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

King Fahad Armed Forces Hospital

Status: Completed

Conditions: Prematurity; Respiratory Failure; Ventilator Lung; Newborn

Treatments: Device: NIPPV; Device: NI-NAVA

Study type: Interventional

Funder types: Other

Identifiers

NCT03388437

REC 202

Details and patient eligibility

About

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.

Full description

Study Design: Randomised controlled trial

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

Enrollment: 36 patients

Sex: All

Ages: Under 2 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Major congenital malformations or respiratory abnormalities
2. Neuromuscular disease
3. phrenic nerve palsy
4. Intraventricular hemorrhage (IVH) grade III or IV
5. Absence of informed consent
6. Out born infants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

NI-NAVA

Experimental group

Description:

Initial setting; NAVA level of 2; PEEP of 5-6 cm H 2 O, apnea time 5-10 seconds, target Edi maximum between 10-15 and minimum \< 5 for 72 hours post extubation

Treatment:

Device: NI-NAVA

NIPPV

Active Comparator group

Description:

Initial setting; PIP can be increased by 2 cm H 2 O from the pre-extubation PEEP of 5-6 cm for 72 hours post extubation

Treatment:

Device: NIPPV