Ventilator Weaning Outcome Between NIV-NAVA and Nasal CPAP (or IMV ) Modes in Premature Neonates

NCT04118400 | Unknown

• 1 other identifier: N201907028
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns. The setting and adjustment of the ventilator for premature neonate is not easy, often resulting in poor patient-ventilator interaction, increased work of breathing, patient discomfort and delayed weaning . Recently, a new ventilation mode (NAVA; Neurally Adjusted Ventilatory Assist) mode, allows the respirator to provide a proportional ventilation mode based on the patients' diaphragm electrical activity, which was validated in many domestic and international clinical researches. The NAVA mode improves patient-ventilator interaction, reduces work of breathing and contributes to early weaning and extubation . When participating in this study, the neonate with receive a special oral tube placement, which is used to replace the original gastric tube to monitor the electrical activity of the diaphragm.

Conditions

Respiratory Distress Syndrome in Premature Infant

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation

  Defined as the time from the start of mechanical ventilation, defined as either the time of in the ICU and until successful weaning mechanical ventilator, with successful weaning defined as ≥5 days of unassisted spontaneous breathing after .

  Until the date of discharge from ICU, up to 4 weeks

Secondary Outcomes (24)

• Daily patient physiological blood gas status

  Until the date of discharge from ICU, up to 4 weeks

• Length of ICU stay

  Until the date of discharge from ICU, up to 4 weeks

• Length of hospital stay

  Until the date of discharge from ICU, up to 4 weeks

• Difference in the number of patient ventilator asynchrony

  Entire period of ventilatory support, an average of 7 days

• Ventilation parameters: peak inspiratory pressure in NIV-NAVA

  Entire period of ventilatory support, an average of 7 days

Study Arms (2)

Experimental: NIN-NAVA

* Premature\>30weeks with respiratory distress * PI to determine eligibility or exclusion * Randomize to either NIV-NAVA or Nasal CPAP (NIMV) 1:1 randomization * PI will not be blinded to the intervention (not feasible) * Place the catheter to optimize position * ABG or VBG to be obtained at 2 hrs. post NIV-NAVA * NIV-NAVA settings will be weaned or increased as the clinical situation demands and outlined in the protocol

Procedure: NIV-NAVA

Active Comparator: Nasal CPAP or NIMV

* Premature\>30weeks with respiratory distress * PI to determine eligibility or exclusion * Randomize to either NIV-NAVA or Nasal CPAP (NIMV) 1:1 randomization * PI will not be blinded to the intervention (not feasible) * Place the catheter to optimize position * ABG or VBG to be obtained at 2 hrs. post Nasal CPAP or NIMV * NCPAP or NIMV settings will be weaned or increased as the clinical situation demands and outlined in the protocol

Procedure: Nasal CPAP or NIMV mode

Interventions

NIV-NAVA PROCEDURE

NAVA mode during Non-invasive ventilation

Experimental: NIN-NAVA

Nasal CPAP or NIMV mode PROCEDURE

Nasal CPAP or NIMV mode during Non-invasive ventilation

Active Comparator: Nasal CPAP or NIMV

Eligibility Criteria

• Age: 30 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Premature \>30week and have Respiratory distress

You may qualify if:

• Premature \>30week
• Respiratory distress

You may not qualify if:

• Premature \< 30weeks
• ENT contraindication: fistula
• Contraindication with orogastric tube or nasogastric

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Hsin-yu LI

Taipei, 802, Taiwan

Location

Study Officials

• Hsin-yu LI

  Taipei Medical University Hospital, Taiwan, R.O.C

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 8, 2019
• Study Start: October 31, 2019
• Primary Completion: October 6, 2020
• Study Completion: August 31, 2021
• Last Updated: March 12, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting in January 2022
• Access Criteria: starting in January 2022

Locations

TW (1)