Respiratory Insufficiency of Prematurity Clinical Trial
Official title:
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?
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00636324 -
Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study)
|
Phase 2 | |
| Completed |
NCT00637169 -
Canadian Oxygen Trial (COT)
|
Phase 3 |