Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-10
SponsorUniversity of Texas Southwestern Medical Center

About this 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.

Eligibility criteria

Qualifiers

None

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sat75
  • Sat50

Treatment groups

700 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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