

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

Non-invasive Neurally Adjusted Ventilator Assist or Continuous Positive Airway Pressure in Preterm Infants: A Randomized Crossover Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 3, 2020
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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