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

Pontificia Universidad Catolica de Chile

Status and phase: Unknown; Phase 4

Conditions: Respiratory Distress Syndrome

Treatments: Device: Nasal CPAP; Drug: Surfactant

Study type: Interventional

Funder types: Other

Identifiers

NCT00277030

NEOUC022005

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 5 minutes to 1 day old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)