Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress

Neonatal Respiratory Distress Clinical Trial

— TONIPEP  

Official title:

Tolerance of Nasal High Frequency Percussive Ventilation Versus Nasal CPAP in Neonatal Respiratory Distress in Term and Preterm (> 33 Weeks of Gestation) Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02030691
• Other study ID #: CHUBX 2013/10
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2014
• Last updated: July 22, 2015
• Start date: May 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2015
• Source: University Hospital, Bordeaux
• Contact: Laurent RENESME, MD
• Phone: +33 (0)5 56 79 55 39
• Email: laurent.renesme[@]chu-bordeaux.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Respiratory distress is the main cause of morbimortality in preterm and term neonates. In most of the case, these babies required the use of positive end expiratory pressure (PEEP) delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is widely used in neonatal intensive care unit. Nasal high frequency percussive ventilation (nHFPV) can be used as non invasive device to deliver PEEP, and improved lung clearance.

We hypothesized that nHFPV can be used to deliver PEEP in preterm and term newborn with respiratory distress with the same tolerance as nCPAP. To compare the tolerance of these devices we used cerebral tissue oxygenation (rSO2c) measured by near infrared spectroscopy (NIRS).

Description:

The objective is to compare nHFPV versus nCPAP tolerance for providing PEEP in newborn respiratory distress.

High frequency percussive ventilation (HFPV) is a pressure limited, time-cycled, high-frequency mode of ventilation that delivers subphysiologic tidal volumes at rapid rates and that can be used via an endotracheal tube, a nasal probe or a face mask. In burned children, it has been shown to provide the same or improved oxygenation and ventilation at lower peak pressure when compared with conventional ventilation. In neonates, HFPV has been described in hyaline membrane disease and acute respiratory failure ventilation with improvement in oxygenation, significant decrease in PaCO2 and no change in central hemodynamics and we recently shown that nasal HFPV is more effective than nasal continuous positive airway pressure in transient tachypnea of the newborn. This stud is a cross-over clinical trial. For each patient enrolled, the 2 respiratory devices (nHFPV and nCPAP) were used one after the other for 15 minutes each. Randomization determines which device to use in first (group A nCPAP then nHFPV, group B (nHFPV then nCPAP). During the experiment, rSO2c is continuously recorded by NIRS, and oxygenation and capnia are monitored in a non invasive way by transcutaneous oxygen saturation and transcutaneous capnia measurement. Ventilators' setting (PEEP, FiO2) will be modified to achieve oxygen and capnia targets (SpO2 > 90%, and under 95% if FiO2>0.21, Capnia between 5 to 7 kPa). Duration of patient follow up is 30 minutes. After these 30 minutes, if PEEP is always needed, patients undergo nCPAP. If needed during the experiment, patients can receive mechanical ventilation (the criteria for mechanical ventilation are the same as those used in clinical practice).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Minutes

Eligibility

Inclusion Criteria:

• Inborn neonate.

• Delivered by vaginal delivery or caesarean section.

• Gestational age greater than or equal to 33 weeks of gestation.

• Birth weight > 1kg.

• Respiratory distress with a Silverman score greater than or equal to 4 after 10 minutes of life.

• Signed parental informed consent.

Exclusion Criteria:

• Meconium aspiration syndrome.

• Congenital anomalies such as heart anomalies, congenital cystic adenomatoid malformation, diaphragmatic hernia…

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Respiratory Distress
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Nasal continuous airway positive pressure (nCPAP)

• Nasal high frequency percussive ventilation (nHFPV)

Locations

Country	Name	City	State
France	Service de Néonatalogie - Maternité - Hôpital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of cerebral tissue oxygenation (rSO2c) by near infrared spectroscopy (NIRS). We compared the mean of the variation of rSO2c during the last 5 minutes for each device (nHFPV and nCPAP).		30 minutes after the inclusion	No
Secondary	Measurement of transcutaneous capnia and oxygen saturation; variation of heart rate, breath rate and blood pressure; ventilators' setting (PEEP, FiO2).		30 minutes after the inclusion	No