Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

Launched by INDIANA UNIVERSITY · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment for respiratory distress syndrome (RDS) in premature infants, particularly in low- and middle-income African countries where more advanced medical equipment may not be available. The researchers want to see if giving a medication called surfactant using a less invasive method can help improve survival rates for these babies. They will also monitor any potential side effects from this treatment.

To participate in this trial, infants must be born between 24 and 35 weeks of gestation, weigh between 750 and 2000 grams, and show signs of respiratory distress. Eligible infants will receive surfactant therapy along with standard treatments and will be closely watched during their hospital stay to see how they respond. This study aims to find out if this new method of administering surfactant can help preterm infants breathe better and survive, making it an important step in improving care for vulnerable newborns.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks.
• • Silverman Anderson Score ≥5 before or after CPAP treatment.
• • Admitted to a study site within 24 hours of life.
• Exclusion Criteria:
• • Major congenital or genetic anomalies.
• • Active pulmonary hemorrhage.
• • Major craniofacial anomalies that preclude the successful use of CPAP