Clinical Trial: Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: SLI STUDY: Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome. A RCT Study

Brief Summary:

BACKGROUND. Sustained lung inflation (SLI) associated to an adequate PEEP may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical ventilation (MV).

The investigators aim will be to demonstrate the hypothesis that the introduction of SLI in the delivery room protocol may reduce the need of MV in preterm infants.

STUDY DESIGN: Multicenter prospective randomized controlled trial. The study will be carried out at the neonatal care units of the Careggi Infants with a gestational age between 25 and 28 weeks will be eligible and randomized at birth to receive SLI or not. Peak inflation pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a positive end expiratory pressure (PEEP) of 5 cm H2O.

Primary endpoint will be the need of MV within the first 72 hrs of life (excluding the transient tracheal intubation for surfactant replacement: e.g. INSURE). Population size: hypothesizing that SLI maneuver might decrease the need of MV during the first 72 hours of life from 35 to 20% the investigators calculated that 138 newborns must be enrolled in each groups to detect this difference statistically significant with 80% power at 0.05 level.


Detailed Summary:

BACKGROUND Sustained lung inflation (SLI) applied at birth in the delivery room has been demonstrated to lead to clearance of lung fluid and achievement of a precocious functional residual capacity (FRC) both in animal and human studies. SLI associated to an adequate positive end expiratory pressure (PEEP) may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical ventilation (MV).

OBJECTIVES Our aim will be to demonstrate the hypothesis that the introduction of SLI in the delivery room protocol may reduce the need of MV in the first 72 hours of life in preterm infants at risk for RDS improving their respiratory outcome.

STUDY DESIGN This is a multicenter prospective randomized controlled trial. The study will be carried out at the neonatal care units of the Careggi University Hospital of Florence, the "V. Buzzi" Children Hospital of Milan, IRCCS Ospedale Maggiore Policlinico of Milan,the Catholic University of the Sacred Heart of Rome, the "S. Giovanni" Hospital of Rome, the Regional Hospital of Bozen, the Hospital of Varese, the the Sant'Anna University Hospital of Pisa, the "Maggiore" Hospital of Bologna, the "Di Venere" Hospital of Bari, the University Hospital of Foggia.

Inborn infants with a gestational age between 25 and 28 weeks will be eligible and randomized at birth in two groups. Group A: (SLI group) in this group the preterm infants will receive SLI with mask for initial alveolar recruitment using a pressure control system (Neopuff, Fisher & Paykel, Inc) in addition to American Academy of Pediatrics (AAP) guidelines for neonatal resuscitation. Peak inflation pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and the
Sponsor: University of Florence

Current Primary Outcome: Need of mechanical ventilation [ Time Frame: First 72 hrs of life ]

Preterm infants are at risk of developing respiratory distress syndrome requiring mechanical ventilation. Sustained lung inflation in the delivery room might contribute to decrease the need of mechanical ventilation during the first 72 hrs of life because later other factors (i.e.: sepsis)than prematurity itself could induce this need.


Original Primary Outcome: Same as current

Current Secondary Outcome: Complication rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 13 weeks ]

We will evaluate the occurrence of mechanical ventilation (MV) >3 hrs of life, length of MV and other non invasive respiratory supports, need of surfactant, mortality, the occurrence of the main prematurity complication such as bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH) , periventricular leukomalacia (PVL), retinopathy of prematurity (ROP) and necrotizing enterocolitis (NEC), sepsis, and length of neonata intensive care (NICU) and hospital stay.


Original Secondary Outcome: Same as current

Information By: University of Florence

Dates:
Date Received: September 16, 2011
Date Started: October 2011
Date Completion: September 2012
Last Updated: September 26, 2011
Last Verified: September 2011