A Phase 3 interventional study of nCPAP and NIPPV in Respiratory Insufficiency of Prematurity, sponsored by McMaster University. Completed at 35 sites in 10 countries. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2014-12-05.
Sponsored by McMaster University · Phase 3, Interventional, and Prevention
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?
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.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's enrollment of 1,011 is above the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either:
Exclusion Criteria:
Non-invasive respiratory support via nasal intermittent positive pressure ventilation
Device: NIPPV
Non-invasive respiratory support via nasal Continuous Positive Airway Pressure
Device: nCPAP
Deliver non-invasive respiratory support via ventilator with nCPAP device
Deliver non-invasive respiratory support via ventilator with NIPPV device
Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia
Time frame: 36 weeks gestational age
All cause mortality at 36 weeks gestational age
Time frame: 36 weeks gestational age
All cause mortality before first discharge home
Time frame: first discharge home
retinopathy of prematurity
Time frame: discharge home
ultrasonographic evidence of brain injury
Time frame: 36 weeks gestional age
necrotizing enterocolitis
Time frame: 36 weeks gestational age
growth
Time frame: discharge home
time to establish full feeds
Time frame: discharge home
nosocomial infections
Time frame: discharge home
need for re-intubation
Time frame: 36 weeks gestational age
time on supplemental oxygen
Time frame: discharge home
duration of positive pressure respiratory support
Time frame: discharge home
comparison of synchronized and non-synchronized NIPPV
Time frame: discharge home
bronchopulmonary dysplasia
Time frame: 36 weeks gestational age
air leak syndromes
Time frame: 36 weeks gestational age
nasal trauma
Time frame: discharge home
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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