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

King Fahad Armed Forces Hospital36 enrolled

Overview

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.

Study Design: Randomised controlled trial Study Setting: single center NICU level III, KFAFH tertiary care center , Jeddah Saudi Arabia

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Interventions

NI-NAVADEVICE

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

NIPPVDEVICE

Eligibility

Sex: ALLMax age: 2 Weeks

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Treatment failure

1. Treatment failure during the first 72 hours post-extubation. 2. 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

Time frame: 72 hours

Secondary Outcomes

Death prior to discharge

Death

Time frame: 90 days from birth

Intraventricular haemorrhage IVH (grades III & IV)

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