Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
Nasal High-frequency Oscillatory Ventilation (NHFOV) vs Nasal Continuous Positive Airway Pressure(NCPAP) for Ventilated Newborn Infants With BPD: a Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Supplying with the combined advantages of NCPAP and high-frequency oscillatory ventilation (HFOV) with high carbon dioxide(CO2) removal, no need for synchronisation, non-invasion, less volume/barotraumas, and increased functional residual capacity, nasal HFOV(NHFOV) was considered as a strengthened version of NCPAP. Furthermore, the superimposed oscillations of NHFOV could avoid gas-trapping, and allowed to obviously up-regulate mean airway pressure (MAP) more than NCPAP. Thus, NHFOV might be more beneficial as post-extubation respiratory support strategy to avoid re-intubation and subsequent complications and/or sequelae as compared with NCPAP in preterm infants. Nowadays, NHFOV was increasingly used in neonatal intensive care unit (NICU) around the world due to its convenient operation. A retrospective review has reported the beneficial effects of NHFOV in preterm infants as a remedial measure after failing to other noninvasive modes, including reducing the number of apneas, bradycardias or oxygen desaturations. However, there were rare randomized controlled studies comparing NHFOV with NCPAP in preterm infants with BPD.
We have found that NHFOV is superior to NCPAP in avoiding re-intubation in very preterm infants with the first extubation. The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support strategies on the need for endotracheal ventilation, as well as pressure of CO2(PCO2) level in preterm infants with BPD.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Chen（陈） Long, MD, PhD
- Numéro de téléphone: +8613883559467
- E-mail: neuroclong@126.com
Lieux d'étude
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Chongqing
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Chongqing, Chongqing, Chine, 400014
- Recrutement
- Chen（陈）
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Contact:
- Chen（陈） Long, MD,PhD
- Numéro de téléphone: +8613883559467
- E-mail: neuroclong@126.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Eligibility requirements for neonates:
- The gestational age is less than 32 weeks
- The preterm neonates are diagnosed with BPD and need invasive ventilation
- Extubation and subsequent noninvasive ventilation is ready to be carried out
Exclusion Criteria:
one of the following conditions is needed:
- there were no intraventricular hemorrhage(IVH) grades 3 or 4
- major congenital anomalies
- parents' decision not to participate
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: NHFOV
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
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After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
|
|
Comparateur actif: NCPAP
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
|
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
re-intubation rate
Délai: seven days after extubation
|
the newborn infants with ventilated BPD is reintubated after extubation
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seven days after extubation
|
|
death
Délai: seven days after extubation
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the newborn infants with BPD die
|
seven days after extubation
|
|
the level of carbon dioxide
Délai: seven days after extubation
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the level of carbon dioxide is measure after extubation between groups
|
seven days after extubation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
necrotizing entercolitis(NEC)
Délai: seven days after extubation
|
the newborn infants with BPD is diagnosed with NEC
|
seven days after extubation
|
|
intraventricular hemorrhage(IVH)
Délai: seven days after extubation
|
the newborn infants with BPD is diagnosed with NEC
|
seven days after extubation
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NHFOV for sBPD
Informations sur les médicaments et les dispositifs, documents d'étude
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