Prematurity Clinical Trial
Official title:
Effect of Titrating Oxygen Concentration During Resuscitation of the Newborn on Achieving Normoxemia
Preterm infants are born with immature lungs and often require help with breathing shortly
after birth. This currently involves administering 100% oxygen. Unfortunately, delivery of
high oxygen concentrations leads to the production of free radicals that can injure many
organ systems. Term and near-term newborns deprived of oxygen during or prior to birth
respond as well or better to resuscitation with room air (21% oxygen) compared to 100%
oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm
infants with lung disease. Our study will investigate how adjusting the amount of oxygen
given to sick preterm newborns will affect the ability to maintain a safe oxygen level in
their blood. Each infant will be assigned to receive one of three treatments at birth.
Resuscitation will either start with 21% oxygen and be increased if needed, 100% oxygen and
be decreased if needed or 100% oxygen with no changes made (current standard of treatment).
The first two groups will have adjustments in oxygen concentration as needed to reach a safe
target range of blood oxygen saturation. We anticipate that preterm newborn infants
resuscitated with higher oxygen concentrations will have higher than "normal" levels of
oxygen in their blood while those resuscitated initially with lower concentrations of oxygen
will be more likely to have "normal" oxygen levels in their blood. All premature infants
will have a surface probe placed on the right hand to measure the saturation of blood with
oxygen. Following the resuscitation, treatment will proceed as per standard of care until
hospital discharge. All infants will be admitted to the neonatal intensive care unit given
their prematurity. The purpose of this study is to investigate how safely restricting the
amount of oxygen delivered to newborns during resuscitation will affect the amount of oxygen
in their blood.
Hypothesis: In this randomized control trial, infants resuscitated with a "low oxygen
delivery (LOD)" strategy (initiation of resuscitation with 21% O2) will remain normoxemic
for the greatest proportion of time during resuscitation and infants resuscitated with a
"high oxygen delivery (HOD)" strategy (100% O2 used for the entire resuscitation) will be
normoxemic for the smallest proportion of time during resuscitation.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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