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- Essai clinique NCT00780624
Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy. Nevertheless, NIPPV has never been used in chinese babies.
The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Chongqing
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Chongqing, Chongqing, Chine, 400042
- Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Newborn infants with birth weight >500 gm.
- Gestational age >24 completed weeks.
- Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: 1) the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support; 2)the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
- No known lethal congenital anomaly or genetic syndromes.
- Signed parental informed consent.
Exclusion Criteria:
- Considered non-viable by clinician (decision not to administer effective therapies)
- Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- Infants known to require surgical treatment
- Abnormalities of the upper and lower airways
- Neuromuscular disorders
- Infants who are >28 days old and continue to require mechanical ventilation with an endotracheal tube
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: NIPPV
The NIPPV group receiving NIPPV treatment.
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Ventilator is Bird VIP.
Ventilator(Bird VIP) is used for NIPPV device.
Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group.
The duration of NIPPV is according to the baby's respiratory condition.
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Comparateur actif: Control
The Control group receiving nCPAP treatment.
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Ventilator is Bird VIP.
Ventilator(Bird VIP) is used for NIPPV device.
Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group.
The duration of NIPPV is according to the baby's respiratory condition.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.
Délai: At 7 days after non-invasive respiratorynsupport.
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At 7 days after non-invasive respiratorynsupport.
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age.
Délai: At 7 days, 28 days and at 36 weeks postmenstraul age
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At 7 days, 28 days and at 36 weeks postmenstraul age
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Yuan Shi, MD, Department of Pediatrics, Daping Hospital, Third Military Medical University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NCR2008053
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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Essais cliniques sur Syndrome de détresse respiratoire
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The Hospital for Sick ChildrenComplétéÉvaluation de HomeCare RN Respiratory EducationCanada