Application pour prédire l'apnée néonatale avec la bradycardie (APNeA)
Application pour prédire l'apnée néonatale avec la bradycardie (étude d'apnée)
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This will be a randomized cross-over trial that will use additional ECG leads connected to a novel device and laptop to determine the accuracy and efficacy of an algorithm to predict, detect, and interrupt episodes of bradycardia for two 4-hour periods. There will be a 4-hour period without vibro-tactile stimulation and a 4-hour period with vibro-tactile stimulation when episodes are predicted or detected.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rachel L. Benz, Clinical Research Nurse Manager, MSN
- Numéro de téléphone: 205-934-2184
- E-mail: rlbenz@uabmc.edu
Sauvegarde des contacts de l'étude
- Nom: Kimberly M. Armstead Clinical Research Coordinator III, B.S.
- Numéro de téléphone: 205-934-0095
- E-mail: karmstead@uabmc.edu
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35209
- Recrutement
- University of Alabama at Birmingham
-
Contact:
- Kimberly M. Armstead Clinical Research Coordinator III, B.S.
- Numéro de téléphone: 205-934-0095
- E-mail: karmstead@uabmc.edu
-
Contact:
- Rachel L Benz Clinical Research Nurse Manager, MSN
- Numéro de téléphone: 205-934-2184
- E-mail: rlbenz@uabmc.edu
-
Chercheur principal:
- Colm P. Travers, M.D.
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Documented episodes of apnea with bradycardia over the previous 24 hours.
- Off ventilatory support/NCPAP for > 48 hours prior to study entry
- Gestational age < 32 0/7 weeks' gestation at birth
- Parents/legal guardians have provided consent for enrollment
Exclusion Criteria:
- a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Virbrotactile stimulation
Four hours of vibrotactile stimulation via a closed loop device if an apnea or bradycardia episode is predicted or detected. |
Vibro-Tactile stimulation when bradycardia is predicted or predicted. |
|
Comparateur factice: Control
Four hours of no vibrotactile stimulation via the closed loop device if an apnea or bradycardia episode is predicted or detected. |
Sham closed-loop vibrotactile stimulator |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Bradycardia <100 beats per minute ≥ 10 seconds
Délai: 4-hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate less than 100 of ≥ 10 seconds) in either study arm during the study period. |
4-hours on either intervention.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Bradycardia <60 beats per minute ≥ 5 seconds
Délai: 4 hours in either intervention.
|
The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 5 seconds) in either study arm during the study period. |
4 hours in either intervention.
|
|
Bradycardia <60 beats per minute ≥ 10 seconds
Délai: 4 hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Bradycardia <80 beats per minute ≥ 5 seconds
Délai: 4 hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Bradycardia <80 beats per minute ≥ 10 seconds
Délai: 4 hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Proportion of time with Bradycardia < 100 beats per minute
Délai: 4 hours on either intervention.
|
The total proportion of time with bradycardia during the study period on either intervention with a heartrate of <100 beats per minute. |
4 hours on either intervention.
|
|
Hypoxemia <85% for ≥ 5 seconds
Délai: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <85% for ≥ 10 seconds
Délai: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <90% for ≥ 5 seconds
Délai: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <90% for ≥ 10 seconds
Délai: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <80% for ≥ 5 seconds
Délai: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <80% for ≥ 10 seconds
Délai: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Proportion of time with hypoxemia < 90%
Délai: 4 hours on either intervention.
|
The total proportion of time with oxygen saturations <90% during the study period on either intervention. |
4 hours on either intervention.
|
|
Bradycardia prediction time
Délai: 4 hours on either intervention.
|
The number of seconds ahead of routine patient monitors at which the device algorithm predicted bradycardia in either group. |
4 hours on either intervention.
|
|
Bradycardia prediction accuracy
Délai: 4 hours on sham control.
|
The area under the curve for the true prediction rate over the false alarm rate in the control group. |
4 hours on sham control.
|
|
Proportion of time with hypoxemia < 85%
Délai: 4 hours on either intervention.
|
The total proportion of time with oxygen saturations <85% during the study period on either intervention. |
4 hours on either intervention.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Colm P. Travers Associate Professor of Pediatrics, M.D., University of Alabama at Birmingham
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Autres numéros d'identification d'étude
- 300008477
- UAB (Autre identifiant: UAB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Deidentified individual participant data will be made available upon publication through a data use agreement to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to cptravers@uabmc.edu.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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