Assessment of NeuroBOX and NeuroPAP in Infants.

NCT ID: NCT03650478

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-10-31

Brief Summary

Non-invasive ventilation (NIV, delivered via a mask or cannulas) permits to reduce the need for tracheal intubation in infants who needs a ventilatory support. NIV can be delivered with nasal CPAP (continuous positive airway pressure) or NIPPV (nasal intermittent positive pressure ventilation). The synchronization of the respiratory support according to the patient's demand is very difficult to obtain in infants with the conventional ventilatory modes. In all these ventilatory modes, the end-expiratory pressure (PEEP) is fixed and set by the clinician. However, since infants are prone to alveolar collapse and must compensate for a non-compliant chest wall, an active and ongoing management of PEEP is very important to prevent the lung de-recruitment.

A new respiratory support system (NeuroPAP) has been developed to address these issues of synchronization and control of PEEP. This new system uses diaphragmatic tonic activity (Edi) that reflects the patient's efforts to increase lung recruitment and therefore it continuously controls the delivery of assist continuously both during inspiration (like NAVA) and during expiration, allowing a unique neural control of PEEP.

A new device, the NeuroBOX, permits to deliver NIV with NeuroPAP, CPAP, or NIPPV, and also to serve as a cardio-respiratory monitor, tracking and displaying cardiac and respiratory signals, trends, and cardio-vascular events.

The two main objectives of this study are: 1- To evaluate the clinical impact of NeuroPAP in infants with high tonic Edi; 2- To characterize the cardio-respiratory pattern and its relationship with cerebral perfusion of infants with noninvasive support, using the monitoring capacity of the NeuroBOX.

The investigators expect that NeuroPAP will permit to improve the efficiency of NIV in infants, through the better synchronization and the personalization of the expiratory pressure level in response to the patient needs.

This study will be conducted in two subgroups of patients at high risk of elevated tonic Edi and of cardio-respiratory events: a subgroup of premature infants and a subgroup of infants with bronchiolitis.

Conditions

Pediatric Respiratory Diseases; Bronchiolitis; Infant Respiratory Distress Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Premature infants group

NeuroPAP ventilation (2h) and NeuroBox monitoring (23h)

Group Type: EXPERIMENTAL

NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)

Intervention Type: DEVICE

Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (3 hours). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted

Bronchiolitis group

NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)

Group Type: EXPERIMENTAL

NeuroPAP ventilation (2h) and NeuroBox monitoring (23h)

Intervention Type: DEVICE

Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (1 hour). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted

Interventions

NeuroPAP ventilation (2h) and NeuroBox monitoring (23h)

Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (1 hour). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted

Intervention Type: DEVICE

NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)

Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (3 hours). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

For premature infants group:

• Preterm infants born at a gestational age (GA) between 25 weeks (+0/7 days) and 34 weeks inclusively
• With post-birth age : > 2 days (for birth GA >28 weeks) or > 6 days (GA <28weeks) and < 4 months
• on non-invasive support, including CPAP, NIPPV, or NAVA, with settings in the following range : Maximal inspiratory pressure (total, including PEEP) ≤ 20 cmH2O, and PEEP between 4 and 9 cmH2O, and FiO2 < 50%

For bronchiolitis group:

• Infants with a weight < 5kg and a clinical diagnosis of bronchiolitis.
• on non-invasive support, including CPAP, NIPPV, or NAVA with settings in the range: Delivered inspiratory pressure (total, including PEEP) ≤ 20 cmH2O and PEEP: 5-9 cmH2O, and FiO2 <60 %
• With persisting respiratory failure: presence of at least one of the following criteria:

• Respiratory rate > 50 /min
• Symptoms of respiratory distress: mWCAS > 3
• FiO2 > 30% -
• Inspiratory Edi consistently > 15 µV

Exclusion Criteria

• Suspected or proven pneumothorax;
• Patient on high-flow nasal cannula or on NAVA;
• Contra-indications to the placement of a new nasogastric tube (e.g. severe coagulation disorder, malformation or recent surgery in cervical, nasopharyngeal or esophageal regions);
• Hemodynamic instability requiring inotropes;
• Severe respiratory instability requiring imminent intubation according to the attending physician, or FiO2 > 50% to achieve a SpO2>90%, or PaCO2 > 75 mmHg on the last blood gas;
• Patient for whom a limitation of life support treatments is discussed or decided;
• Refusal by the treating physician;
• Refusal by the parents or legal guardians.

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maquet Critical Care

UNKNOWN

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr Guillaume Emeriaud

Principal Investigator, Intensivist, Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillaume Emeriaud, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Sainte Justine, Université de Montréal

Locations

St. Justine's Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CHUSJ-1841

Identifier Type: -

Identifier Source: org_study_id