NIV NAVA versus Nasal CPAP in Premature Infants: A Randomized Clinical Trial.


Journal

Neonatology
ISSN: 1661-7819
Titre abrégé: Neonatology
Pays: Switzerland
ID NLM: 101286577

Informations de publication

Date de publication:
2019
Historique:
received: 14 05 2019
accepted: 24 07 2019
pubmed: 6 9 2019
medline: 19 6 2020
entrez: 6 9 2019
Statut: ppublish

Résumé

Noninvasive ventilation is recommended for neonatal respiratory distress to avoid adverse effects of invasive ventilation. The aim of this study was to compare the feasibility of noninvasive neurally adjusted ventilatory assist (NIV NAVA) and continuous positive airway pressure (CPAP) in preterm newborn infants. Forty preterm infants (gestational age 28+0 to 36+6 weeks) requiring CPAP and supplemental oxygen (FiO2 >0.23) for respiratory distress at <48 h of postnatal age were randomized to NIV NAVA or CPAP. The primary endpoint was the inspired oxygen concentration 12 h after study inclusion. Secondary endpoints were the duration of oxygen treatment, total duration of respiratory support, parenteral nutrition, blood gas values, patient comfort, need for invasive ventilation, and treatment complications. The mean FiO2 at the time of study inclusion was 0.29 in both groups. After 12 h of treatment, FiO2 was 0.26 ± 0.07 and 0.26 ± 0.04 in the NIV NAVA and CPAP groups, respectively (difference 0.006, 95% CI -0.4 to 0.5), with no difference between the groups during the course of noninvasive ventilation (p = 0.80). Seven patients (35%) in the NIV NAVA group and 10 (50%) in the control group required intubation (difference 15%, 95% CI -15.5 to 4.3, p = 0.36). Time to intubation, gas exchange, vital parameters, pain scale, treatment complications, and neonatal outcome did not differ between the groups. In the present trial, NIV NAVA had no statistically significant effect on oxygen requirements or the need for invasive ventilation in preterm newborn infants.

Sections du résumé

BACKGROUND
Noninvasive ventilation is recommended for neonatal respiratory distress to avoid adverse effects of invasive ventilation.
OBJECTIVE
The aim of this study was to compare the feasibility of noninvasive neurally adjusted ventilatory assist (NIV NAVA) and continuous positive airway pressure (CPAP) in preterm newborn infants.
METHODS
Forty preterm infants (gestational age 28+0 to 36+6 weeks) requiring CPAP and supplemental oxygen (FiO2 >0.23) for respiratory distress at <48 h of postnatal age were randomized to NIV NAVA or CPAP. The primary endpoint was the inspired oxygen concentration 12 h after study inclusion. Secondary endpoints were the duration of oxygen treatment, total duration of respiratory support, parenteral nutrition, blood gas values, patient comfort, need for invasive ventilation, and treatment complications.
RESULTS
The mean FiO2 at the time of study inclusion was 0.29 in both groups. After 12 h of treatment, FiO2 was 0.26 ± 0.07 and 0.26 ± 0.04 in the NIV NAVA and CPAP groups, respectively (difference 0.006, 95% CI -0.4 to 0.5), with no difference between the groups during the course of noninvasive ventilation (p = 0.80). Seven patients (35%) in the NIV NAVA group and 10 (50%) in the control group required intubation (difference 15%, 95% CI -15.5 to 4.3, p = 0.36). Time to intubation, gas exchange, vital parameters, pain scale, treatment complications, and neonatal outcome did not differ between the groups.
CONCLUSIONS
In the present trial, NIV NAVA had no statistically significant effect on oxygen requirements or the need for invasive ventilation in preterm newborn infants.

Identifiants

pubmed: 31487718
pii: 000502341
doi: 10.1159/000502341
doi:

Types de publication

Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

380-384

Informations de copyright

© 2019 S. Karger AG, Basel.

Auteurs

Merja Kallio (M)

PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland, merja.kallio@oulu.fi.
Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland, merja.kallio@oulu.fi.

Mari Mahlman (M)

PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.
Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.
Children's Hospital, Pediatric Research Center, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.

Ulla Koskela (U)

PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.
Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.

Outi Aikio (O)

PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.
Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.

Maria Suo-Palosaari (M)

Research Unit of Medical Imaging, Physics and Technology, Department of Diagnostic Radiology, Faculty of Medicine, University of Oulu, Oulu, Finland.
Medical Research Center, Oulu University Hospital, University of Oulu, Oulu, Finland.

Tytti Pokka (T)

PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.
Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.

Timo Saarela (T)

PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.
Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.

Mikko Hallman (M)

PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.
Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.

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