Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)

NARecruitingINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

February 26, 2024

Primary Completion Date

April 1, 2028

Study Completion Date

April 1, 2029

Conditions
Premature InfantsBronchopulmonary DysplasiaIntraventricular HemorrhageNeurodevelopmental Outcomes
Interventions
OTHER

Sat75

As 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.

OTHER

Sat50

As 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.

Trial Locations (1)

75390

RECRUITING

University of Texas Southwestern Medical Center, Dallas

All Listed Sponsors
collaborator

University of Alabama at Birmingham

OTHER

collaborator

University of Oklahoma

OTHER

collaborator

North Central Baptist Hospital

UNKNOWN

collaborator

Sharp Mary Birch Hospital for Women & Newborns

OTHER

collaborator

The Woman's Hospital of Texas

OTHER

collaborator

Baylor College of Medicine

OTHER

collaborator

University of Florida Health

OTHER

collaborator

University of Pittsburgh Medical Center

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

University of Utah

OTHER

collaborator

Primary Children's Hospital

OTHER

collaborator

Methodist Children's Hospital

UNKNOWN

lead

University of Texas Southwestern Medical Center

OTHER