A Randomized Controlled Trial Comparing Neurally Adjusted Ventilatory Assist (NAVA) with Synchronized Intermittent Mandatory Ventilation (SIMV+PS) in Preterm Infants with Respiratory Distress Syndrome (RDS)

UMIN ID: UMIN000055670

Registered date:01/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: A neonate born between 26 weeks 0 days and 31 weeks 6 days of gestation, admitted to our neonatal intensive care unit from October 1, 2024, to September 30, 2025, with a diagnosis of respiratory distress syndrome
• Date of first enrollment: 2024/10/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

SIMV and PS:Initial Settings,Weaning,and Extubation Criteria are the same as standard clinical practice.Initial Settings:Peak Inspiratory Pressure(PIP):20cmH2O,Positive End-Expiratory Pressure(PEEP):5cmH2O,Respiratory Rate:40breaths per min,Inspiratory Time(Ti):0.35seconds and Pressure Support(PS):12cmH2O.Volume Guarantee(VG) Mode:VG mode will not be used immediately after birth. It will be added after confirming the absence of atelectasis, pneumothorax, malposition of the endotracheal tube, or decreased lung field transparency on chest X-ray.When using VG mode,tidal volume will be set to 4-6ml based on body weight.Weaning:The PIP will be reduced while maintaining a tidal volume of 4-6ml based on body weight.PEEP will be reduced to 4-5cmH2O.Respiratory rate will be decreased by 10breaths/min, while maintaining PaCO2 at 40-65mmHg and pH greater than or equal to 7.25, confirmed by blood gas analysis.PS will be adjusted to 30-50% of(PIP-PEEP) and gradually reduced to below30%.Extubation Criteria:Extubation will be performed when the following criteria are met:FiO2 less than or equal to 0.4,Mean Airway Pressure (MAP) less than or equal to 8cmH2O,Respiratory rate of 16-20breaths per min,PSless than or equal to 30% of (PIP-PEEP) and Blood gas analysis confirming pH greater than or equal to 7.25and PaCO2 less than or equal to 60mmHg.Post Extubation Respiratory Management:NIPPV(Non Invasive Positive Pressure Ventilation)will be used. Settings:Peak Inspiratory Pressure (PIP):16cmH2O or PIP which is added 2 to pre extubated PIP, Positive End Expiratory Pressure(PEEP):6cmH2O, Inspiratory Time(Ti):0.5-0.6seconds,Respiratory Rate:25-40breaths per min,FiO2:less than or equal to 0.4 and One hour after extubation and for the following three days.
NAVA:Initial Settings, Weaning, and Extubation Criteria are the same as standard clinical practice. Initial Settings:NAVA Level:2cmH2O,Positive End-Expiratory Pressure (PEEP):7cmH2O, Apnea Time:2seconds, Pressure Level Above PEEP in Backup:10 cmH2O,Backup Rate: 40breaths per min, Inspiratory Time (Ti): 0.4seconds and safety limit for PIP:25cmH2O.Weaning:The peak diaphragm electrical activity(Edi peak) will be maintained at 5-15while decreasing NAVA level by 0.2-0.3per day.PEEP will be reduced while maintaining the minimum diaphragm electrical activity (Edi mini) at less than or equal to 1.The apnea time will be extended to achieve a backup percentage of approximately 10%. Extubation Criteria: Extubation will be performed when the following criteria are met:FiO2 0.4, PIP less than or equal to 16cmH2O, NAVA Level less than or equal to 1.0 and Apnea Time greater than or equal to 4seconds.After modification, if Edi peak is maintained at 5-15and Edi mini less than or equal to 1, the NAVA mode will be switched to SIMV and PS while retaining the Edi catheter. Settings during the switch will include: FiO2 less than or equal to 0.4, PIP 16cmH2O, NAVA Level 1.0 and Apnea Time greater than or equal to 4seconds. After modification, if Edi peak is maintained at 5-15and Edi mini less than or equal to 1, the NAVA mode will be switched to SIMV and PS while retaining the Edi catheter. Settings during the switch will include: FiO2 less than or equal to 0.4, MAP less than or equal to 8cmH2O, respiratory rate of 16-20breaths per min, and PS less than or equal to 30% of(PIP-PEEP). Blood gas analysis will confirm pH greater than or equal to 7.25and PaCO2 less than or equal to 60mmHg before extubation. Post extubation Respiratory Management: NIPPV will be used.The NIPPV management after NAVA is the same as the management after SIMV and PS.

Outcome(s)

• Primary Outcome: Duration of endotracheal intubation
• Secondary Outcome: hospitalization period in NICU,hospitalization period, weight gain rate, age at achieving enteral nutrition (WQ100) and age at achieving full enteral nutrition.

Key inclusion & exclusion criteria

• Age minimum: 1days-old
• Age maximum: 1days-old
• Gender: Male and Female
• Exclude criteria: Cases of tracheomalacia, bronchomalacia, and pulmonary hypoplasia. Cases of congenital gastrointestinal diseases such as esophageal atresia and small bowel atresia. Cases of chromosomal abnormalities, neuromuscular diseases, and congenital heart diseases. Cases where the umbilical artery blood pH at birth or the initial blood gas pH of the patient was less than 7.0. Cases where it was not possible to explain the randomized controlled trial within 23 hours of birth, and the assigned respiratory support could not be used within 24 hours of birth. Cases who are deemed inappropriate by the physician.

Related Information

• Primary Sponsor: Kagoshima University Kagoshima City Hospital Neonatology
• Source(s) of Monetary Support: Japanese Society of Perinatal and Neonatal Medicine