Breathing Variability and NAVA in Neonates

NCT04000568 | Completed

• 1 other identifier: BRAVe NANO (NIV)
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is a crossover trial, aiming at evaluating the effect of NAVA -NIV compared to Nasal Intermittent Positive Pressure Ventilation (PC-NIV) at the same level of peak inspiratory pressure, in terms of: breath-by-breath variability of tidal breathing amplitude, variability of the other breathing patterns; lung mechanics; gas exchange; rate of episodes of apnea; bradycardia and desaturations; respiratory asynchrony and comfort, in preterm infants \< 37+0 weeks+days post-menstrual age.

Conditions

Neonatal Respiratory Distress Syndrome; Prematurity

Keywords

Preterm Infant; Respiratory Distress Syndrome; Non-invasive respiratory Support; Neurally Adjust Respiratory Assist (NAVA); Nasal Intermittent Positive Pressure Ventilation

Outcome Measures

Primary Outcomes (1)

• Change in breath-by-breath variability of tidal breathing amplitude

  Tidal breathing amplitude will be recorded continuously by mean of two, high-resolution cameras placed inside the infant's incubator and skin (non-invasive) markers. Data will be analysed a posteriori applying the DFA (Detrended Fluctuation Analysis) technique.

  over the last 30 minutes of each step (crossover trial, 2 steps, 1 hour-step)

Secondary Outcomes (9)

• Respiratory Rate

  at the beginning of the study, at 10minutes, 20minutes, 30minutes, 35minutes, 40minutes, 45minutes, 50minutes, 55minutes, for each step, in a 2-step crossover trial, 1-hour step

• Inspiratory Time

  at the beginning of the study, at 10minutes, 20minutes, 30minutes, 35minutes, 40minutes, 45minutes, 50minutes, 55minutes, for each step, in a 2-step crossover trial, 1-hour step

• Duty Cycle

  at the beginning of the study, at 10minutes, 20minutes, 30minutes, 35minutes, 40minutes, 45minutes, 50minutes, 55minutes, for each step, in a 2-step crossover trial, 1-hour step

• Total Respiratory System Oscillatory Resistance

  at the end of each 1-hour step of the trial (crossover trial, 2 steps, 1 hour-step)

• Total Respiratory System Oscillatory Reactance

  at the end of each 1-hour step of the trial (crossover trial, 2 steps, 1 hour-step)

Other Outcomes (2)

• Patient's comfort: COMFORT-B scale

  at the end of each 1-hour step

• Number of caregivers interventions required

  at the end of each 1-hour step

Study Arms (1)

Study Population

All the infants enrolled in the study will receive 1 h of NAVA-NIV and 1h PC-NIV in a cross-over study design

Other: Respiratory support: NAVA -NIV and PC-NIV

Interventions

Respiratory support: NAVA -NIV and PC-NIV OTHER

The infants enrolled will receive respiratory assistance by NAVA-NIV and PC-NIV in a randomized order

Study Population

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

preterm infants born \< 37 weeks of gestation, requiring non-invasive respiratory support

You may qualify if:

• preterm birth \< 37 weeks of gestational age
• need of non-invasive respiratory support
• parental consent

You may not qualify if:

• Major congenital abnormalities of the cardio-respiratory systems
• Severe Respiratory Failure requiring intubation and mechanical ventilation at the time of the study; pH \< 7.25 pCO2\> 65 mmHg; pulmonary hypertension of the newborn requiring pharmacological treatment (Nitric Oxide, Sildenafil)
• Hypoxic-Ischaemic Encephalopathy, neurological disorders which may compromise the integrity of the neural transmission from the brain to the diaphragm
• Contraindication to orogastric tube insertion (e.g. oesophageal atresia, gastric perforation...)
• Haemodynamic instability requiring inotropic agents
• Any condition that would expose the patient to undue risk as deemed by the attending physician

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• Politecnico di Milano: collaborator

Study Sites (1)

NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Location

Related Publications (28)

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MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anna Lavizzari, MD

  Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 27, 2019
• Study Start: May 2, 2019
• Primary Completion: September 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: at protocol submission
• Access Criteria: free

Locations

IT (1)