Respiratory Distress Syndrome Clinical Trial
Official title:
Comparative Trial of Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams
The purpose of this study is to compare two different treatment strategies for RDS in preterm infants > 1500 grams and evaluate whether a selective surfactant administration would reduce the need of intubation, mechanical ventilation and surfactant use.
Respiratory Distress Syndrome (RDS) is a frequent respiratory problem of preterm infants and
an important cause of morbidity and mortality.
The management of this disease usually includes intubation, surfactant administration and
mechanical ventilation in infants less than 1500 grams. However, in patients over this
weight, the treatment has not been standardized and depends on the clinical progression of
oxygen requirements.
Hypothesis:
- Early CPAP and selective surfactant administration is an effective treatment for RDS in
infants >1500 g. This could decrease or avoid intubation and surfactant administration.
Comparison(s):
Early surfactant administration, when the FiO2 ≥ 0.4. compared to selective surfactant
administration when the arterial to alveolar oxygen tension ratio (a/APO2) is ≤ 0.21.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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