Maki trial
Effect of palivizumab in the development of repeated episodes of wheezing in children born with a gestational age of 32-35 weeks
population uitklapper, klik om te openen
In this study we look at healthy children born after a gestation of 32-35 weeks. Eventually, 450 children will be treated. For this study UMC Utrecht works in collaboration with the following Dutch hospitals :
• Diakonessen Hospital (Utrecht)
• Gelre Hospitals (Apeldoorn)
• Zuwe Hofpoort hospital (Woerden)
• Meander Medical Center (Amersfoort)
• Mesos Medical Centre (Utrecht)
• St. Antonius Hospital (Nieuwegein)
• Hospital Gelderland Valley (Ede)
• Deventer Hospital (Deventer)
• Maxima Medical Center (Veldhoven)
• Catharina Hospital (Eindhoven)
• Albert Schweitzer Hospital (Dordrecht)
• Ikazia Hospital (Rotterdam)
• Tergooi Hospitals (Blaricum)
• Beatrix Hospital (Gorinchem)
• Hospital Rivierenland (Tiel)
• St. Jansdal Hospital (Harderwijk)
population uitklapper, klik om te openen
In this study we look at healthy children born after a gestation of 32-35 weeks. Eventually, 450 children will be treated. For this study UMC Utrecht works in collaboration with the following Dutch hospitals :
• Diakonessen Hospital (Utrecht)
• Gelre Hospitals (Apeldoorn)
• Zuwe Hofpoort hospital (Woerden)
• Meander Medical Center (Amersfoort)
• Mesos Medical Centre (Utrecht)
• St. Antonius Hospital (Nieuwegein)
• Hospital Gelderland Valley (Ede)
• Deventer Hospital (Deventer)
• Maxima Medical Center (Veldhoven)
• Catharina Hospital (Eindhoven)
• Albert Schweitzer Hospital (Dordrecht)
• Ikazia Hospital (Rotterdam)
• Tergooi Hospitals (Blaricum)
• Beatrix Hospital (Gorinchem)
• Hospital Rivierenland (Tiel)
• St. Jansdal Hospital (Harderwijk)
Intervention: uitklapper, klik om te openen
All children involved in the study will receive during the winter months monthly- by injection into the thigh- palivizumab ( 15 mg / kg ) or placebo . The distribution is determined by randomization. This is a double-blind study.
aim of the study uitklapper, klik om te openen
With this study we want to determine whether prevention of RSV infection in children born with a gestational age 32-35 weeks by monthly administration of palivizumab in winter can also prevent recurrent episodes of wheezing.
Intervention: uitklapper, klik om te openen
All children involved in the study will receive during the winter months monthly- by injection into the thigh- palivizumab ( 15 mg / kg ) or placebo . The distribution is determined by randomization. This is a double-blind study.
aim of the study uitklapper, klik om te openen
With this study we want to determine whether prevention of RSV infection in children born with a gestational age 32-35 weeks by monthly administration of palivizumab in winter can also prevent recurrent episodes of wheezing.
Inclusion uitklapper, klik om te openen
The inclusion period was from August 2008 to December 2010 .
Inclusion criteria:
• gestational age of 32-35 weeks
• age at the start of the RSV season (October 1 ) less than 6 months
• parents sufficiently fluent in the Dutch language
exclusion criteria :
• children familiar with a heart defect , Down syndrome or other severe congenital anomalies
• respiratory symptoms requiring treatment before the start of the RSV season
• respiratory symptoms of wheezing before the start of the RSV season
Inclusion uitklapper, klik om te openen
The inclusion period was from August 2008 to December 2010 .
Inclusion criteria:
• gestational age of 32-35 weeks
• age at the start of the RSV season (October 1 ) less than 6 months
• parents sufficiently fluent in the Dutch language
exclusion criteria :
• children familiar with a heart defect , Down syndrome or other severe congenital anomalies
• respiratory symptoms requiring treatment before the start of the RSV season
• respiratory symptoms of wheezing before the start of the RSV season
Outcome Measure uitklapper, klik om te openen
The primary outcome measure is the number of days with wheezing during the first year of life, noted by parents in a diary. In addition, parents make a swab from the nose and throat when children present with respiratory symptoms, and in the case of severe colds. The parents then contact the study investigators so that the nasal mucus maybe tested for the presence of RSV.
Secondary outcome measures are; the number of episodes of wheezing in later life, measured by questionnaires at the ages of 3 and 6 years; health-related/ quality of life questionnaires conducted during the first year of the child; and through assessment of the socio - economic impact of RSV and recurrent episodes of wheezing, defined as the cost of medications, doctor visits, hospitalizations, and indirectly as parental absenteeism from work. At age 6 lung function and asthma will be measured.
Outcome Measure uitklapper, klik om te openen
The primary outcome measure is the number of days with wheezing during the first year of life, noted by parents in a diary. In addition, parents make a swab from the nose and throat when children present with respiratory symptoms, and in the case of severe colds. The parents then contact the study investigators so that the nasal mucus maybe tested for the presence of RSV.
Secondary outcome measures are; the number of episodes of wheezing in later life, measured by questionnaires at the ages of 3 and 6 years; health-related/ quality of life questionnaires conducted during the first year of the child; and through assessment of the socio - economic impact of RSV and recurrent episodes of wheezing, defined as the cost of medications, doctor visits, hospitalizations, and indirectly as parental absenteeism from work. At age 6 lung function and asthma will be measured.
Study report uitklapper, klik om te openen
“First year wheezing” results of MAKI have been published (Blanken, N Engl J Med 2013)
Expected publication of lung function and asthma results: 2018
“First year wheezing” results of MAKI have been published (Blanken, N Engl J Med 2013)
Expected publication of lung function and asthma results: 2018
“First year wheezing” results of MAKI have been published (Blanken, N Engl J Med 2013)
Expected publication of lung function and asthma results: 2018
“First year wheezing” results of MAKI have been published (Blanken, N Engl J Med 2013)
Expected publication of lung function and asthma results: 2018
background uitklapper, klik om te openen
Preterm infants have an increased risk of being hospitalized due to RSV infection. During the first year of life in children born with a gestational age of 32-35 weeks, the risk is 3-6 %. Palivizumab (Synagis brand name) has been shown to prevent RSV infection in children with these risk factors. Palivizumab is an antibody against RSV. With monthly administration (passive immunization) during the winter months, we saw a reduction of hospital admissions due to RSV infection by 55%. However, it is uncertain whether this will also prevent recurrent episodes of wheezing. This is especially important in preterm children because they have increased risk of chronic airway disease.
Preterm infants have an increased risk of being hospitalized due to RSV infection. During the first year of life in children born with a gestational age of 32-35 weeks, the risk is 3-6 %. Palivizumab (Synagis brand name) has been shown to prevent RSV infection in children with these risk factors. Palivizumab is an antibody against RSV. With monthly administration (passive immunization) during the winter months, we saw a reduction of hospital admissions due to RSV infection by 55%. However, it is uncertain whether this will also prevent recurrent episodes of wheezing. This is especially important in preterm children because they have increased risk of chronic airway disease.
Preterm infants have an increased risk of being hospitalized due to RSV infection. During the first year of life in children born with a gestational age of 32-35 weeks, the risk is 3-6 %. Palivizumab (Synagis brand name) has been shown to prevent RSV infection in children with these risk factors. Palivizumab is an antibody against RSV. With monthly administration (passive immunization) during the winter months, we saw a reduction of hospital admissions due to RSV infection by 55%. However, it is uncertain whether this will also prevent recurrent episodes of wheezing. This is especially important in preterm children because they have increased risk of chronic airway disease.
Preterm infants have an increased risk of being hospitalized due to RSV infection. During the first year of life in children born with a gestational age of 32-35 weeks, the risk is 3-6 %. Palivizumab (Synagis brand name) has been shown to prevent RSV infection in children with these risk factors. Palivizumab is an antibody against RSV. With monthly administration (passive immunization) during the winter months, we saw a reduction of hospital admissions due to RSV infection by 55%. However, it is uncertain whether this will also prevent recurrent episodes of wheezing. This is especially important in preterm children because they have increased risk of chronic airway disease.
Commonly children are infected with respiratory syncytial virus (RSV) within the first two years of life. This usually takes the form of a mild respiratory infection. Nevertheless, in 1500 to 2000 children, many are admitted to Dutch hospitals for RSV bronchiolitis, which is an inflammation of the lower airways. About 10 % of children admitted with RSV infections will be ventilated in an ICU. Mortality due to RSV infection is fortunately rare. There is currently no treatment for RSV infections.
Important for this study is that in about 50 % of the children (which are included with RSV infection) will develop recurrent episodes of wheezing. It is not possible to predict which children's respiratory symptoms develop after RSV infection.
Commonly children are infected with respiratory syncytial virus (RSV) within the first two years of life. This usually takes the form of a mild respiratory infection. Nevertheless, in 1500 to 2000 children, many are admitted to Dutch hospitals for RSV bronchiolitis, which is an inflammation of the lower airways. About 10 % of children admitted with RSV infections will be ventilated in an ICU. Mortality due to RSV infection is fortunately rare. There is currently no treatment for RSV infections.
Important for this study is that in about 50 % of the children (which are included with RSV infection) will develop recurrent episodes of wheezing. It is not possible to predict which children's respiratory symptoms develop after RSV infection.
Commonly children are infected with respiratory syncytial virus (RSV) within the first two years of life. This usually takes the form of a mild respiratory infection. Nevertheless, in 1500 to 2000 children, many are admitted to Dutch hospitals for RSV bronchiolitis, which is an inflammation of the lower airways. About 10 % of children admitted with RSV infections will be ventilated in an ICU. Mortality due to RSV infection is fortunately rare. There is currently no treatment for RSV infections.
Important for this study is that in about 50 % of the children (which are included with RSV infection) will develop recurrent episodes of wheezing. It is not possible to predict which children's respiratory symptoms develop after RSV infection.
Commonly children are infected with respiratory syncytial virus (RSV) within the first two years of life. This usually takes the form of a mild respiratory infection. Nevertheless, in 1500 to 2000 children, many are admitted to Dutch hospitals for RSV bronchiolitis, which is an inflammation of the lower airways. About 10 % of children admitted with RSV infections will be ventilated in an ICU. Mortality due to RSV infection is fortunately rare. There is currently no treatment for RSV infections.
Important for this study is that in about 50 % of the children (which are included with RSV infection) will develop recurrent episodes of wheezing. It is not possible to predict which children's respiratory symptoms develop after RSV infection.
Intervention: uitklapper, klik om te openen
All children involved in the study will receive during the winter months monthly- by injection into the thigh- palivizumab ( 15 mg / kg ) or placebo . The distribution is determined by randomization. This is a double-blind study.
aim of the study uitklapper, klik om te openen
With this study we want to determine whether prevention of RSV infection in children born with a gestational age 32-35 weeks by monthly administration of palivizumab in winter can also prevent recurrent episodes of wheezing.
aim of the study uitklapper, klik om te openen
With this study we want to determine whether prevention of RSV infection in children born with a gestational age 32-35 weeks by monthly administration of palivizumab in winter can also prevent recurrent episodes of wheezing.
Intervention: uitklapper, klik om te openen
All children involved in the study will receive during the winter months monthly- by injection into the thigh- palivizumab ( 15 mg / kg ) or placebo . The distribution is determined by randomization. This is a double-blind study.
population uitklapper, klik om te openen
In this study we look at healthy children born after a gestation of 32-35 weeks. Eventually, 450 children will be treated. For this study UMC Utrecht works in collaboration with the following Dutch hospitals :
• Diakonessen Hospital (Utrecht)
• Gelre Hospitals (Apeldoorn)
• Zuwe Hofpoort hospital (Woerden)
• Meander Medical Center (Amersfoort)
• Mesos Medical Centre (Utrecht)
• St. Antonius Hospital (Nieuwegein)
• Hospital Gelderland Valley (Ede)
• Deventer Hospital (Deventer)
• Maxima Medical Center (Veldhoven)
• Catharina Hospital (Eindhoven)
• Albert Schweitzer Hospital (Dordrecht)
• Ikazia Hospital (Rotterdam)
• Tergooi Hospitals (Blaricum)
• Beatrix Hospital (Gorinchem)
• Hospital Rivierenland (Tiel)
• St. Jansdal Hospital (Harderwijk)
population uitklapper, klik om te openen
In this study we look at healthy children born after a gestation of 32-35 weeks. Eventually, 450 children will be treated. For this study UMC Utrecht works in collaboration with the following Dutch hospitals :
• Diakonessen Hospital (Utrecht)
• Gelre Hospitals (Apeldoorn)
• Zuwe Hofpoort hospital (Woerden)
• Meander Medical Center (Amersfoort)
• Mesos Medical Centre (Utrecht)
• St. Antonius Hospital (Nieuwegein)
• Hospital Gelderland Valley (Ede)
• Deventer Hospital (Deventer)
• Maxima Medical Center (Veldhoven)
• Catharina Hospital (Eindhoven)
• Albert Schweitzer Hospital (Dordrecht)
• Ikazia Hospital (Rotterdam)
• Tergooi Hospitals (Blaricum)
• Beatrix Hospital (Gorinchem)
• Hospital Rivierenland (Tiel)
• St. Jansdal Hospital (Harderwijk)
Outcome Measure uitklapper, klik om te openen
The primary outcome measure is the number of days with wheezing during the first year of life, noted by parents in a diary. In addition, parents make a swab from the nose and throat when children present with respiratory symptoms, and in the case of severe colds. The parents then contact the study investigators so that the nasal mucus maybe tested for the presence of RSV.
Secondary outcome measures are; the number of episodes of wheezing in later life, measured by questionnaires at the ages of 3 and 6 years; health-related/ quality of life questionnaires conducted during the first year of the child; and through assessment of the socio - economic impact of RSV and recurrent episodes of wheezing, defined as the cost of medications, doctor visits, hospitalizations, and indirectly as parental absenteeism from work. At age 6 lung function and asthma will be measured.
Outcome Measure uitklapper, klik om te openen
The primary outcome measure is the number of days with wheezing during the first year of life, noted by parents in a diary. In addition, parents make a swab from the nose and throat when children present with respiratory symptoms, and in the case of severe colds. The parents then contact the study investigators so that the nasal mucus maybe tested for the presence of RSV.
Secondary outcome measures are; the number of episodes of wheezing in later life, measured by questionnaires at the ages of 3 and 6 years; health-related/ quality of life questionnaires conducted during the first year of the child; and through assessment of the socio - economic impact of RSV and recurrent episodes of wheezing, defined as the cost of medications, doctor visits, hospitalizations, and indirectly as parental absenteeism from work. At age 6 lung function and asthma will be measured.
Inclusion uitklapper, klik om te openen
The inclusion period was from August 2008 to December 2010 .
Inclusion criteria:
• gestational age of 32-35 weeks
• age at the start of the RSV season (October 1 ) less than 6 months
• parents sufficiently fluent in the Dutch language
exclusion criteria :
• children familiar with a heart defect , Down syndrome or other severe congenital anomalies
• respiratory symptoms requiring treatment before the start of the RSV season
• respiratory symptoms of wheezing before the start of the RSV season
Inclusion uitklapper, klik om te openen
The inclusion period was from August 2008 to December 2010 .
Inclusion criteria:
• gestational age of 32-35 weeks
• age at the start of the RSV season (October 1 ) less than 6 months
• parents sufficiently fluent in the Dutch language
exclusion criteria :
• children familiar with a heart defect , Down syndrome or other severe congenital anomalies
• respiratory symptoms requiring treatment before the start of the RSV season
• respiratory symptoms of wheezing before the start of the RSV season
Study report uitklapper, klik om te openen
“First year wheezing” results of MAKI have been published (Blanken, N Engl J Med 2013)
Expected publication of lung function and asthma results: 2018
“First year wheezing” results of MAKI have been published (Blanken, N Engl J Med 2013)
Expected publication of lung function and asthma results: 2018
“First year wheezing” results of MAKI have been published (Blanken, N Engl J Med 2013)
Expected publication of lung function and asthma results: 2018
“First year wheezing” results of MAKI have been published (Blanken, N Engl J Med 2013)
Expected publication of lung function and asthma results: 2018
background uitklapper, klik om te openen
Commonly children are infected with respiratory syncytial virus (RSV) within the first two years of life. This usually takes the form of a mild respiratory infection. Nevertheless, in 1500 to 2000 children, many are admitted to Dutch hospitals for RSV bronchiolitis, which is an inflammation of the lower airways. About 10 % of children admitted with RSV infections will be ventilated in an ICU. Mortality due to RSV infection is fortunately rare. There is currently no treatment for RSV infections.
Important for this study is that in about 50 % of the children (which are included with RSV infection) will develop recurrent episodes of wheezing. It is not possible to predict which children's respiratory symptoms develop after RSV infection.
Commonly children are infected with respiratory syncytial virus (RSV) within the first two years of life. This usually takes the form of a mild respiratory infection. Nevertheless, in 1500 to 2000 children, many are admitted to Dutch hospitals for RSV bronchiolitis, which is an inflammation of the lower airways. About 10 % of children admitted with RSV infections will be ventilated in an ICU. Mortality due to RSV infection is fortunately rare. There is currently no treatment for RSV infections.
Important for this study is that in about 50 % of the children (which are included with RSV infection) will develop recurrent episodes of wheezing. It is not possible to predict which children's respiratory symptoms develop after RSV infection.
Preterm infants have an increased risk of being hospitalized due to RSV infection. During the first year of life in children born with a gestational age of 32-35 weeks, the risk is 3-6 %. Palivizumab (Synagis brand name) has been shown to prevent RSV infection in children with these risk factors. Palivizumab is an antibody against RSV. With monthly administration (passive immunization) during the winter months, we saw a reduction of hospital admissions due to RSV infection by 55%. However, it is uncertain whether this will also prevent recurrent episodes of wheezing. This is especially important in preterm children because they have increased risk of chronic airway disease.
Preterm infants have an increased risk of being hospitalized due to RSV infection. During the first year of life in children born with a gestational age of 32-35 weeks, the risk is 3-6 %. Palivizumab (Synagis brand name) has been shown to prevent RSV infection in children with these risk factors. Palivizumab is an antibody against RSV. With monthly administration (passive immunization) during the winter months, we saw a reduction of hospital admissions due to RSV infection by 55%. However, it is uncertain whether this will also prevent recurrent episodes of wheezing. This is especially important in preterm children because they have increased risk of chronic airway disease.
Preterm infants have an increased risk of being hospitalized due to RSV infection. During the first year of life in children born with a gestational age of 32-35 weeks, the risk is 3-6 %. Palivizumab (Synagis brand name) has been shown to prevent RSV infection in children with these risk factors. Palivizumab is an antibody against RSV. With monthly administration (passive immunization) during the winter months, we saw a reduction of hospital admissions due to RSV infection by 55%. However, it is uncertain whether this will also prevent recurrent episodes of wheezing. This is especially important in preterm children because they have increased risk of chronic airway disease.
Preterm infants have an increased risk of being hospitalized due to RSV infection. During the first year of life in children born with a gestational age of 32-35 weeks, the risk is 3-6 %. Palivizumab (Synagis brand name) has been shown to prevent RSV infection in children with these risk factors. Palivizumab is an antibody against RSV. With monthly administration (passive immunization) during the winter months, we saw a reduction of hospital admissions due to RSV infection by 55%. However, it is uncertain whether this will also prevent recurrent episodes of wheezing. This is especially important in preterm children because they have increased risk of chronic airway disease.
Commonly children are infected with respiratory syncytial virus (RSV) within the first two years of life. This usually takes the form of a mild respiratory infection. Nevertheless, in 1500 to 2000 children, many are admitted to Dutch hospitals for RSV bronchiolitis, which is an inflammation of the lower airways. About 10 % of children admitted with RSV infections will be ventilated in an ICU. Mortality due to RSV infection is fortunately rare. There is currently no treatment for RSV infections.
Important for this study is that in about 50 % of the children (which are included with RSV infection) will develop recurrent episodes of wheezing. It is not possible to predict which children's respiratory symptoms develop after RSV infection.
Commonly children are infected with respiratory syncytial virus (RSV) within the first two years of life. This usually takes the form of a mild respiratory infection. Nevertheless, in 1500 to 2000 children, many are admitted to Dutch hospitals for RSV bronchiolitis, which is an inflammation of the lower airways. About 10 % of children admitted with RSV infections will be ventilated in an ICU. Mortality due to RSV infection is fortunately rare. There is currently no treatment for RSV infections.
Important for this study is that in about 50 % of the children (which are included with RSV infection) will develop recurrent episodes of wheezing. It is not possible to predict which children's respiratory symptoms develop after RSV infection.