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NIV-NAVA Versus Nasal Continuous Positive Airway Pressure (nCPAP) or Non Synchronized NIPPV (Bio-NAVA)

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ClinicalTrials.gov Identifier: NCT02860325
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Fermín García-Muñoz Rodrigo, Complejo Hospitalario Universitario Insular Materno Infantil

Brief Summary:

Mechanical respiratory support of preterm neonates with respiratory distress syndrome (RDS) and/or apnoea of prematurity (AOP) might be associated with adverse effects due to positive pressure (barotrauma), excessive gas delivery (volutrauma) or inadequate volume (atelectrauma). Asynchrony between patient efforts and ventilator support increases patient discomfort, favouring "fighting" the machine, and increases the risk of air trapping and lung overdistension even in patients with non-invasive ventilation (NIV).

Recently, a new modality of synchronization has been available for pediatric and neonatal use: the neurally adjusted ventilatory assist (NAVA), which uses the diaphragmatic electrical activity (Edi) as a signal to start the rise in pressure of the ventilator, and to adjust the tidal volume and the inspiratory time (cycling off) to the patient needs, breath by breath.

The aims of this study are to know whether NIV-NAVA compared to unsynchronized modalities (nCPAP/nIPPV), in infants born < 32 weeks GA with respiratory distress syndrome or requiring prophylactic NIV (immaturity, apnoea) reduces systemic inflammation, measured by serum cytokines concentration, reduces the need for oxygen and respiratory support, and if it increases the probabilities of survival without bronchopulmonary dysplasia (BPD).


Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Apnea of Prematurity Device: NIV-NAVA Device: Conventional Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Neurally Adjusted Ventilatory Assist Versus nCPAP or Non Synchronized NIPPV in Preterm Infants Under 32 Weeks Gestational Age: A Randomized Clinical Trial
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: NIV-NAVA
Patients allocated to non-invasive NAVA
Device: NIV-NAVA
Non-invasive ventilatory support by means of neurally adjusted ventilatory assist (SERVO-n, Maquet, Solna, Sweden)

Active Comparator: Conventional
Patients allocated to nasal CPAP or non-synchronized nasal IPPV
Device: Conventional
Non-invasive ventilatory support by means of nCPAP or non-synchronized nIPPV (Infant Flow, CareFusion)




Primary Outcome Measures :
  1. Survival without moderate or severe bronchopulmonary dysplasia (BPD) [ Time Frame: From admission to first discharge from hospital, assessed up to 1 year ]
    Moderate or severe BPD: dependency on supplemental oxygen and/or ventilatory support at 36 weeks postmenstrual age (PMA) or at hospital discharge (what happens first).


Secondary Outcome Measures :
  1. Blood level of cytokines: Tumor necrosis factor alpha (TNF-α), interleukin (IL) 1 beta (IL-1ß), IL-6, and IL-8. [ Time Frame: T-0: cord blood or immediately after admission; T-1: 48 to 72 h.; T-2: 5th to 7th day of life; and T-3: 28th day of life. ]
    Level of the different cytokines in blood

  2. Total time of ventilatory support (in days) [ Time Frame: From admission to first discharge from hospital, assessed up to 1 year ]
    Number of days with invasive and/or non-invasive ventilatory support

  3. Intervention failure [ Time Frame: From admission to first discharge from hospital, assessed up to 1 year ]
    Need for intubation

  4. Total time of oxygen therapy (in days) [ Time Frame: From admission to first discharge from hospital, assessed up to 1 year ]
    Numer of days with supplementary oxygen

  5. Length of stay (in days) [ Time Frame: From admission to first discharge from hospital, assessed up to 1 year ]
    Number of days in hospital until first discharge


Other Outcome Measures:
  1. Intraventricular haemorrhage (IVH) and grade [ Time Frame: From admission to first discharge from hospital, assessed up to 1 year ]
    According to Papile's classification

  2. Periventricular leukomalacia (PVL) [ Time Frame: From admission to first discharge from hospital, assessed up to 1 year ]
    Cysts or hyperecogenicities for more tan 14 days

  3. Retinopathy of Prematurity (ROP) stage and need for laser therapy [ Time Frame: From admission to first discharge from hospital, assessed up to 1 year ]
    Grade 3 or higher (International classification).

  4. Necrotizing Enterocolitis (NEC) and stage [ Time Frame: From admission to first discharge from hospital, assessed up to 1 year ]
    Grade 2 or greater of Bell's classification



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newborns < 32 weeks GA with neonatal respiratory distress syndrome, diagnosed by clinical and radiological findings who need invasive or non-invasive mechanical ventilation.
  2. Newborns < 29 weeks of gestation (GA) with non-invasive mechanical ventilation at admission indicated as per protocol.
  3. Previous parent or legal guardian authorization (informed consent).

Exclusion Criteria:

  1. Major congenital malformation or chromosomal abnormality.
  2. Absence of informed consent.
  3. Outborn patients.

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): NCT02860325


Locations
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Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Sponsors and Collaborators
Complejo Hospitalario Universitario Insular Materno Infantil
Investigators
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Principal Investigator: Fermín García-Muñoz Rodrigo, Ph.D Head of Neonatal Unit
Publications of Results:
Other Publications:
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Responsible Party: Fermín García-Muñoz Rodrigo, Head of Neonatal Unit, Complejo Hospitalario Universitario Insular Materno Infantil
ClinicalTrials.gov Identifier: NCT02860325    
Other Study ID Numbers: CEIC-CHUIMI-2014/761
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases