Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)

Summary

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.

Conditions

• Premature Infants
• Bronchopulmonary Dysplasia
• Intraventricular Hemorrhage
• Neurodevelopmental 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.

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• North Central Baptist Hospital

  collaborator UNKNOWN

• Sharp Mary Birch Hospital for Women & Newborns

  collaborator OTHER

• The Woman's Hospital of Texas

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• University of Florida Health

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Primary Children's Hospital

  collaborator OTHER

• Methodist Children's Hospital

  collaborator UNKNOWN

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Vishal Kapadia, MD · University of Texas Southwestern Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

0 Minutes

Max Age

10 Minutes

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-26

Primary Completion

2028-04-01

Completion

2029-04-01

Countries

• United States

Study Locations