sNIPPV Versus NIV-NAVA in Extremely Premature Infants

NCT04068558 | Completed

• 2 other identifiers: EASYNNEO2019-A00420-57
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to demonstrate a significant decrease in asynchrony with NIV-NAVA using the Servo n ventilator (Getinge, Sweden), as compared to abdominal triggered (Graseby capsule) synchronized nasal intermittent positive pressure ventilation (sNIPPV) using the Infant Flow CPAP device (Care Fusion, USA). All of the data obtained can be used to develop a large-scale study aimed at reducing the rate of re-intubation in the study population (pilot study). In fact, the re-intubation criteria for extremely premature children are based on clinical criteria (desaturations, apnea, signs of respiratory control) and paraclinical criteria (FiO2, Potential hydrogen (pH), PCO2). The results of this pilot study will help to develop an adapted methodology and to calculate a sample size to compare the 2 modes of NIV to the test on a clinical criterion: the rate of re-intubation after extubation, which is classically high in these patients.

Conditions

Premature Birth; Ventilator Lung; Newborn

Keywords

neurally adjusted ventilatory assist; synchronized nasal intermittent positive pressure ventilation

Outcome Measures

Primary Outcomes (1)

• Asynchrony index

  Asynchrony index as previously defined in the literature using the following parameters: Ineffective effort (IE): presence of an inspiratory electromyographic signal not followed by pressurization; Late cycling (LC): a cycle with an inspiratory time greater than twice the patient's neural inspiratory time; Premature cycling (PC): a cycle with an inspiratory time shorter than the the neural inspiratory time; Double triggering (DT): two ventilator-delivered cycles triggered by one neural inspiration; Auto triggering (AT): a cycle delivered by the ventilator in the absence of EAdi signal.

  4 hours

Secondary Outcomes (12)

• Components of the Asynchrony index

  4 hours

• Mean change in electric activity of the diaphragm (Edi)

  4 hours

• Apnoea

  4 hours

• Desaturations

  4 hours

• Bradycardia

  4 hours

Study Arms (2)

VNI-NAVA/sNIPPV

EXPERIMENTAL

Ventilation of the child non-invasive ventilation (VNI) NAVA then sNIPPV

Device: VNI-NAVA/sNIPPV

sNIPPV/VNI-NAVA

EXPERIMENTAL

Ventilation of the child sNIPPV then non-invasive ventilation (VNI) NAVA

Device: sNIPPV/VNI-NAVA

Interventions

VNI-NAVA/sNIPPV DEVICE

Ventilation of the child in NIV-NAVA for 2 hours then ventilation of the child in sNIPPV for two hours. The ventilation periods consist of one hour of wash-out and one hour of data collection

VNI-NAVA/sNIPPV

sNIPPV/VNI-NAVA DEVICE

Ventilation of the child in sNIPPV for 2 hours then ventilation of the child in NIV-NAVA for two hours. The ventilation periods consist of one hour of wash-out and one hour of data collection

sNIPPV/VNI-NAVA

Eligibility Criteria

• Age: 3 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Premature infants born before 28 weeks of gestation
• Corrected age below 32 weeks of gestation
• Postnatal age \> or = 3 days
• Receiving NIPPV (any mode)
• Equipped with an Edi catheter
• Receiving caffein treatment
• Parental consent
• Recipient of French social security coverage
• More than 1 apnea/hour requiring bag-mask ventilation, or pH\<7.2 and/or TcPCO2\>70, or FiO2\>0.6 in the previous 6 hours.
• Nasal trauma precluding the use of non-invasive ventilation
• Major congenital anomalies
• Grade III or higher intraventricular hemorrhage
• Use of anesthetics or sedative within the past 24 hours, except opioids for iatrogenic withdrawal treatment
• Hemodynamic compromise defined as a mean blood pressure less than gestational age (in mmHg) or a capillary refill time more than 3 seconds
• Neuro-muscular disorders

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized crossover trial in the Neonatal Intensive Care Unit

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: December 9, 2019
• Primary Completion: March 3, 2021
• Study Completion: March 11, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)