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Clinical Trials/NCT02772835
NCT02772835CompletedNot Applicable

Nasal HFOV vs Nasal CPAP: Effects on Gas Exchange for the Treatment of Neonates Recovering From Respiratory Distress Syndrome. A Multicenter Randomized Controlled Trial

Fondazione Poliambulanza Istituto Ospedaliero8 sites in 2 countries30 target enrollmentStarted: January 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
8
Primary Endpoint
Comparison between nHFOV and nCPAP on gas exchange in premature infants with persistent oxygen need recovering from RDS, particularly on CO2 removal.

Study Overview

Brief Summary

The purpose of this study is to compare the effects of two different techniques of non-invasive ventilation (nCPAP and nHFOV) on gas exchange in preterm infants recovering from respiratory distress syndrome.

Detailed Description

Background - Extremely low birth weight (ELBW) infants usually develop respiratory distress syndrome (RDS), due to lung immaturity, surfactant deficiency and immature respiratory control mechanisms (1). Even though mechanical ventilation is frequently lifesaving, complications are common (2). Tracheal intubation and mechanical ventilation are associated with ventilator-induced lung injury (VILI) and airway inflammation, leading to bronchopulmonary dysplasia (BPD) (3). The mechanisms of this injury involve alveolar over distension, the presence of shear forces and the release of pro-inflammatory cytokines (6), moreover prolonged duration of intubation and mechanical ventilation is associated with an increased risk of death or survival with neurologic impairment (3). In an effort to reduce VILI and so BPD in premature infants, there has been a trend toward increased use of non-invasive forms of respiratory support: nasal continuous positive airway pressure (nCPAP), nasal intermittent positive-pressure ventilation (NIPPV), high-flow nasal cannula (HFNC), nasal high-frequency oscillatory ventilation (nasal-HFOV)(2, 1, 7).

NCPAP is an alternative to intubation and a meta-analysis trials of early nasal CPAP versus intubation and ventilation showed that nasal CPAP reduces the risk of BPD. Nonetheless use of NCPAP in the delivery room may fail in ELBW, with 34 to 83% of such infants requiring subsequent intubation. Furthermore, post extubation support with nCPAP in these infants is associated with a 16-40% failure rate at 1 week (3, 4, 5, 9). NCPAP stabilized the surfactant deficient alveoli and improves oxygenation, but does not necessarily improve alveolar ventilation or partial pressure of carbon dioxide (pCO2) elimination (2, 8).

Some Authors reported the use of nasal high-frequency ventilation (nHFOV) in 14 very low birth weight (VLBW) infants with respiratory failure, using nasopharyngeal tube (3) and they have shown that this technique can lower pCO2 (1).

Other Authors investigated the efficacy of nasal HFOV applied on a single nasopharyngeal tube in an heterogeneous group of 21 infant with moderate respiratory insufficiency and they shown that was effective in reducing pCO2 (10).

No randomized controlled trials have directly evaluated the efficacy of nasal HFOV versus nCPAP with use of nasal prongs/mask in ELBW. There is rationale and support for the idea that high-frequency oscillation using a nasal prongs may improve carbon dioxide elimination in infants and minimizing the need for intubation and mechanical ventilation. In premature infants, HFOV is believed to cause less lung injury than conventional ventilation. So the question can be whether the benefits of HFOV and non invasive (nasal) ventilation are synergistic.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
7 Days to 6 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Birthweight < 1500g and/or
  • •Gestational age < 32 weeks
  • •nCPAP treatment for > 24 h
  • •Oxygen supply to keep SaO2 87-94% for a minimum of 1 h prior to initiation of the study
  • •Parents written informed consent

Exclusion Criteria

  • •Active medical treatment for patent ductus arteriosus
  • •culture proven sepsis
  • •Major congenital malformations
  • •Genetic syndromes
  • •Postoperative recovery period of <24 h

Arms & Interventions

nHFOV

Active Comparator

Starting treatment mode: nHFOV with Medin-cno. Targeted oxygen saturation: 87-94%. Four 1 h study blocks, alternating from the initial mode to the alternate mode twice. All the data will be recorded at 1-min intervals. The following data will be recorded: tcPCO2, tcPO2, heart rate, respiratory rate, SaO2, Silverman score, cer-rSO2, ren-rSO2. Blood pressure will be taken 30 minutes after the beginning of each treatment block. At the beginning of the first period a BGA will be performed in order to test the reliability of the TcPCO2 data. A second capillary BGA will be performed at the end of second period.

Intervention: Medin-cno (Device)

nCPAP

Active Comparator

Starting treatment mode: nCPAP with Medin-cno. Targeted oxygen saturation of 87-94%. Four 1 h study blocks, alternating from the initial mode to the alternate mode twice. All the data will be recorded at 1-min intervals. The following data will be recorded: tcPCO2, tcPO2, heart rate, respiratory rate, SaO2, Silverman score, cer-rSO2, ren-rSO2. Blood pressure will be taken 30 minutes after the beginning of each treatment block. At the be-ginning of the first period a BGA will be performed in order to test the reliability of the TcPCO2 data. A se-cond capillary BGA will be performed at the end of second period.

Intervention: Medin-cno (Device)

Outcomes

Primary Outcomes

Comparison between nHFOV and nCPAP on gas exchange in premature infants with persistent oxygen need recovering from RDS, particularly on CO2 removal.

Time Frame: 4 hours

Infants will be started on the randomized starting mode of either nCPAP or nHFOV: four 1 h study blocks, alternating from the initial mode to the alternate mode twice. During each study block, the following data will be recorded: TcPCO2, TcPO2, heart rate, respiratory rate, SaO2, Silverman score, cer-rSO2 and ren-rSO2. Manual blood pressure will be taken 30 minutes after the beginning of each treatment block. Immediately after entering the study, at the beginning of the first study period, a transcutaneous monitoring of TcPCO2 and TcPO2 will be started and a capillary BGA will be performed in order to test the reliability of the TcPCO2 data. A second capillary BGA will be performed at the end of second study period in both CPAP and nHFOV. To allow for equilibration, we will group and analyze data points from the last 20 min of each treatment block. All the data will be recorded continuously at 1-min intervals directly from the monitor and recorded on a respiratory sheet.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Fondazione Poliambulanza Istituto Ospedaliero
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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