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

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Status and phase: Completed; Phase 3; Phase 2

Conditions: RDS of Prematurity

Treatments: Device: BiPAP; Device: NSIPPV

Study type: Interventional

Funder types: Other

Identifiers

NCT02259400

NIV/RDS-01

Details and patient eligibility

About

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).

Full 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).

Enrollment: 280 patients

Sex: All

Ages: Under 2 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

NSIPPV group

Active Comparator group

Description:

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.

Treatment:

Device: NSIPPV

BiPAP group

Active Comparator group

Description:

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.

Treatment:

Device: BiPAP