Skip to main content
OpenTrials
Completed

NCT Number: NCT03388437

Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation

Non-invasive respiratory support has been emerging in the management of respiratory distress syndrome (RDS) in preterm infants to minimise the risk of lung injury. Intermittent positive pressure ventilation (NIPPV) provides a method of augmenting continuous positive airway pressure (CPAP) by delivering ventilator breaths via nasal prongs.It may increase tidal volume, improve gas exchange and reduce work of breathing. However, NIPPV may associate with patient-ventilator asynchrony that can cause poor tolerance and risk of intubation. It may also in increased risk of pneumothorax and bowel perforation because of increase in intrathoracic pressure.

On the other hand, neurally adjusted ventilatory assist (NAVA) is a newer mode of ventilation, which has the potential to overcome these challenges. It uses the electrical activity of the diaphragm (EAdi) as a signal to synchronise the mechanical ventilatory breaths and deliver an inspiratory pressure based on this electrical activity. Comparing NI-NAVA and NIPPV in preterm infants, has shown that NI-NAVA improved the synchronization between patient and ventilator and decreased diaphragm work of breathing .

There is lack of data on the use of NI-NAVA in neonates post extubation in the literature. To date, no study has focused on short-term impacts. Therefore, it is important to evaluate the need of additional ventilatory support post extubation of NI-NAVA and NIPPV and also the risk of developing adverse outcomes.

Aim:

The aim is to compare NI-NAVA & NIPPV in terms of extubation failure in infants< 32 weeks gestation.

Hypothesis:

Investigators hypothesized that infants born prematurely < 32 weeks gestation who extubated to NI-NAVA have a lower risk of extubation failure and need of additional ventilatory support.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Study Design: Randomised controlled trial

Study Setting: single center NICU level III, KFAFH tertiary care center , Jeddah Saudi Arabia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Born less than 32 weeks gestation with respiratory distress syndrome (RDS) and requiring endotracheal tube and mechanical ventilation.
  • Less than two weeks old
  • First extubation attempt
  • CRIB score 0-5
  • Written-informed parental consent for the study

Exclusion criteria

  • Major congenital malformations or respiratory abnormalities
  • Neuromuscular disease
  • phrenic nerve palsy
  • Intraventricular hemorrhage (IVH) grade III or IV
  • Absence of informed consent
  • Out born infants

Treatment and study plan

NI-NAVA

Device

Enrolled infants will receive Surfactant and loading dose of Caffeine citrate prior to extubation. The criteria for extubation will be as per attending decision.

The device is used Servo-I ventilator (MAQUET). FiO 2 % is adjusted to maintain oxygen saturation between 90-94% on pulse oximetry. The flow rate is 8-10 L/min. NAVA electrodes will be inserted within nasogastric catheter & positioned at the level of diaphragm.Vital signs and ventilatory parameters are monitored hourly. Blood gases will be measured before and one hour after extubation

NIPPV

Device

Enrolled infants will receive Surfactant and loading dose of Caffeine citrate prior to extubation. The criteria for extubation will be as per attending decision.

The device is used Servo-I ventilator (MAQUET). FiO 2 % is adjusted to maintain oxygen saturation between 90-94% on pulse oximetry. The flow rate is 8-10 L/min. NAVA electrodes will be inserted within nasogastric catheter & positioned at the level of diaphragm.Vital signs and ventilatory parameters are monitored hourly. Blood gases will be measured before and one hour after extubation

Primary outcomes

  1. Treatment failure

    Time frame: 72 hours

    • Treatment failure during the first 72 hours post-extubation.
    • Reintubation (failure of extubation) within 72 hours' post extubation.

    Treatment failure is defined as:

    • Hypoxia (FiO 2 requirement > 0.35)
    • Respiratory acidosis defined as pH < 7.2 & PCo2> 60 mmHg
    • Major apnea requiring mask ventilation or > 4 episodes/ hour.

    The protocol will discontinue according to treatment failure criteria as mentioned above.

    Rescue treatment with NIPPV will be allowed and will be considered as treatment failure

Secondary outcomes

  1. Death prior to discharge

    Time frame: 90 days from birth

    Death

  2. Intraventricular haemorrhage IVH (grades III & IV)

    Time frame: 7 days after extubation

    defined as haemorrhage causing ventricular dilatation with or without brain parenchymal involvement

  3. Pneumothorax

    Time frame: 7 days after extubation

    diagnosed radiologically

  4. Bronchopulmonary dysplasia (BPD)

    Time frame: 36 weeks' postmenstrual age

    defined as requirement for supplemental oxygen at 28 days of life or requirement for supplemental oxygen at 36 weeks' postmenstrual age

  5. Necrotizing enterocolitis

    Time frame: 7 days after extubation

    defined according to modified Bell's criteria (stage 2 to 3)

  6. Gastrointestinal perforation

    Time frame: 7 days after extubation

    diagnosed radiologically or at operation

  7. Nosocomial sepsis

    Time frame: 7 days after extubation

    defined as positive blood or cerebrospinal fluid (CSF) cultures taken after five days of age

  8. Retinopathy of prematurity (ROP)

    Time frame: 40 weeks corrected postnatal age

    stage 3 or greater (International classification)

  9. Duration of hospitalisation or Length of stay (in days)

    Time frame: From admission to first discharge from hospital, assessed up to 6 months

    Number of days in hospital until first discharge

Sponsors and collaborators

Lead sponsor

King Fahad Armed Forces Hospital

Other Gov

Registry information

Official study title

Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation: A Randomised Control Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 3, 2018
Registry last updated
Jul 27, 2021

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.

Published trials that share one or more normalized conditions with this study.