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Trial record 38 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

Breathing Variability and NAVA in Neonates (BRAVe NANO)

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ClinicalTrials.gov Identifier: NCT04000568
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
Politecnico di Milano
Information provided by (Responsible Party):
Anna Lavizzari, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Condition or disease Intervention/treatment
Neonatal Respiratory Distress Syndrome Prematurity Other: Respiratory support: NAVA -NIV and PC-NIV

Detailed Description:

Preterm infants matching the inclusion criteria (listed elsewhere) will be enrolled in a cross- over trial of two modes of non-invasive respiratory support: nasal intermittent positive pressure ventilation (PC-NIV) and NAVA NIV (Sevo-n Neonatal Ventilator, GETINGE, Solna, Sweden). Parental consent will be collected prior to the study. A 20-minute registration of ventilator parameters during assistance on NAVA-NIV will allow calculating the mean PIP (peak inspiratory pressure), in order to compare the two modes at the same level of PIP. The ventilator settings other than PIP (i.e. FiO2 (fraction of inspired oxygen), PEEP (positive end-expiratory pressure), IT (inspiratory time), RR (respiratory rate), NAVA level) will be based on the setting optimized by the attending physicians prior to the study entry. FiO2 will be adjusted in order to maintain SpO2 88-93% in infants ≤ 32 weeks of postconceptional age, 90-95% in infants > 32 weeks of postconceptional age. Infants will then receive a randomized sequence of 1-hour assistance by NAVA NIV and 1-hour assistance PC-NIV or vice-versa. Infants will receive respiratory support in a standardized supine position during the study period.

Two, high-resolution, small cameras will be placed in the infant's incubator to detect chest and abdominal movements, by means of two markers placed on the infant's chest and abdomen. Ventilators parameters (flow, pressure, volume, the electrical activity of the diaphragm), vital signs (SpO2, HR (heart rate), ABP( arterial blood pressure)), transcutaneous gases, changes in end-expiratory lung volume will be collected continuously. Episodes of apnea, bradycardia or desaturations and the number of interventions required by the nurses and the attending physicians during the study (e.g. adjustment of the interface, suctioning, interventions to provide comfort or optimize the respiratory support...) will be also collected during the study. Patients' comfort will be assessed at the end of each sequence by the attending nurse by means of the COMFORT scale. Lung mechanics will be measured at the end of each sequence by means of the Forced Oscillation Technique.

Data will be then analysed and compared offline.


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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Breathing Pattern Variability in Preterm Infants: Effect of Non-invasive Neurally Adjusted Ventilatory Assist (NAVA-NIV) Versus Nasal Intermittent Positive Pressure Ventilation (PC-NIV), a Crossover Study
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : September 30, 2020


Group/Cohort Intervention/treatment
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
The infants enrolled will receive respiratory assistance by NAVA-NIV and PC-NIV in a randomized order




Primary Outcome Measures :
  1. Change in breath-by-breath variability of tidal breathing amplitude [ Time Frame: over the last 30 minutes of each step (crossover trial, 2 steps, 1 hour-step) ]
    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.


Secondary Outcome Measures :
  1. Respiratory Rate [ Time Frame: 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 ]
    Respiratory rate (breaths/min) will be recorded from the ventilator

  2. Inspiratory Time [ Time Frame: 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 (msec) will be recorded from the ventilator tracing

  3. Duty Cycle [ Time Frame: 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 (Inspiratory Time/ Total Time), will be calculated from the ventilator tracing

  4. Total Respiratory System Oscillatory Resistance [ Time Frame: at the end of each 1-hour step of the trial (crossover trial, 2 steps, 1 hour-step) ]
    Total Respiratory System Oscillatory Resistance will be measured by the Forced Oscillation Technique (FOT) at the end of each step, by superimposing to the ventilator waveform an oscillatory pressure of small amplitude at 10 Hz (Fabian, ACUTRONIC Medical Systems AG, Switzerland).

  5. Total Respiratory System Oscillatory Reactance [ Time Frame: at the end of each 1-hour step of the trial (crossover trial, 2 steps, 1 hour-step) ]
    Total Respiratory System Oscillatory Reactance will be measured by the Forced Oscillation Technique (FOT) at the end of each step, by superimposing to the ventilator waveform an oscillatory pressure of small amplitude at 10 Hz (Fabian, ACUTRONIC Medical Systems AG, Switzerland).

  6. SpO2/FiO2 (Fraction on inspired oxygen) [ Time Frame: 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 ]
    SpO2 and FiO2 will be monitored continuously and FiO2 will be adjusted to the target SpO2 88-93% in infants ≤ 32 weeks of postconceptional age, SpO2 90-95% in infants > 32 weeks of postconceptional age.

  7. tpCO2, Transcutaneous Carbon Dioxide Partial Pressure (mmHg) [ Time Frame: 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 ]
    tpCO2 will be monitrored continuously over the study period and recorded at specific time points

  8. Rate of apneas, desaturations, bradycardias [ Time Frame: over 1 hour, for each step (in a 2-step crossover trial, 1-hour step) ]
    Episodes of apnoeas, desaturations, bradycardias will be recorded over each study period

  9. Rate of patient-ventilator asynchronies [ Time Frame: over 1 hour, for each step (in a 2-step crossover trial, 1-hour step) ]
    Patient-ventilator asynchronies will be calculated by continuous recording of ventilator parameters (flow, pressure, volume and electrical diaphragmatic activity) and by continuous recording of abdominal and chest movements by high resolution cameras placed in the incubators and skin markers on abdomen and chest


Other Outcome Measures:
  1. Patient's comfort: COMFORT-B scale [ Time Frame: at the end of each 1-hour step ]
    Patient's comfort will be assessed by the attending nurse at the end of each step by means of the COMFORT-B scale (COMFORT behavioural scale). The COMFORT-B scale is a validated tool for assessing patients' comfort in Pediatric Intensive Care Unit.It includes the following items for comfort evaluation: alertness, calmness, respiratory response, cry, physical movements, muscle tone, facial tension. For each item a descriptive scale form 1 (the best) to 5 (the worst) is indicated and the operator can choose what is the most appropriate for the patient.

  2. Number of caregivers interventions required [ Time Frame: at the end of each 1-hour step ]
    The number of interventions required to the attending personnel during each step will be also recorded: for instance interventions to improve comfort, to adjust the ventilator interface, to optimize the efficacy of respiratory support, suctioning ...



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
preterm infants born < 37 weeks of gestation, requiring non-invasive respiratory support
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000568


Contacts
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Contact: Anna Lavizzari, MD +39 3208715095 anna.lavizzari@gmail.com
Contact: Mariarosa Colnaghi, MD +39 0255032234 mariarosa.colnaghi@mangiagalli.it

Locations
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Italy
NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Recruiting
Milan, MI, Italy, 20122
Contact: Anna Lavizzari, MD    +39 3208715095    anna.lavizzari@gmail.com   
Contact: Mariarosa Colnaghi, MD    +39 02 5503 2234    mariarosa.colnaghi@mangiagalli.it   
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Politecnico di Milano
Investigators
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Principal Investigator: Anna Lavizzari, MD Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico
  Study Documents (Full-Text)

Documents provided by Anna Lavizzari, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Publications:
Ancel PY, Goffinet F; EPIPAGE-2 Writing Group, Kuhn P, Langer B, Matis J, Hernandorena X, Chabanier P, Joly-Pedespan L, Lecomte B, Vendittelli F, Dreyfus M, Guillois B, Burguet A, Sagot P, Sizun J, Beuchée A, Rouget F, Favreau A, Saliba E, Bednarek N, Morville P, Thiriez G, Marpeau L, Marret S, Kayem G, Durrmeyer X, Granier M, Baud O, Jarreau PH, Mitanchez D, Boileau P, Boulot P, Cambonie G, Daudé H, Bédu A, Mons F, Fresson J, Vieux R, Alberge C, Arnaud C, Vayssière C, Truffert P, Pierrat V, Subtil D, D'Ercole C, Gire C, Simeoni U, Bongain A, Sentilhes L, Rozé JC, Gondry J, Leke A, Deiber M, Claris O, Picaud JC, Ego A, Debillon T, Poulichet A, Coliné E, Favre A, Fléchelles O, Samperiz S, Ramful D, Branger B, Benhammou V, Foix-L'Hélias L, Marchand-Martin L, Kaminski M. Survival and morbidity of preterm children born at 22 through 34 weeks' gestation in France in 2011: results of the EPIPAGE-2 cohort study. JAMA Pediatr. 2015 Mar;169(3):230-8. doi: 10.1001/jamapediatrics.2014.3351. Erratum in: JAMA Pediatr. 2015 Apr;169(4):323. Alberge, Catherine [Corrected to Alberge, Corine].

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Responsible Party: Anna Lavizzari, Principal Investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT04000568     History of Changes
Other Study ID Numbers: BRAVe NANO (NIV)
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the study protocol, statistical analysis plan an Informed Consent (only in the original language, available in English under request) will be available from the study protocol submission date. Analytic code status: still undecided.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: at protocol submission
Access Criteria: free

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Lavizzari, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Preterm Infant
Respiratory Distress Syndrome
Non-invasive respiratory Support
Neurally Adjust Respiratory Assist (NAVA)
Nasal Intermittent Positive Pressure Ventilation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases