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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Ain Shams University
Sponsor:
Information provided by (Responsible Party):
Rania Ali El-Farrash, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01770925
First received: January 15, 2013
Last updated: January 16, 2013
Last verified: January 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: January 15, 2013
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2014