Skip to content

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00277030
Enrollment
110
Registered
2006-01-13
Start date
2006-01-31
Completion date
Unknown
Last updated
2006-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Keywords

Respiratory Distress Syndrome, Surfactant, Nasal CPAP

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.

Interventions

DRUGSurfactant

Sponsors

Sociedad Chilena de Pediatría
CollaboratorUNKNOWN
Pontificia Universidad Catolica de Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Minutes to 1 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The need of intubation and surfactant administration.

Secondary

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

Countries

Chile

Contacts

Primary ContactSoledad Urzúa, MD
soleurzua@gmail.com56-2-3543348
Backup ContactAlvaro J Gonzalez, MD
alvgonza@med.puc.cl56-2-3543349

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026