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Search / Trial NCT05849077

Optimization of Saturation Targets and Resuscitation Trial (OptiSTART)

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · May 4, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Neonatal Resuscitation Oxygen

ClinConnect Summary

The OptiSTART trial is a study aimed at finding the best level of oxygen saturation (SpO2) for premature infants during their initial care after birth. Researchers want to determine whether aiming for a higher oxygen saturation level (75th percentile) compared to a lower level (50th percentile) can help these infants survive without developing serious health issues, such as lung disease or problems with brain development. The study will include about 700 infants born between 22 and 30 weeks of gestation who need resuscitation.

Eligible participants must be very premature babies and cannot have certain heart or lung conditions diagnosed before birth. Throughout the trial, all infants will receive standard care, with the only difference being the target levels of oxygen saturation they aim for. Parents can expect to have their infants monitored closely, and the study will track their health outcomes over time to see how the different oxygen levels affect their survival and long-term development. This research is important because it could help improve care for premature infants, ultimately leading to better health outcomes.

Gender

ALL

Eligibility criteria

  • 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

About University Of Texas Southwestern Medical Center

The University of Texas Southwestern Medical Center is a leading academic medical institution dedicated to advancing healthcare through innovative research, education, and clinical excellence. With a strong emphasis on translational medicine, the center conducts cutting-edge clinical trials aimed at developing novel therapies and improving patient outcomes across a wide range of diseases. Its multidisciplinary approach leverages a collaborative network of renowned faculty, state-of-the-art facilities, and a commitment to ethical research practices, positioning UT Southwestern at the forefront of medical discovery and patient care.

Locations

Dallas, Texas, United States

Patients applied

0 patients applied

Trial Officials

Vishal Kapadia, MD

Principal Investigator

University of Texas Southwestern Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported