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

Phase 4

• Conditions: Respiratory Distress Syndrome

• Registration Number: NCT00277030
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief 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.

Study Timeline

• Status Verified: 2005-12
• Study Start: 2006-01
• Study First Submitted: 2006-01-05
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-13
• Last Update Submitted: 2006-08-22
• Last Update Posted: 2006-08-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Birth Weight > 1500 g.
• First day of life.
• Clinical and radiological signs of RDS.
• Oxygen requirement over 30% to reach an oxygen saturation of 88%.
• Parent's consent approved.

Exclusion Criteria

• Neonatal asphyxia, 5 minute Apgar < 3 or cord pH <7.0.
• Cardiac or respiratory malformation.
• Chromosomal disease.
• Significative pneumothorax.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The need of intubation and surfactant administration.

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation and CPAP duration.
Oxygen therapy.
BPD incidence.
Length of stay.
Enteral feeding tolerance.
Air leak.
NEC, gastric perforation.
Death.

Trial Locations

Locations (3)

Servicio de Neonatología, Hospital Sótero del Rio; 🇨🇱 Santiago, Región Metropolitana, Chile

Servicio de Neonatología, Hospital San José; 🇨🇱 Santiago, Región Metropolitana, Chile

Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica; 🇨🇱 Santiago, Región Metropolitana, Chile