Evaluation of Nasal Non Invasive Ventilation Modalities in Management of Neonates With Respiratory Distress Using Lung Ultrasound
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Alexandria University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Duration of non-Invasive ventilation (NIV)
Study Overview
Brief Summary
This study aims to evaluate the effect of non-invasive ventilation (nIPPV)
, (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates <37 gestational week with moderate to severe RD using LUS as regard: I. Primary outcomes: Duration of non-Invasive ventilation. II. Secondary outcomes: Evaluation LUS over the 1 st 7 days of life or weaning from ventilation. Need for intubation and invasive ventilation. Duration of respiratory support. Need for surfactant. Oxygen saturation index and oxygen index. Broncho-pulmonary dysplasia; grade. Duration of hospital stay
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Hour to 24 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Preterm <37 wk. gestational age admitted to the NICU with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).
Exclusion Criteria
- •Obvious major congenital abnormalities.
- •Any of the baby intubated for resuscitation or for other reasons.
- •Neonates need invasive mechanical ventilation.
- •Pulmonary hemorrhage.
- •Severe cardiovascular instability.
- •Cardiopulmonary arrest needing prolonged resuscitation.
- •Birth asphyxia (one-minute Apgar score ≤ 3).
- •Major cardiac diseases (not including patent ductus arteriosus).
Outcomes
Primary Outcomes
Duration of non-Invasive ventilation (NIV)
Time Frame: First two weeks of life.
Describe the days of non-invasive ventilation , described in days number.
Secondary Outcomes
- Oxygen saturation index (OSI).(first one weeks of life.)
Investigators
Marwa Mohamed Farag
Assistant professor
Alexandria University