NIV Strategies for RDS in Preterm Infants. NIV (Non Invasive Ventilation), RDS (Respiratory Distress Syndrome)
- Conditions
- RDS of Prematurity
- Interventions
- Device: NSIPPVDevice: BiPAP
- Registration Number
- NCT02259400
- Brief Summary
The purpose of this study is to determine whether two different strategies of Non Invasive Ventilation (NIV) have different effect on length and failure of NIV support in preterm infants with respiratory distress syndrome (RDS).
- Detailed Description
A Randomized Control Trial (RCT) conducted in two tertiary level Neonatal Intensive Care Unit (NICU). Ethical approval is needed. Informed and written consent will be obtained prior the delivery from the parents of the babies before the inclusion in the study. All inborn Very Low Birth Weight (VLBW) infants (Birthweight less than 1500 g and Gestational Age \< 32 weeks) with signs of RDS, spontaneously breathing and only supported by nasal-Continuous Positive Airway Pressure (NCPAP) in NICU, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies: Nasal Synchronized Intermittent Positive Pressure Ventilation (N-SIPPV) or Bilevel Continuous Positive Airway Pressure (BiPAP).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- All inborn VLBW infants (birthweight less than 1500 g and Gestational Age < 32 wks) with signs of RDS, spontaneously breathing and only supported by N-CPAP, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies.
- Apneic or severely depressed newborns requiring invasive ventilation, within two hours from birth
- Newborns with genetic disease and/or with major congenital malformations
- Newborns for whom it was not obtained informed consent within two hours from birth
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NSIPPV group NSIPPV The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter for LBW infants), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants'weight, will be used as interface. BiPAP group BiPAP The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants' weight.
- Primary Outcome Measures
Name Time Method Failure of NIV Support 10 days NUMBER OF NEWBORNS WHO FAILED WITH NON INVASIVE VENTILATION SUPPORT AND NEEDED INTUBATION AND INVASIVE MECHANICAL VENTILATION.
Duration of NIV Support 10 days DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT
- Secondary Outcome Measures
Name Time Method Retinopathy of Prematurity (ROP) 3 month of life Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA) first week of life Pneumothorax (PNX) 10 days Periventricular Leukomalacia (PVL) 3 month of life Newborns Who Received Multiple Surfactant Doses 10 days Death 1 month Intraventricular Hemorrhage (IVH) 1 month of life Late Onset Sepsis after fifth days of life up 2 month of life Bronchopulmonary Dysplasia (BPD) 36 weeks of postconceptional age or time of discharge Necrotizing Enterocolitis (NEC) 1 month Early Onset Sepsis 5days from birth