Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome (SLIS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Florence.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Carlo Dani, University of Florence
ClinicalTrials.gov Identifier:
NCT01440868
First received: September 16, 2011
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Respiratory Distress Syndrome
Procedure: Sustained lung inflation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: SLI STUDY: Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome. A RCT Study

Resource links provided by NLM:


Further study details as provided by University of Florence:

Primary Outcome Measures:
  • Need of mechanical ventilation [ Time Frame: First 72 hrs of life ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Complication rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 13 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 276
Study Start Date: October 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SLI group
In this group the preterm infants will receive sustained lung inflation (SLI) with mask in the delivery room
Procedure: Sustained lung inflation
Sustained lung inflation (SLI) will be performed with mask using a pressure control system (Neopuff, Fisher & Paykel, Inc). Peak inflation pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a PEEP of 5 cm H2O. A second SLI manoeuvre will be repeated in case of persistent hearth failure (HR <100 bpm ).
Other Name: Lung recruitment
No Intervention: Control
Preterm infants will be assisted in the delivery room without sustained lung inflation.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 15 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • parental informed consent
  • gestational age 25-28 weeks

Exclusion Criteria:

  • fetal hydrops
  • major congenital malformation
  • inherited metabolic diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440868

Contacts
Contact: Carlo Dani, MD +39 055 7947428 cdani@unifi.it
Contact: Simone Pratesi, MD +39 055 7947792 simone.pratesi@unifi.it

Locations
Italy
Department of Surgical and Medical Critical Care, Unversity of Florence Not yet recruiting
Florence, Italy, 50134
Contact: Carlo Dani, MD    +39 055 7947428    cdani@unifi.it   
Contact: Simone Pratesi, MD    +39 055 7947792    simone.pratesi@unifi.it   
Principal Investigator: Carlo Dani, MD         
Sponsors and Collaborators
University of Florence
Investigators
Study Chair: Carlo Dani, MD University of Florence, Italy
  More Information

No publications provided by University of Florence

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlo Dani, Associate Professor of Pediatrics, University of Florence
ClinicalTrials.gov Identifier: NCT01440868     History of Changes
Other Study ID Numbers: 02-2011
Study First Received: September 16, 2011
Last Updated: September 26, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Florence:
Respiratory Distress Syndrome, Newborn
Delivery Rooms
Resuscitation
Premature Birth
Infant, Newborn
Respiration, Artificial

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 20, 2014