This study is designed to answer one of the fundamental gaps in knowledge in the resuscitation of preterm infants at birth: What is the optimal target oxygen saturation (SpO2) range that increases survival without long-term morbidities? Oxygen (O2) is routinely used for the stabilization of preterm infants in the delivery room (DR), but its use is linked with mortality and several morbidities including bronchopulmonary dysplasia (BPD). To balance the need to give sufficient O2 to correct hypoxia and avoid excess O2, the neonatal resuscitation program (NRP) recommends initiating preterm resuscitation with low (≤ 30%) inspired O2 concentration (FiO2) and subsequent titration to achieve a specified target SpO2 range. These SpO2 targets are based on approximated 50th percentile SpO2 (Sat50) observed in healthy term infants. However, the optimal SpO2 targets remain undefined in the preterm infants. Recent data suggest that the current SpO2 targets (Sat50) may be too low. The investigators plan to conduct a multicenter RCT of Sat75 versus Sat50 powered for survival without BPD. The investigators will randomize 700 infants, 23 0/7- 30 6/7 weeks' GA, to 75th percentile SpO2 goals (Sat75, Intervention) or 50th percentile SpO2 goals (Sat50, control). Except for the SpO2 targets, all resuscitations will follow NRP guidelines including an initial FiO2 of 0.3. In Aim 1, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without lung disease (BPD). In addition, the investigators will compare the rates of other major morbidities such as IVH. In Aim 2, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without neurodevelopmental impairment at 2 years of age. In Aim 3, the investigators will determine whether targeting Sat75 compared to Sat50 decreases oxidative stress.
None
Prenatally diagnosed cyanotic congenital heart disease
Prenatally diagnosed congenital diaphragmatic hernia
Parents request no resuscitation
If preductal saturations can not be measured by 3 minutes after pulse oximeter sensor is applied to the newborn
Parallel
Sat75
Other interventionAs per the current NRP guidelines, resuscitation will be initiated with 0.3 FiO2. FiO2 will be titrated every 30 seconds by 0.2-0.3 to achieve target SpO2 that approximates the 75th percentile SpO2 observed in healthy term newborns. Percentiles are roughly based on Dawson reference curves of healthy term infants after birth. Apart from the randomly assigned target SpO2, resuscitation will follow the current NRP guidelines. Following NICU admission, all care decisions, including ventilator management, will be at the discretion of the clinical team.
Sat50
Other interventionAs per the current NRP guidelines, resuscitation will be initiated with 0.3 FiO2. FiO2 will be titrated every 30 seconds by 0.1-0.2 to achieve target SpO2 that approximates the 50th percentile SpO2 observed in healthy term newborns. Percentiles are roughly based on Dawson reference curves of healthy term infants after birth. Apart from the randomly assigned target SpO2, resuscitation will follow the current NRP guidelines. Following NICU admission, all care decisions, including ventilator management, will be at the discretion of the clinical team.
Survival without BPD
The primary outcome for this trial is survival without BPD at 36 weeks' PMA. Both components, death and BPD, will also be reported separately. Neonatal mortality during the NICU stay, the postnatal day at the time of mortality and the primary cause of mortality will be recorded. BPD will be defined as the need for any form of positive airway pressure support or supplemental O2 at 36 weeks' PMA.BPD will be graded as mild, moderate and severe as per the NICHD consensus definition. All eligible infants will undergo room air challenge at 36 weeks' PMA for the physiologic definition of BPD.
Bronchopulmonary Dysplasia
BPD will be defined as the need for any form of positive airway pressure support or supplemental O2 at 36 weeks' PMA.BPD will be graded as mild, moderate and severe as per the NICHD consensus definition. All eligible infants will undergo room air challenge at 36 weeks' PMA for the physiologic definition of BPD. In addition, BPD by Jensen Criteria will also be used as a secondary outcome. Respiratory support at 40 weeks PMA and at discharge will also be collected
Oxygen saturations in the delivery room
High resolution SpO2 data with 2 second frequency from pulse oximeter will be collected. Average Spo2 value every 30 seconds will be plotted. The investigators will also calculate time spent in the desired target, above the target or below the target.
SpO2<80% at 5 minutes after birth
SpO2\<80% at 5 minutes after birth
Delivery Room Intubation
The investigators will record if the newborn was intubated in the delivery room
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
University of Alabama at Birmingham
Collaborator
University of Oklahoma
Collaborator
North Central Baptist Hospital
Collaborator
Sharp Mary Birch Hospital for Women & Newborns
Collaborator
The Woman's Hospital of Texas
Collaborator
Baylor College of Medicine
Collaborator
University of Florida Health
Collaborator
University of Pittsburgh Medical Center
Collaborator
University of Pittsburgh
Collaborator
University of Utah
Collaborator
Primary Children's Hospital
Collaborator
Methodist Children's Hospital
Collaborator
