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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00277030
First Posted: January 13, 2006
Last Update Posted: August 24, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sociedad Chilena de Pediatría
Information provided by:
Pontificia Universidad Catolica de Chile
  Purpose
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.

Condition Intervention Phase
Respiratory Distress Syndrome Drug: Surfactant Device: Nasal CPAP Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Trial of Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

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.

Estimated Enrollment: 110
Study Start Date: January 2006
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277030


Contacts
Contact: Soledad Urzúa, MD 56-2-3543348 soleurzua@gmail.com
Contact: Alvaro J Gonzalez, MD 56-2-3543349 alvgonza@med.puc.cl

Locations
Chile
Servicio de Neonatología, Hospital San José Recruiting
Santiago, Región Metropolitana, Chile
Contact: German Muhlhausen, MD    56-2-3832600 ext 2731    mygfam@mi.cl   
Sub-Investigator: German Muhlhausen, MD         
Servicio de Neonatología, Hospital Sótero del Rio Recruiting
Santiago, Región Metropolitana, Chile
Contact: Patricia Mena, MD    56-2-3536000 ext 6535    pmena@uec.uchile.cl   
Sub-Investigator: Patricia Mena, MD         
Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica Recruiting
Santiago, Región Metropolitana, Chile
Contact: Soledad Urzúa, MD    56-2-3543348    soleurzua@gmail.com   
Contact: Alvaro J Gonzalez, MD    56-2-3543349    alvgonza@med.puc.cl   
Principal Investigator: Soledad Urzúa, MD         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Sociedad Chilena de Pediatría
Investigators
Principal Investigator: Soledad Urzua, MD Pontificia Universidad Católica
Study Director: Alvaro Gonzalez, MD Pontificia Universidad Católica
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00277030     History of Changes
Other Study ID Numbers: NEOUC022005
First Submitted: January 5, 2006
First Posted: January 13, 2006
Last Update Posted: August 24, 2006
Last Verified: December 2005

Keywords provided by Pontificia Universidad Catolica de Chile:
Respiratory Distress Syndrome
Surfactant
Nasal CPAP

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Birth Weight
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Body Weight
Signs and Symptoms
Pulmonary Surfactants
Respiratory System Agents