Trial | NCT00277030  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    surfactant ...

  • Study Participants

    110
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.
Study Started
Jan 31
2006
Last Update
Aug 24
2006
Estimate

Drug Surfactant

Device Nasal CPAP

Criteria 

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.
No Results Posted