Status:
UNKNOWN
Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams
Lead Sponsor:
Pontificia Universidad Catolica de Chile
Collaborating Sponsors:
Sociedad Chilena de Pediatría
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
5-1 years
Phase:
PHASE4
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 ...
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,...
Eligibility Criteria
Inclusion
- 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
- Neonatal asphyxia, 5 minute Apgar \< 3 or cord pH \<7.0.
- Cardiac or respiratory malformation.
- Chromosomal disease.
- Significative pneumothorax.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00277030
Start Date
January 1 2006
Last Update
August 24 2006
Active Locations (3)
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1
Servicio de Neonatología, Hospital San José
Santiago, Santiago Metropolitan, Chile
2
Servicio de Neonatología, Hospital Sótero del Rio
Santiago, Santiago Metropolitan, Chile
3
Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica
Santiago, Santiago Metropolitan, Chile