NIV Strategies for RDS in Preterm Infants. NIV (Non Invasive Ventilation), RDS (Respiratory Distress Syndrome)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Noninvasive Ventilation Strategies for Early Treatment of RDS in Preterm Infants: An RCT

Conditions
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RDS of Prematurity

Intervention / Treatment
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* Device: NSIPPV
* Device: BiPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 2 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NSIPPV group<br>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. | Device: NSIPPV<br>* In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3.<br>|
| Active Comparator: BiPAP group<br>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. | Device: BiPAP<br>* In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of NIV Support | DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT | 10 days | 
| Failure of NIV Support | NUMBER OF NEWBORNS WHO FAILED WITH NON INVASIVE VENTILATION SUPPORT AND NEEDED INTUBATION AND INVASIVE MECHANICAL VENTILATION. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 2 month | 
| Bronchopulmonary Dysplasia (BPD) |  | 36 weeks of postconceptional age or time of discharge | 
| Pneumothorax (PNX) |  | 10 days | 
| Intraventricular Hemorrhage (IVH) |  | 1 month of life | 
| Periventricular Leukomalacia (PVL) |  | 3 month of life | 
| Retinopathy of Prematurity (ROP) |  | 3 month of life | 
| Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA) |  | first week of life | 
| Necrotizing Enterocolitis (NEC) |  | 1 month | 
| Newborns Who Received Multiple Surfactant Doses |  | 10 days | 
| Early Onset Sepsis |  | 5days from birth | 
| Late Onset Sepsis |  | after fifth days of life up 2 month of life | 
| Death |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIV, NSIPPV, BiPAP