Clinical Trial: Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With RDS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With Respiratory Distress Syndrome During Non Invasive Ventilation: a Randomized Controlled Trial

Brief Summary: The primary hypothesis of this study is reduction in need of mechanical ventilation in the first 72 hours of life (excluding the transient tracheal intubation performed for surfactant administration and the mechanical ventilation for lung recruitment) in spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 hours of life who received an HFOV recruitment maneuver (IN-REC-SUR-E) compared to no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation.

Detailed Summary:

EFFICACY OF A NEW TECHNIQUE -"IN-REC-SUR-E"- IN PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME DURING NON INVASIVE VENTILATION: A RANDOMIZED CONTROLLED TRIAL

BACKGROUND The initial stabilization on Continuous Positive Airway Pressure (CPAP) and provision of rescue surfactant only when necessary is at least as beneficial and quite possibly preferred over the standard therapy of intubation of all infants at risk in the delivery room and subsequent support with mechanical ventilation (2-4). The percentage of CPAP failure in the newborns of 25-28 weeks' gestation is 45 % (30/66) in the Australian experience (5), higher than that reported by Ammari et al. (25 %) (6) and similar to that reported by De Jaegere et al. (50 %) (7) and in the COIN trial (46 %) (2). As a potential alternative, the INSURE (INtubate, SURfactant, Extubate) approach (8) is very attractive. Recently, several studies have investigated the effectiveness of the association between non-invasive ventilation and surfactant, administered by transient intubation (INSURE), showing that it is effective in preventing the need for mechanical ventilation. Although beneficial in clinical practice, the INSURE method cannot be universally applied to all preterm neonates with Respiratory Distress Syndrome (RDS) and is unsuccessful in a particular section of this population. The INSURE failure rate recently reported in preterm infants of different gestational age widely ranges from 19 % to 69 % (10, 11). Unfortunately, no randomized controlled trials have directly evaluated the efficacy of INSURE in extremely preterm neonates (<28 weeks gestation) (8). Nevertheless, the data of the "Sustained Lung Inflation (SLI) study" (14) recently conducted on infants with GA 25+0- 28+6 weeks showed that nasal CPAP failure and need for Mechanical Ventilation (MV) at 72 hours of life was 53 % in the SLI group
Sponsor: Catholic University of the Sacred Heart

Current Primary Outcome: Need for mechanical ventilation within the first 3 days of life and therefore we consider IN-REC-SUR-E a success if mechanical ventilation is not required and a failure if the infant needs mechanical ventilation in the first 72 hours. [ Time Frame: First 72 hours of life ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of NCPAP [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  • Duration of conventional mechanical ventilation [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  • Duration of High-frequency oscillatory ventilation (HFOV) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  • Duration of O2-therapy [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  • Duration of hospitalization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  • Number of doses of surfactant [ Time Frame: First 72 hours of life ]
  • Occurrence of BPD (mild, moderate and severe forms) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  • Time to be out of any respiratory support [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Catholic University of the Sacred Heart

Dates:
Date Received: June 1, 2015
Date Started: November 2015
Date Completion: December 2017
Last Updated: April 7, 2017
Last Verified: April 2017