Non-invasive Ventilation as a Post Extubation Mode for RDS: a Randomized, Cotrolled Trial to Compare n-CPAP by n- Bipap and NIPPV
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Distress Syndrome
- Sponsor
- Ain Shams University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Failure of extubation during the first 48 hours post-extubation
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to compare between capap, n-bipap and NIPPV
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) and non invasive positive pressure ventilation(NIPPV) on the need for mechanical ventilation via endotracheal tube (MVET) to 7 days of age or less in preterm infants less than or equal to 34 weeks' gestation requiring intubation and surfactant if indicated for respiratory distress syndrome within 120 min of delivery . Second aim is to compare different outcomes of post-extubation n-CPAP , n-BiPAPand NIPPV.
Investigators
Rania Ali El-Farrash
principal investigator
Ain Shams University
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- total days of non invasive ventilation(for 10 days from the hour of extubation)
- length of hospital stay(30 days postnatal age)
- pneumothorax(10 days post extubation)