Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams
Primary Purpose
Respiratory Distress Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Surfactant
Nasal CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring Respiratory Distress Syndrome, Surfactant, Nasal CPAP
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.
Sites / Locations
- Servicio de Neonatología, Hospital San JoséRecruiting
- Servicio de Neonatología, Hospital Sótero del RioRecruiting
- Unidad de Neonatología, Hospital Clínico Pontificia Universidad CatólicaRecruiting
Outcomes
Primary Outcome Measures
The need of intubation and surfactant administration.
Secondary Outcome Measures
Mechanical ventilation and CPAP duration.
Oxygen therapy.
BPD incidence.
Length of stay.
Enteral feeding tolerance.
Air leak.
NEC, gastric perforation.
Death.
Full Information
NCT ID
NCT00277030
First Posted
January 5, 2006
Last Updated
August 22, 2006
Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Sociedad Chilena de Pediatría
1. Study Identification
Unique Protocol Identification Number
NCT00277030
Brief Title
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
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Sociedad Chilena de Pediatría
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
Respiratory Distress Syndrome, Surfactant, Nasal CPAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Surfactant
Intervention Type
Device
Intervention Name(s)
Nasal CPAP
Primary Outcome Measure Information:
Title
The need of intubation and surfactant administration.
Secondary Outcome Measure Information:
Title
Mechanical ventilation and CPAP duration.
Title
Oxygen therapy.
Title
BPD incidence.
Title
Length of stay.
Title
Enteral feeding tolerance.
Title
Air leak.
Title
NEC, gastric perforation.
Title
Death.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Minutes
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soledad Urzúa, MD
Phone
56-2-3543348
Email
soleurzua@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alvaro J Gonzalez, MD
Phone
56-2-3543349
Email
alvgonza@med.puc.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soledad Urzua, MD
Organizational Affiliation
Pontificia Universidad Católica
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alvaro Gonzalez, MD
Organizational Affiliation
Pontificia Universidad Católica
Official's Role
Study Director
Facility Information:
Facility Name
Servicio de Neonatología, Hospital San José
City
Santiago
State/Province
Región Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
German Muhlhausen, MD
Phone
56-2-3832600
Ext
2731
Email
mygfam@mi.cl
First Name & Middle Initial & Last Name & Degree
German Muhlhausen, MD
Facility Name
Servicio de Neonatología, Hospital Sótero del Rio
City
Santiago
State/Province
Región Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Mena, MD
Phone
56-2-3536000
Ext
6535
Email
pmena@uec.uchile.cl
First Name & Middle Initial & Last Name & Degree
Patricia Mena, MD
Facility Name
Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica
City
Santiago
State/Province
Región Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soledad Urzúa, MD
Phone
56-2-3543348
Email
soleurzua@gmail.com
First Name & Middle Initial & Last Name & Degree
Alvaro J Gonzalez, MD
Phone
56-2-3543349
Email
alvgonza@med.puc.cl
First Name & Middle Initial & Last Name & Degree
Soledad Urzúa, MD
12. IPD Sharing Statement
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Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams
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