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Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams

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ClinicalTrials.gov Identifier: NCT00277030
Recruitment Status : Unknown
Verified December 2005 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Recruiting
First Posted : January 13, 2006
Last Update Posted : August 24, 2006
Sponsor:
Collaborator:
Sociedad Chilena de Pediatría
Information provided by:
Pontificia Universidad Catolica de Chile

Tracking Information
First Submitted Date  ICMJE January 5, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date August 24, 2006
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
The need of intubation and surfactant administration.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00277030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2006)
  • Mechanical ventilation and CPAP duration.
  • Oxygen therapy.
  • BPD incidence.
  • Length of stay.
  • Enteral feeding tolerance.
  • Air leak.
  • NEC, gastric perforation.
  • Death.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
  • - Mechanical ventilation and CPAP duration.
  • - Oxygen therapy.
  • - BPD incidence.
  • - Length of stay.
  • - Enteral feeding tolerance.
  • - Air leak.
  • - NEC, gastric perforation.
  • - Death.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams
Official Title  ICMJE Comparative Trial of Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Distress Syndrome
Intervention  ICMJE
  • Drug: Surfactant
  • Device: Nasal CPAP
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: January 11, 2006)
110
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Day   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00277030
Other Study ID Numbers  ICMJE NEOUC022005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pontificia Universidad Catolica de Chile
Collaborators  ICMJE Sociedad Chilena de Pediatría
Investigators  ICMJE
Principal Investigator: Soledad Urzua, MD Pontificia Universidad Católica
Study Director: Alvaro Gonzalez, MD Pontificia Universidad Católica
PRS Account Pontificia Universidad Catolica de Chile
Verification Date December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP