Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome (SLIS)
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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 |
- 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.
- 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 |
Inclusion Criteria:
- parental informed consent
- gestational age 25-28 weeks
Exclusion Criteria:
- fetal hydrops
- major congenital malformation
- inherited metabolic diseases
Contacts and Locations| Contact: Carlo Dani, MD | +39 055 7947428 | cdani@unifi.it |
| Contact: Simone Pratesi, MD | +39 055 7947792 | simone.pratesi@unifi.it |
| 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 | |
| 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 Respiratory Distress Syndrome, Adult Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 19, 2013