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Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS (ECALMIST)

18 de junho de 2013 atualizado por: Yahya Al Ethawi, University of Manitoba

Feasibility of Using Early CPAP (Continuous Positive Airway Pressure) And Large Volume Minimal Invasive Surfactant Therapy (ECALMIST) in Preterm Infants With Respiratory Distress Syndrome (RDS)

Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant). This modification is needed to adapt the use of large volume surfactant of 4-5 ml/kg.

The ECALMIST will be used to deliver the large volume Surfactant that been used in Canada called BLES (about 5 ml for each 100 mg) to the preterm infants bellow 35 weeks gestation suffer from respiratory distress syndrome (RDS) in 1st 24 hours of life while maintained on CPAP.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The 5 ml/Kg surfactant is warm to room temperature. Using standard laryngoscope without premedication while the infant is maintained on continuous positive airway pressure (CPAP. The the laryngoscope should be removed after stabilizing the vascular catheter between 2 fingers at the level of lips (weight +6 cm). The surfactant will be administer by boluses of 0.25 -0.5 ml at a time over 20-30 seconds and 10 seconds apart while maintain the vital signs.

The procedure should be stopped if the vital signs deteriorate, CPAP pressure and oxygen requirement might need to adjusted to restore baseline vital signs. If the vital signs remained unstable the catheter should be removed and the infant managed according by positive pressure ventilation (PPV) or intubation by endotracheal tube (ETT).

At the end of the procedure the catheter should be flushed with 0.5 ml of air then catheter should be removed.

FiO2 (fraction of inspired oxygen), oxygen saturation and CPAP pressure will be recorded before during and after the procedure.

Complication like bradycardia (Hear rate below 100 beat per minute) or Apnea (pause of respiration for more than 20 second or less than 20 seconds but associated with bradycardia) All other neonatal outcome will be recorded (IVH [Intra-ventricular Hemorrhage], ROP [Retinopathy of prematurity], duration of ventilation, duration of hospital stay, infection, duration of oxygen requirement and others.

Tipo de estudo

Intervencional

Inscrição (Real)

21

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Canadá
    • Manitoba
      • Winnipeg, Manitoba, Canadá
        • St. Boniface Hospital
      • Winnipeg, Manitoba, Canadá, R3C0L8
        • Children hospital of health Sciences Center
      • Winnipeg, Manitoba, Canadá, R3C0L8
        • Women's Hospital Health Science Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

10 minutos a 1 dia (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

-preterm infants less than 35 weeks gestation in 1st day of life with RDS and spontaneously breathing on CPAP and need surfactant administration.

Exclusion Criteria:

  • Infants needs of mechanical ventilation
  • Congenital anomaly
  • Respiratory distress due to non RDS related causes.
  • no parental consent

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: ECALMIST
Large volume 5ml/kg surfactant administered by vascular catheter while maintaining CPAP or ECALMIST; Early CPAP (continuous positive airway pressure) And Large volume Minimal Invasive Surfactant Therapy
Dispositivo: ECALMIST
Labelled catheter at level of the lips (6 cm plus weight) will inserted through the vocal cords under direct vision using a standard laryngoscope without premedication while maintaining CPAP. 5 ml/kg surfactant syringe will be connected to the catheter hub and 0.25-0.5 ml was administered; then the syringe will be disconnected from the catheter to observe the surfactant moving up and down or coming back as indication of accurate intubation of the trachea. The surfactant the slowly administer by boluses of 0.25-0.5 ml over 20-30 seconds with 10 seconds apart. At the end of the procedure, the operator flushed the catheter with 0.5 ml of air before removing the catheter while maintaining CPAP
Outros nomes:
  • Surfactant administration by catheter
Dispositivo: ECALMIST
Vascular catheter of 1.6 French size of 133 mm length 16 gauge used to deliver the BLES; a large volume surfactant while maintain CPAP
Outros nomes:
  • Surfactant administration by catheter

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence of Early Ventilation Hours
Prazo: 72 hours
The need for mechanical ventilation due to various reasons like sepsis, Apnea (pause of respiration for more than 20 seconds) or Respiratory dysfunction evidenced by abnormal blood gas or desaturation or increase work of breathing
72 hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Incidence of Bradycardia During Procedure
Prazo: Range of 10 minutes
Bradycardia is persistent heart rate below 100 beat per minute for more than 20 seconds during the procedure as seen by the monitor or Heart rate below 60 beat per minute for any time if chest compression is needed or if associated with desaturation or apnea.
Range of 10 minutes
Saturation During the Procedure
Prazo: 10 minutes
Level of oxygen which is measured by oxygen pulse Oximetry. It is express as proportion out of one which is equal to percentage of 100. The number can be anywhere between 0.21 to 1 which is equal to percentage of 21 to 100.
10 minutes
Failure to Catheterized the Trachea by the Vascular Catheter
Prazo: 20 seconds
Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.
20 seconds
Index Before the Procedure
Prazo: 1 hour

The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.

FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure.
1 hour
CPAP Pressure After the Procedure
Prazo: 4 hours
Continuous positive airway pressure (CPAP) is measured in centimeter of water
4 hours
Oxygen Requirement Before the Procedure
Prazo: 1 hour
Oxygen requirement or FiO2 (Fraction of inspired oxygen) is expressed as proportion out of one (decimal) or percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.
1 hour
Oxygen Saturation After the Procedure
Prazo: 4 hours
Oxygen saturation is measured by pulse oximetry. It is express as proportion out of 1 (decimal) that is equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.
4 hours
Index After the Procedure
Prazo: 4 hours

The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.

FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure.
4 hours
CPAP Pressure Before the Proceudre
Prazo: 1 hour
Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)
1 hour
Oxygen Saturation Before the Procedure
Prazo: 1 hour
Oxygen saturation is measured by pulse oximetry and express as proportion out of one which equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.
1 hour
Oxygen Requirements After the Procedure
Prazo: 4 hours
Oxygen requirement is expressed as proportion out of one (decimal) which is equal to percentage of 100. The measurment can be any where between 0.21 to 1 and this equal to percentage of 21-100%.
4 hours
Needs for Intubation During the Procedure
Prazo: 10 minutes
The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)
10 minutes

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Manitoba

Investigadores

  • Investigador principal: Yahya Al Ethawi, MD, University of Manitoba

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de abril de 2012

Conclusão Primária (Real)

1 de setembro de 2012

Conclusão do estudo (Real)

1 de setembro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

6 de março de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de março de 2012

Primeira postagem (Estimativa)

14 de março de 2012

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

24 de julho de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de junho de 2013

Última verificação

1 de junho de 2013

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • B2012:016

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