King Fahad Armed Forces Hospital
Jeddah, 21159, Saudi Arabia
NCT Number: NCT03388437
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.
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All sexes
Interventional
Not applicable
Jeddah, 21159, Saudi Arabia
Study Design: Randomised controlled trial
Study Setting: single center NICU level III, KFAFH tertiary care center , Jeddah Saudi Arabia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 72 hours
Treatment failure is defined as:
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: 90 days from birth
Death
Time frame: 7 days after extubation
defined as haemorrhage causing ventricular dilatation with or without brain parenchymal involvement
Time frame: 7 days after extubation
diagnosed radiologically
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
Time frame: 7 days after extubation
defined according to modified Bell's criteria (stage 2 to 3)
Time frame: 7 days after extubation
diagnosed radiologically or at operation
Time frame: 7 days after extubation
defined as positive blood or cerebrospinal fluid (CSF) cultures taken after five days of age
Time frame: 40 weeks corrected postnatal age
stage 3 or greater (International classification)
Time frame: From admission to first discharge from hospital, assessed up to 6 months
Number of days in hospital until first discharge
King Fahad Armed Forces Hospital
Other Gov
Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation: A Randomised Control Trial
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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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