Prematurity, Respiratory Failure, Ventilator Lung; Newborn
Conditions
Keywords
Non-invasive Neurally Adjusted Ventilatory Assist NI-NAVA, Nasal Intermittent Positive Pressure Ventilation NIPPV, post extubation
Brief summary
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.
Detailed description
Study Design: Randomised controlled trial Study Setting: single center NICU level III, KFAFH tertiary care center , Jeddah Saudi Arabia
Interventions
DEVICENI-NAVA
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
DEVICENIPPV
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
Sponsors
King Fahad Armed Forces Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised controlled trial * A web generated a block randomisation list. * A block of 4, stratification based on GA, gender & antenatal steriods * Sequentially numbered, opaque and sealed envelopes * Restricted access to envelopes
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure | 72 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death prior to discharge | 90 days from birth | Death |
| Intraventricular haemorrhage IVH (grades III & IV) | 7 days after extubation | defined as haemorrhage causing ventricular dilatation with or without brain parenchymal involvement |
| Pneumothorax | 7 days after extubation | diagnosed radiologically |
| Bronchopulmonary dysplasia (BPD) | 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 |
| Necrotizing enterocolitis | 7 days after extubation | defined according to modified Bell's criteria (stage 2 to 3) |
| Gastrointestinal perforation | 7 days after extubation | diagnosed radiologically or at operation |
| Nosocomial sepsis | 7 days after extubation | defined as positive blood or cerebrospinal fluid (CSF) cultures taken after five days of age |
| Retinopathy of prematurity (ROP) | 40 weeks corrected postnatal age | stage 3 or greater (International classification) |
| Duration of hospitalisation or Length of stay (in days) | From admission to first discharge from hospital, assessed up to 6 months | Number of days in hospital until first discharge |
Countries
Saudi Arabia
Outcome results
None listed