Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV) (NIPPV)
Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants
The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.
Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.
The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The immature lung of extremely low birth weight (ELBW, < 1000 g) infants is easily damaged by the placement of an endotracheal tube to deliver mechanical ventilation and oxygen. This and the total time of mechanical ventilation contributes to bronchopulmonary dysplasia (BPD). Infants with BPD have an increased risk of later death or neuro-impairment. With the increasing survival of ELBW infants in the NICU, there has been a proportionate increase in the number of infants surviving with BPD.
Following invasive ventilation via an endotracheal tube (ETT), extubation to nasal Continuous Positive Airway Pressure (nCPAP)ventilation is the standard approach. Currently, 40% of infants who are extubated and given nCPAP support fail, and require re-intubation. Previous work suggests that a less invasive respiratory support such as Nasal Intermittent Positive Pressure Ventilation (NIPPV), without an endotracheal tube is less injurious to the lung. NIPPV may thereby reduce the duration of invasive ventilator support, and aid successful early extubation. We hypothesize that the use of NIPPV leads to a higher rate of survival without BPD than standard therapy with nCPAP.
This randomized clinical trial is appropriately powered to compare NIPPV with nCPAP to detect effects on clinically relevant long-term outcomes, such as death and BPD at 36 weeks. This is a multi-national, randomized, open clinical trial of two different standard methods of providing non-invasive respiratory support to 1000 extremely preterm infants weighing less than 1000 grams at birth.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Feldkirch, Austria, 6800
- LKH Feldkirch
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Rocourt, Bélgica, B-4000
- CHC St. Vincent
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Manitoba
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Winnipeg, Manitoba, Canadá
- Winnipeg Health Sciences Centre
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Winnipeg, Manitoba, Canadá, R3E 0L8
- St. Boniface General Hospital/University of Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canadá
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canadá, L8S 4J9
- McMaster University
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Ottawa, Ontario, Canadá, K1H 8L1
- Children's Hospital of Eastern Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
- The Ottawa Hospital General Campus
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Toronto, Ontario, Canadá
- Hospital for Sick Children
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá
- Royal University Hospital
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20037
- The George Washington University Hospital
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Washington, District of Columbia, Estados Unidos, 20007
- Georgetown University Children's Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center (Bidmc)
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts University Medical Center
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New Jersey
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Voorhees, New Jersey, Estados Unidos, 08043
- Virtua West Jersey Hospital
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New York
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Brooklyn, New York, Estados Unidos, 11203
- Kings County Hospital
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Brooklyn, New York, Estados Unidos, 11023
- SUNY Downstate Medical Center
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Brooklyn, New York, Estados Unidos, 11355
- New York Hospital Queens
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Jamaica, New York, Estados Unidos, 11432
- Queens Hospital Center
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New York, New York, Estados Unidos, 11212
- Brookdale University Hospital & Medical Center
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Stony Brook, New York, Estados Unidos, 11794-8111
- Stony Brook University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Estados Unidos, 19035
- Pennsylvania Hospital/U. of Pennsylvania
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Utah
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Salt Lake City, Utah, Estados Unidos, 84158-1289
- University of Utah
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Dublin, Irlanda
- National Maternity Hospital
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Dublin, Irlanda
- Coombe Women's Hospital
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Cork
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Wilton, Cork, Irlanda
- Cork University Maternity Hospital
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Doha, Katar
- Hamad Medical Corporation
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Groningen, Países Bajos, 9700 RB
- University Medical Center Groningen/Beatrix Children's Hosp
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Zwolle, Países Bajos, 8000 GK
- Princess Amalia Dept of Pediatrics, Isala Clinics
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Leicester, Reino Unido, LE1 6TP
- University of Leicester
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London, Reino Unido, W2 1NY
- St. Mary's Hospital
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Northern Ireland
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Belfast, Northern Ireland, Reino Unido, BT12 6BB
- Royal Maternity Hospital
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Singapore, Singapur, 229899
- KK Women's and Children's Hospital
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Stockholm, Suecia, S-171 76
- Karolinska University Hospital/Astrid Lingrenn's Children's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Birth weight <1000 gm
- Gestational age <30 completed weeks
Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either:
- the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support;
- the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
Exclusion Criteria:
- Considered non-viable by clinician (decision not to administer effective therapies)
- Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- Infants known to require surgical treatment
- Abnormalities of the upper and lower airways
- Neuromuscular disorders
- Infants who are >28 days old and continue to require mechanical ventilation with an endotracheal tube
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: A
Non-invasive respiratory support via nasal intermittent positive pressure ventilation
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Deliver non-invasive respiratory support via ventilator with NIPPV device
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Comparador activo: B
Non-invasive respiratory support via nasal Continuous Positive Airway Pressure
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Deliver non-invasive respiratory support via ventilator with nCPAP device
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia
Periodo de tiempo: 36 weeks gestational age
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36 weeks gestational age
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Mortalidad por todas las causas a las 36 semanas de edad gestacional
Periodo de tiempo: 36 semanas de edad gestacional
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36 semanas de edad gestacional
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retinopatía del prematuro
Periodo de tiempo: alta domiciliaria
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alta domiciliaria
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All cause mortality before first discharge home
Periodo de tiempo: first discharge home
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first discharge home
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ultrasonographic evidence of brain injury
Periodo de tiempo: 36 weeks gestional age
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36 weeks gestional age
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necrotizing enterocolitis
Periodo de tiempo: 36 weeks gestational age
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36 weeks gestational age
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growth
Periodo de tiempo: discharge home
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discharge home
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time to establish full feeds
Periodo de tiempo: discharge home
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discharge home
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nosocomial infections
Periodo de tiempo: discharge home
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discharge home
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need for re-intubation
Periodo de tiempo: 36 weeks gestational age
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36 weeks gestational age
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time on supplemental oxygen
Periodo de tiempo: discharge home
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discharge home
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duration of positive pressure respiratory support
Periodo de tiempo: discharge home
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discharge home
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comparison of synchronized and non-synchronized NIPPV
Periodo de tiempo: discharge home
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discharge home
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bronchopulmonary dysplasia
Periodo de tiempo: 36 weeks gestational age
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36 weeks gestational age
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air leak syndromes
Periodo de tiempo: 36 weeks gestational age
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36 weeks gestational age
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nasal trauma
Periodo de tiempo: discharge home
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discharge home
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Haresh Kirpalani, MD, MSc, Hamilton Health Sciences Corporation
- Director de estudio: Brigitte Lemyre, MD, Children's Hospital of Eastern Ontario
- Director de estudio: Aaron Chiu, MD, St. Boniface Hospital
- Director de estudio: David Millar, MD, Royal Maternity Hospital, Belfast
- Director de estudio: Robin S Roberts, MTech, Hamilton Health Sciences/McMaster University
- Director de estudio: Bradley Yoder, MD, University of Utah
- Director de estudio: Peter H Dijk, MD, PhD, University Medical Centrum Groningen
Publicaciones y enlaces útiles
Publicaciones Generales
- Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug 15;369(7):611-20. doi: 10.1056/NEJMoa1214533.
- Bamat NA, Guevara JP, Bryan M, Roberts RS, Yoder BA, Lemyre B, Chiu A, Millar D, Kirpalani H. Variation in Positive End-Expiratory Pressure Levels for Mechanically Ventilated Extremely Low Birth Weight Infants. J Pediatr. 2018 Mar;194:28-33.e5. doi: 10.1016/j.jpeds.2017.10.065. Epub 2017 Dec 22.
- Millar D, Lemyre B, Kirpalani H, Chiu A, Yoder BA, Roberts RS. A comparison of bilevel and ventilator-delivered non-invasive respiratory support. Arch Dis Child Fetal Neonatal Ed. 2016 Jan;101(1):F21-5. doi: 10.1136/archdischild-2014-308123. Epub 2015 Jul 10.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Enfermedades pulmonares
- Infantil, Recién Nacido, Enfermedades
- Complicaciones del embarazo
- Complicaciones obstétricas del parto
- Trabajo de parto prematuro, obstétrico
- Lesión pulmonar
- Infantil, Prematuro, Enfermedades
- Lesión pulmonar inducida por ventilador
- Insuficiencia respiratoria
- Nacimiento prematuro
- Displasia broncopulmonar
Otros números de identificación del estudio
- NTG-2007-NIPPV
- CIHR MCT-80246
- ISRCTN15233270
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