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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Pontificia Universidad Catolica de Chile.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sociedad Chilena de Pediatría
Information provided by:
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT00277030
First received: January 5, 2006
Last updated: August 22, 2006
Last verified: December 2005
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 5, 2006
Last Updated: August 22, 2006
Health Authority: Chile: Ministerio de Salud, Servicio de Salud Metropolitano Sur-Oriente

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

Additional relevant MeSH terms:
Birth Weight
Respiratory Distress Syndrome, Newborn
Syndrome
Body Weight
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Pulmonary Surfactants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014