Aplicação para prever apneia neonatal com bradicardia (APNeA)
Aplicação para prever a apneia neonatal com bradicardia (estudo da apnea)
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Rachel L. Benz, Clinical Research Nurse Manager, MSN
- Número de telefone: 205-934-2184
- E-mail: rlbenz@uabmc.edu
Estude backup de contato
- Nome: Kimberly M. Armstead Clinical Research Coordinator III, B.S.
- Número de telefone: 205-934-0095
- E-mail: karmstead@uabmc.edu
Locais de estudo
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-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35209
- Recrutamento
- University of Alabama at Birmingham
-
Contato:
- Kimberly M. Armstead Clinical Research Coordinator III, B.S.
- Número de telefone: 205-934-0095
- E-mail: karmstead@uabmc.edu
-
Contato:
- Rachel L Benz Clinical Research Nurse Manager, MSN
- Número de telefone: 205-934-2184
- E-mail: rlbenz@uabmc.edu
-
Investigador principal:
- Colm P. Travers, M.D.
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
|
Comparador Falso: 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Bradycardia <100 beats per minute ≥ 10 seconds
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Bradycardia <60 beats per minute ≥ 5 seconds
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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%
Prazo: 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
Prazo: 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
Prazo: 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%
Prazo: 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.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Colm P. Travers Associate Professor of Pediatrics, M.D., University of Alabama at Birmingham
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 300008477
- UAB (Outro identificador: UAB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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