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Nasal Continuous Positive Airway Pressure (n-CPAP) Versus Nasal Bilevel Positive Airway Pressure (n-BiPAP) for RDS

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 January 2013 by Rania Ali El-Farrash, Ain Shams University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01770925
First Posted: January 18, 2013
Last Update Posted: January 18, 2013
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.
Information provided by (Responsible Party):
Rania Ali El-Farrash, Ain Shams University
  Purpose
non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to compare between capap and n-bipap

Condition Intervention
Respiratory Distress Syndrome Device: N-CPAP Device: n-BiPAP Device: NIPPV

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Ventilation for RDS: a Randomized, Cotrolled Trial to Compare CPAP by Nasal Bipap

Resource links provided by NLM:


Further study details as provided by Rania Ali El-Farrash, Ain Shams University:

Primary Outcome Measures:
  • Failure of extubation during the first 48 hours post-extubation [ Time Frame: during the first 48 hours post-extubation ]

    This will be defined as:

    1. Uncompensated respiratory acidosis defined as pH less than 7.2 and partial pressure of carbon dioxide of more than 60 mmHg (or)
    2. Major apnea requiring mask ventilation


Secondary Outcome Measures:
  • Maintenance of successful extubation [ Time Frame: for 7 days from the hour of extubation ]

Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: n-CPAP
  • The n-CPAP group will receive at extubation a single level continuous positive airway pressure of 7 cm water for at least 48 hours before weaning is commenced. If the infant is stable for the preceding 48 hours defined by having fewer than three minor apneas and no increase in oxygen requirement, weaning will be permitted.
  • CPAP will be decreased from 6 cm water by 1 cm water every 24 hours if tolerated based on the above criteria. This will be done until a pressure of 4 cm water is reached.
  • If a pressure of 4 cm water is successfully tolerated for 48 hours then time off n-CPAP will be allowed. Thereafter, no fixed weaning regime based on number of hours in a day the infant will be allowed to come off CPAP will be prescribed.
Device: N-CPAP

The n-CPAP group will receive at extubation a single level continuous positive airway pressure of 7 cm water for at least 48 hours before weaning is commenced. If the infant is stable for the preceding 48 hours defined by having fewer than three minor apneas and no increase in oxygen requirement, weaning will be permitted.

CPAP will be decreased from 6 cm water by 1 cm water every 24 hours if tolerated based on the above criteria. This will be done until a pressure of 4 cm water is reached.

If a pressure of 4 cm water is successfully tolerated for 48 hours then time off n-CPAP will be allowed. Thereafter, no fixed weaning regime based on number of hours in a day the infant will be allowed to come off CPAP will be prescribed.

Active Comparator: n-BiPAP
  • The n-BiPAP group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water). Inspiratory time of one second and respiratory rate of 30/min will always be maintained.
  • The infant will then receive a mean airway pressure of 5 cm water (positive end expiratory pressure of 4 cm water and peak inspiratory pressure of 6 cm of water).
Device: n-BiPAP

The n-BiPAP group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water). Inspiratory time of one second and respiratory rate of 30/min will always be maintained.

The infant will then receive a mean airway pressure of 5 cm water (positive end expiratory pressure of 4 cm water and peak inspiratory pressure of 6 cm of water).

Active Comparator: NIPPV
o The NIPPV group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water).
Device: NIPPV
The NIPPV group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water).

Detailed Description:
The primary aim of this study is to compare the impact of early extubation to nasal continuous positive airway pressure (n-CPAP) versus nasal Bilevel positive airway pressure (n-BiPAP) on the need for mechanical ventilation via endotracheal tube (MVET) to 7 days of age or less in preterm infants <34 weeks' gestation requiring intubation and surfactant if indicated for respiratory distress syndrome within 60 min of delivery . Second aim is to compare different outcomes of post-extubation n-CPAP and n-BiPAP.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm infants lessthan 34wk

Exclusion Criteria:

  • preterms less than 1000 g birth weight
  • infants with apgar 0at 1 min
  • presenceofany other cause of respiratory distress as: congenital malformation affecting the cardiorespiratory system ,neuromuscular disease ,fetal hydrops , interventricular hemorrhage and chromosomal aberrations
  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): NCT01770925


Contacts
Contact: Rania A. El-Farrash, MD +201222208550 raniafarrash@hotmail.com
Contact: riham S. abd el-wahab, MBBCh

Sponsors and Collaborators
Ain Shams University
  More Information

Responsible Party: Rania Ali El-Farrash, principal investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT01770925     History of Changes
Other Study ID Numbers: Ain shams university
riham samy ( Registry Identifier: rania ali )
First Submitted: January 15, 2013
First Posted: January 18, 2013
Last Update Posted: January 18, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases