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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NI-NAVA | Experimental | 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 |
|
| NIPPV | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure |
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 | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Death prior to discharge | Death | 90 days from birth |
| Intraventricular haemorrhage IVH (grades III & IV) | defined as haemorrhage causing ventricular dilatation with or without brain parenchymal involvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raniah Aljeaid | King Fahad Armed Forces Hospital Jeddah | Principal Investigator |
| Nisreen Kafi | King Fahad Armed Forces Hospital Jeddah | Study Director |
| Fawzia Sabbagh | King Fahad Armed Forces Hospital Jeddah | Study Director |
| Mai Abu Seoud | King Fahad Armed Forces Hospital Jeddah | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Fahad Armed Forces Hospital | Jeddah | 21159 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26178463 | Result | Lee J, Kim HS, Jung YH, Shin SH, Choi CW, Kim EK, Kim BI, Choi JH. Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15. | |
| 22137670 | Result | Stein H, Howard D. Neurally adjusted ventilatory assist in neonates weighing <1500 grams: a retrospective analysis. J Pediatr. 2012 May;160(5):786-9.e1. doi: 10.1016/j.jpeds.2011.10.014. Epub 2011 Dec 3. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2021 |
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Randomised controlled trial
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| 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 |
|
| 7 days after extubation |
| Pneumothorax | diagnosed radiologically | 7 days after extubation |
| Bronchopulmonary dysplasia (BPD) | defined as requirement for supplemental oxygen at 28 days of life or requirement for supplemental oxygen at 36 weeks' postmenstrual age | 36 weeks' postmenstrual age |
| Necrotizing enterocolitis | defined according to modified Bell's criteria (stage 2 to 3) | 7 days after extubation |
| Gastrointestinal perforation | diagnosed radiologically or at operation | 7 days after extubation |
| Nosocomial sepsis | defined as positive blood or cerebrospinal fluid (CSF) cultures taken after five days of age | 7 days after extubation |
| Retinopathy of prematurity (ROP) | stage 3 or greater (International classification) | 40 weeks corrected postnatal age |
| Duration of hospitalisation or Length of stay (in days) | Number of days in hospital until first discharge | From admission to first discharge from hospital, assessed up to 6 months |
| Jun 3, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012131 | Respiratory Insufficiency |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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