Clinical trial NCT00277030: Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams
Official title: Comparative Trial of Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Respiratory Distress Syndrome
Keywords: Respiratory Distress Syndrome
Surfactant
Nasal CPAP
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Sociedad Chilena de Pediatría
First posted: 2006-01-13
Enrollment: 110
Sex: ALL
Minimum age (years): 5
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The need of intubation and surfactant administration.
Secondary outcomes:
measure: Mechanical ventilation and CPAP duration.
measure: Oxygen therapy.
measure: BPD incidence.
measure: Length of stay.
measure: Enteral feeding tolerance.
measure: Air leak.
measure: NEC, gastric perforation.
measure: Death.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Servicio de Neonatología, Hospital San José
state: Región Metropolitana
city: Santiago
country: Chile
facility: Servicio de Neonatología, Hospital Sótero del Rio
state: Región Metropolitana
city: Santiago
country: Chile
facility: Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica
state: Región Metropolitana
Study officials:
affiliation: Pontificia Universidad Católica
name: Soledad Urzua, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontificia Universidad Católica
name: Alvaro Gonzalez, MD
role: STUDY_DIRECTOR
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