Extreme Prematurity - Less Than 28 Weeks Clinical Trial
Official title:
The Premature Infants Resuscitated With Oxygen or Air (PRESOX) Trial
The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.
The Premature Infants Resuscitated with Oxygen or Air (PRESOX) trial, is a prospective
randomized clinical trial of extremely premature infants that will assess the use of a low
and high oxygen concentration for the initial resuscitation. The hypothesis is that infants
resuscitated with a lower oxygen concentration at birth will have a increase in survival
without bronchopulmonary dysplasia (BPD) or retinopathy of prematurity (ROP) during their
initial hospitalization, and will have a increase in survival without neurodevelopmental
impairments.
Previous studies of mostly term newborn infants have demonstrated that initial resuscitation
with room air compared to 100% oxygen resulted in improved outcomes and an overall decrease
in mortality. The analysis of these studies demonstrated that the reduction in mortality was
very significant in the preterm infants that had been included in these trials. A number of
small clinical trials have now demonstrated that it is feasible to treat very preterm infants
with lower versus higher concentrations of oxygen while carefully monitoring their oxygen
saturation in the minutes following delivery. As review of the previous observations
demonstrated that there was a reduction in death using lower oxygen concentration, it is
imperative that a large study of preterm infants be conducted to determine if a lower
compared to a higher oxygen concentration for the initial resuscitation will lead to improved
short and longer term outcomes including survival without neurodevelopmental disability.
The PRESOX trial will randomize infants from 23 weeks gestation to 28 weeks gestation who
require resuscitation at birth to receive either room air or 60% oxygen. Oxygen saturation
will be monitored from the first minute of life and the initial oxygen concentration will be
titrated using a unique purpose built device which will track the oxygen saturation (SpO2)
within the chosen target limits. The targets chosen allow the infants oxygen saturation to
follow the increase seen in normal preterm infants who do not require resuscitation.
Following resuscitation the infants will be transferred to the Neonatal Intensive Care Unit
and management will follow the usual care in those units. In a subset of infants, levels of
antioxidants from the infant's blood and urine will be measured by Dr M Vento. This portion
of the study is already funded by the combined Spanish Ministries of Health and Science.
Antioxidants are known to increase with exposure to oxygen. The infants will return for a
neurodevelopmental follow up examination at the age of two years.
This trial will provide urgently needed evidence to establish the most optimal care to these
very fragile preterm infants.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02200900 -
Study of Respiratory Physiology During High Flow Nasal Cannula Treatment in Preterm Neonates.
|
N/A |