Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants Study

NCT02590757 | Completed DMC

• 1 other identifier: 2015-1917
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled study to compare if a a non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure (N-CPAP) after extubation in infants' \< 30 weeks of gestation.

Conditions

Endotracheal Extubation; Infant, Premature

Keywords

non-invasive ventilation; non-invasive neurally adjusted ventilatory assist; nasal continuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

• Extubation failure

  Failure criteria * pH \< 7.2 with pCO2 \> 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings * Severe apnea event requiring bag and mask resuscitation * FiO2 \>0.6 to maintain SpO2 ≥ 88% after extubation * Frequent desaturations (\< 85%) ≥ 3/hr not responding to increased ventilatory settings or an increase in Fio2 to 1.0

  extubation - 72 hours

Secondary Outcomes (10)

• FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation

  extubation - 72 hours

• Severe apnea event requiring bag and mask resuscitation

  extubation - 72 hours

• FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation

  extubation - 7 days

• pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings

  extubation - 7 days

• Severe apnea event requiring bag and mask resuscitation

  extubation - 7 days

Study Arms (2)

NIV-NAVA

ACTIVE COMPARATOR

Noninvasive ventilation in this group is practiced with NIV-NAVA

Device: NIV-NAVA

N-CPAP

ACTIVE COMPARATOR

Patients in this group will receive nasal continuous positive airway pressure as routinely in neonatal intensive care unit.

Device: N-CPAP

Interventions

NIV-NAVA DEVICE

Non-invasive neurally adjusted ventilatory assist

NIV-NAVA

N-CPAP DEVICE

Nasal-continuous positive airway pressure

N-CPAP

Eligibility Criteria

• Age: 2 Days - 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• postconceptional age less than 30+0 weeks
• infants who fulfill the the criteria for extubation for 6 hours extubation criteria: Ventilator rate ≤ 25 breaths/min, Peak inspiratory pressure (PIP) ≤ 16cmH2O, Fractional inspired oxygen (FiO2) ≤ 0.3

You may not qualify if:

• conditions which will decrease life expectancy
• major anomalies which will decrease life expectancy
• any anomalous conditions which involve upper and lower airway
• neuromuscular disease

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Children's Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Shin SH, Shin SH, Kim SH, Song IG, Jung YH, Kim EK, Kim HS. Noninvasive Neurally Adjusted Ventilation in Postextubation Stabilization of Preterm Infants: A Randomized Controlled Study. J Pediatr. 2022 Aug;247:53-59.e1. doi: 10.1016/j.jpeds.2022.04.025. Epub 2022 Apr 20.

  PMID: 35460702 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Han-Suk Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Neonatal Intensive Care Unit

Study Record Dates

• First Submitted: October 25, 2015
• First Posted: October 29, 2015
• Study Start: December 10, 2015
• Primary Completion: November 13, 2020
• Study Completion: January 23, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Locations

KR (1)