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

NCT02860325 | Completed

• 1 other identifier: CEIC-CHUIMI-2014/761
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Distress Syndrome, Newborn; Apnea of Prematurity

Outcome Measures

Primary Outcomes (1)

• Survival without moderate or severe bronchopulmonary dysplasia (BPD)

  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).

  From admission to first discharge from hospital, assessed up to 1 year

Secondary Outcomes (5)

• Blood level of cytokines: Tumor necrosis factor alpha (TNF-α), interleukin (IL) 1 beta (IL-1ß), IL-6, and IL-8.

  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.

• Total time of ventilatory support (in days)

  From admission to first discharge from hospital, assessed up to 1 year

• Intervention failure

  From admission to first discharge from hospital, assessed up to 1 year

• Total time of oxygen therapy (in days)

  From admission to first discharge from hospital, assessed up to 1 year

• Length of stay (in days)

  From admission to first discharge from hospital, assessed up to 1 year

Other Outcomes (4)

• Intraventricular haemorrhage (IVH) and grade

  From admission to first discharge from hospital, assessed up to 1 year

• Periventricular leukomalacia (PVL)

  From admission to first discharge from hospital, assessed up to 1 year

• Retinopathy of Prematurity (ROP) stage and need for laser therapy

  From admission to first discharge from hospital, assessed up to 1 year

Study Arms (2)

NIV-NAVA

EXPERIMENTAL

Patients allocated to non-invasive NAVA

Device: NIV-NAVA

Conventional

ACTIVE COMPARATOR

Patients allocated to nasal CPAP or non-synchronized nasal IPPV

Device: Conventional

Interventions

NIV-NAVA DEVICE

Non-invasive ventilatory support by means of neurally adjusted ventilatory assist (SERVO-n, Maquet, Solna, Sweden)

NIV-NAVA

Conventional DEVICE

Non-invasive ventilatory support by means of nCPAP or non-synchronized nIPPV (Infant Flow, CareFusion)

Conventional

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Major congenital malformation or chromosomal abnormality.
• Absence of informed consent.
• Outborn patients.

Sponsors & Collaborators

• Complejo Hospitalario Universitario Insular Materno Infantil: lead

Study Sites (1)

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Related Publications (8)

• Tremblay LN, Slutsky AS. Ventilator-induced injury: from barotrauma to biotrauma. Proc Assoc Am Physicians. 1998 Nov-Dec;110(6):482-8.

  PMID: 9824530 BACKGROUND

• Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.

  PMID: 24283226 BACKGROUND

• Stein H, Firestone K, Rimensberger PC. Synchronized mechanical ventilation using electrical activity of the diaphragm in neonates. Clin Perinatol. 2012 Sep;39(3):525-42. doi: 10.1016/j.clp.2012.06.004.

  PMID: 22954267 BACKGROUND

• Forel JM, Roch A, Marin V, Michelet P, Demory D, Blache JL, Perrin G, Gainnier M, Bongrand P, Papazian L. Neuromuscular blocking agents decrease inflammatory response in patients presenting with acute respiratory distress syndrome. Crit Care Med. 2006 Nov;34(11):2749-57. doi: 10.1097/01.CCM.0000239435.87433.0D.

  PMID: 16932229 RESULT

• Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

  PMID: 20843245 RESULT

• de la Oliva P, Schuffelmann C, Gomez-Zamora A, Villar J, Kacmarek RM. Asynchrony, neural drive, ventilatory variability and COMFORT: NAVA versus pressure support in pediatric patients. A non-randomized cross-over trial. Intensive Care Med. 2012 May;38(5):838-46. doi: 10.1007/s00134-012-2535-y. Epub 2012 Apr 6.

  PMID: 22481227 RESULT

• Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f.

  PMID: 19593246 RESULT

• Stein H, Howard D. Neurally adjusted ventilatory assist in neonates weighing <1500 grams: a retrospective analysis. J Pediatr. 2012 May;160(5):786-9.e1. doi: 10.1016/j.jpeds.2011.10.014. Epub 2011 Dec 3.

  PMID: 22137670 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Apnea

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fermín García-Muñoz Rodrigo, Ph.D

  Head of Neonatal Unit

  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: Head of Neonatal Unit

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 9, 2016
• Study Start: August 1, 2016
• Primary Completion: November 30, 2017
• Study Completion: December 1, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

ES (1)