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Use of Orotracheal Continuous Positive Airway Pressure (CPAP) in Newborns With Respiratory Failure

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 June 2011 by Hospital Angeles del Pedregal.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Hospital Angeles del Pedregal
ClinicalTrials.gov Identifier:
NCT01379820
First received: June 22, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose
Nasal CPAP is a excellent ventilation modality for newborns, but the incidence of pneumothorax is high (65.% - 9%) our hypothesis is when the baby open the mouth or crie the pressure in the airway is variable, the investigators evaluate a closed system with a intubated baby with a orotracheal system but with a elastic reservoir , the reservoir distend and the pressure in the airway is constant ,with this system the investigators protect the lungs for damage . The investigators want compare the use of nasal CPAP, mechanical ventilation and orotracheal CPAP with a compensation bag (gregory system) in newborns with respiratory failure .

Condition Intervention Phase
Neonatal Respiratory Failure
Device: OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Orotracheal CPAP ( Gregory System) for Treatment of Respiratory Failure in Newborns

Resource links provided by NLM:


Further study details as provided by Hospital Angeles del Pedregal:

Primary Outcome Measures:
  • mortality. pneumothorax , oxygen at 36 weeks of gestational age [ Time Frame: at 36 weeks of gestational age ] [ Designated as safety issue: Yes ]
    we compare mortality. pneumothorax , oxygen at 36 weeks of gestational age in all the groups , mechanical ventilation , Nasal CPAP and orotracheal CPAP


Secondary Outcome Measures:
  • infections rate, failure to treatment , other complications. [ Time Frame: 36 weeks of gestational age ] [ Designated as safety issue: Yes ]
    we compare infections rate, failure to treatment , other complications. in all the groups


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP)
    USE OF OROTRACHEAL CPAP FOR RESPIRATORY DISTRESS SYNDROME IN NEWBORNS .
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newborns with respiratory disease preterm less 32 week of gestational age.

Exclusion Criteria:

  • newborns without respiratory disease or 33 week of gestational age or more.
  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.

No Contacts or Locations Provided
  More Information

Responsible Party: Head , Neonatology Department, Hospital Angeles del Pedregal.
ClinicalTrials.gov Identifier: NCT01379820     History of Changes
Other Study ID Numbers: 01/2008 
Study First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Angeles del Pedregal:
NEONATAL RESPIRATORY FAILURE
OROTRACHEAL cpap
NASAL cpap
MECHANICAL VENTILATION
PNEUMOTHORAX
COMPENSATION BAG

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on December 09, 2016