Bronchopulmonary Dysplasia Clinical Trial
— OptiSTARTOfficial title:
Optimization of Saturation Targets And Resuscitation (OptiSTART): Multicenter Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | April 1, 2029 |
Est. primary completion date | April 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Minutes to 10 Minutes |
Eligibility | Inclusion Criteria: -Neonates with OB gestational age 22-30 weeks Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | University of Alabama at Birmingham, University of Oklahoma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 36 weeks Postmenstrual Age | |
Secondary | 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 | 36 weeks PMA, 40 weeks PMA and at Discharge | |
Secondary | 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. | First 15 minutes after birth | |
Secondary | SpO2<80% at 5 minutes after birth | SpO2<80% at 5 minutes after birth | First 5 minutes after birth | |
Secondary | Delivery Room Intubation | The investigators will record if the newborn was intubated in the delivery room | Up to first 30 minutes after birth | |
Secondary | Receipt of chest compressions and epinephrine | In the rare event of the need for full CPR, data will be abstracted from the DR code documentation. FiO2 will be adjusted to 1.0 until return of spontaneous circulation and then titrated to achieve the randomized target SpO2. | Up to first 30 minutes after birth | |
Secondary | Severe Intraventricular hemorrhage | Severe Intraventricular hemorrhage | From date of randomization until the date of first documented diagnosis or date of death from any cause or date of discharge, whichever came first, assessed up to 12 months | |
Secondary | Severe Retinopathy of Prematurity | Severe Retinopathy of Prematurity | From date of randomization until the date of first documented diagnosis or date of death from any cause or date of discharge, whichever came first, assessed up to 12 months | |
Secondary | Length of hospitalization | Length of hospitalization | From date of randomization until the date of first documented diagnosis or date of death from any cause or date of discharge, whichever came first, assessed up to 12 months | |
Secondary | Necrotizing Enterocolitis (NEC) | Necrotizing enterocolitis will be defined = Stage 2 based on the modified Bell criteria. | From date of randomization until the date of first documented diagnosis or date of death from any cause or date of discharge, whichever came first, assessed up to 12 months | |
Secondary | Neurodevelopmental Impairment (NDI) | Moderate to severe neurodevelopmental impairment will be defined as Bayley III Cognitive <85, Bayley III Motor <85, gross motor functional classification system (GMFCS) 2 or greater, or bilateral "blind" despite corrective lenses or bilateral no functional hearing with or without amplification | From date of randomization until the date of first documented diagnosis or date of death from any cause or date of discharge, whichever came first, assessed up to 36 months | |
Secondary | Oxidative Stress | 8-Isoprostanes and 8-OHdG will be measured in serum and urine samples | from time of randomization to the first 24 hours after birth |
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