None listed
Conditions
Brief summary
While positive end expiratory pressure (PEEP) is always used during intermittent positive pressure ventilation (IPPV), there are no current recommendations about the use of PEEP or continuous positive airway pressure (CPAP) during neonatal resusciation. The Neopuff is a manual ventilation device which delivers PEEP or CPAP. The Laerdal bag is the commonest manual ventilation device in use worldwide and does not deliver PEEP. Our hypothesis is that the delivery of PEEP or CPAP to very premature infants at birth may lead to a more rapid improvement in lung volume and therefore oxygenation.
Interventions
A randomised controlled trial of the Laerdal infant resuscitator (control) to provide positive pressure ventilation (in line with the Australian Resuscitation Council guidelines) during resuscitation of infants born at less than 29 weeks gestation. The duration of the trial is 18 months, we anticipate completing recruitment in August 2008.
Sponsors
Professor Colin J Morley
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
All infants born <29 weeks gestation in need of positive pressure ventilation, because of inadequate respiration and/or a heart rate of less than one hundred beats per minute (HR <100 bpm) will be eligible for resuscitation and therefore entry to this study.
Exclusion criteria
Infants will be excluded from final analysis if they have a condition that might have an adverse effect on breathing or ventilation apart from prematurity or asphyxia.
Outcome results
None listed