- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01326975
Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants
Effects of Continuous Positive Airway Pressure (CPAP) Delivered by High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure on the Diaphragm Electrical Activity in Very Low Birth Weight Preterm Infants
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Many preterm very low birth weight infants require continuous positive airway pressure(CPAP) for breathing support because of lung immaturity. CPAP can be delivered by the infant flow(TM) device which is well studied. Prolonged use of nasal prongs CPAP has been shown to cause discomfort and, rarely, nasal injury leading to long term disfigurement. On the other hand, High flow nasal cannula (HFNC) ,which is another modality of delivering CPAP, creates less pressure on the nose and less disfiguring effect but previous research showed that the use of HFNC may be less effective than IF-CPAP in providing breathing support in these infants.
We plan to study 10 stable preterm infants born less than 32 weeks' gestation and 1.5 kilograms at birth after being stable for at least 48hours on IF-CPAP. babies will be randomized to start on IF-CPAP or HFNC for 30 minutes. After 45 minutes of adaptation, baby will be switched to the other modality for another 30 minutes. By inserting a specialized feeding tube with sensors into the stomach, we can measure the electrical activity of the diaphragm (EAdi). By analysing EAdi with each modality of delivering CPAP, we want to directly assess how HFNC affects breathing compared to IF-CPAP.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Ontario
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Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Birth weights ≤ 1500g
- Gestational age less than 32 week
- Stable on nasal continuous positive airway pressure (CPAP) of 5-6cmH20 support for at least 48 hours
- Treated with methylxanthines for apnea of prematurity
- In less than 35% oxygen
Exclusion Criteria:
- Congenital and acquired problem of the gastrointestinal tract
- Phrenic nerve injury and/or diaphragm paralysis
- Esophageal perforation/tracheoesophageal fistula
- Congenital/acquired neurological deficit and/or seizures
- Hemodynamic instability
- Congenital heart disease (including symptomatic patent ductus arteriosus)
- Undergoing treatment for sepsis or pneumonia
- Use of muscle relaxants, narcotic analgesics, or gastric motility agents
- Congenital anomalies of respiratory tract (e.g. CCAM)
- Infants requiring more than 35% oxygen
- Infants with facial anomalies
- Infants with pneumothorax and/or pneumomediatinum
- Infants in the immediate postoperative period
- Infants with significant gastric residues and vomiting
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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EAdi 1
babies in this group will first receive CPAP through IF-CPAP for 30 minutes.
After another 45 minutes, they will be switched to HFNC for 30 minutes.
EAdi will be recorded for the last 15 minutes of each 30 minutes period.
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EAdi 2
babies in this group will first receive CPAP through HFNC for 30 minutes.
After another 45 minutes, they will be switched to IF-CPAP for 30 minutes.
EAdi will be recorded for the last 15 minutes of each 30 minutes period.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The difference in the tonic EAdi between IF-CPAP and HFNC .
Délai: During the 4-hour study period.
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Patients will be randomized in two groups, one group will start on IF-CPAP for 30 minutes.
After another 45 minutes, this group will be switched to HFNC for another 30 minutes.
The other group will start on HFNC and then switched to IF-CPAP.
EAdi will be analyzed in the last 15 minutes of each 30 minutes period.
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During the 4-hour study period.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Difference in the number of apnea episodes (breathing pauses) on EAdi recorded with each modality.
Délai: During the 4-hour study period.
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During the 4-hour study period.
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Difference in episodes of clinically significant apnea with HFNC and IF-CPAP.
Délai: During the 4-hour study period.
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During the 4-hour study period.
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Indices of respiratory muscle effort (inspiratory and expiratory) will be calculated from Edi waveform.
Délai: During the 4-hour study period.
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These indices include the phasic Edi to the peak, mean inspiratory Edi, Edi-time product, post inspiratory activity and all neural timings.
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During the 4-hour study period.
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Michael Dunn, MD, Sunnybrook Health Sciences Centre
- Chercheur principal: Nehad Nasef, M.B.B.Ch, Sunnybrook Health Sciences Centre
- Chercheur principal: Maureen Reilly, RRT, Sunnybrook Health Sciences Centre
- Chercheur principal: Patti Schurr, RN(EC), Sunnybrook Health Sciences Centre
- Chercheur principal: Jennifer Beck, Ph.D., Unity Health Toronto
- Directeur d'études: Eugene Ng, MD, Sunnybrook Health Sciences Centre
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
- 254-2010
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