Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)
- Conditions
- Respiratory Insufficiency of Prematurity
- Interventions
- Device: nCPAPDevice: NIPPV
- Registration Number
- NCT00433212
- Lead Sponsor
- McMaster University
- Brief Summary
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?
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1011
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B nCPAP Non-invasive respiratory support via nasal Continuous Positive Airway Pressure A NIPPV Non-invasive respiratory support via nasal intermittent positive pressure ventilation
- Primary Outcome Measures
Name Time Method Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia 36 weeks gestational age
- Secondary Outcome Measures
Name Time Method ultrasonographic evidence of brain injury 36 weeks gestional age All cause mortality at 36 weeks gestational age 36 weeks gestational age growth discharge home time to establish full feeds discharge home nosocomial infections discharge home All cause mortality before first discharge home first discharge home necrotizing enterocolitis 36 weeks gestational age air leak syndromes 36 weeks gestational age nasal trauma discharge home retinopathy of prematurity discharge home time on supplemental oxygen discharge home need for re-intubation 36 weeks gestational age duration of positive pressure respiratory support discharge home comparison of synchronized and non-synchronized NIPPV discharge home bronchopulmonary dysplasia 36 weeks gestational age
Trial Locations
- Locations (35)
University of Utah
🇺🇸Salt Lake City, Utah, United States
LKH Feldkirch
🇦🇹Feldkirch, Austria
CHC St. Vincent
🇧🇪Rocourt, Belgium
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
McMaster University
🇨🇦Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
The Ottawa Hospital General Campus
🇨🇦Ottawa, Ontario, Canada
Cork University Maternity Hospital
🇮🇪Wilton, Cork, Ireland
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Coombe Women's Hospital
🇮🇪Dublin, Ireland
National Maternity Hospital
🇮🇪Dublin, Ireland
University Medical Center Groningen/Beatrix Children's Hosp
🇳🇱Groningen, Netherlands
Princess Amalia Dept of Pediatrics, Isala Clinics
🇳🇱Zwolle, Netherlands
Hamad Medical Corporation
🇶🇦Doha, Qatar
KK Women's and Children's Hospital
🇸🇬Singapore, Singapore
Royal Maternity Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
University of Leicester
🇬🇧Leicester, United Kingdom
St. Mary's Hospital
🇬🇧London, United Kingdom
Karolinska University Hospital/Astrid Lingrenn's Children's Hospital
🇸🇪Stockholm, Sweden
Beth Israel Deaconess Medical Center (BIDMC)
🇺🇸Boston, Massachusetts, United States
Tufts University Medical Center
🇺🇸Boston, Massachusetts, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Virtua West Jersey Hospital
🇺🇸Voorhees, New Jersey, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Winnipeg Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
St. Boniface General Hospital/University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Georgetown University Children's Medical Center
🇺🇸Washington, District of Columbia, United States
The George Washington University Hospital
🇺🇸Washington, District of Columbia, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Kings County Hospital
🇺🇸Brooklyn, New York, United States
Pennsylvania Hospital/U. of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Queens Hospital Center
🇺🇸Jamaica, New York, United States
Brookdale University Hospital & Medical Center
🇺🇸New York, New York, United States
New York Hospital Queens
🇺🇸Brooklyn, New York, United States