NCT00277030

Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams

Comparative Trial of Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (planned)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: 5 Minutes – 1 Day
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Surfactant
DEVICE	Nasal CPAP

Timeline

• Start date: 2006-01-01
• First posted: 2006-01-13
• Last updated: 2006-08-24

Locations

3 sites across 1 country: Chile