Sustained Lung Inflation and Pulmonary Mechanics in Preterm Infant

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Withdrawn

Conditions: Respiratory Distress Syndrome; Lung Diseases; Preterm Birth

Treatments: Device: mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).; Other: Sustained lung inflation

Study type: Interventional

Funder types: Other

Identifiers

NCT02493920

MECCANICA SLI

Details and patient eligibility

About

Lung protection should start in the delivery room where, from the first breaths, the preterm infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the functional residual capacity (FRC). 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).

Further studies are required to evaluate the clinical utility of this maneuver. The ability to monitor what happens to the lungs while applying different recruitment maneuvers in preterm infants would allow the definition of a procedure that allows optimal assistance to improve the FRC. One promising approach is provided by the forced oscillation technique (FOT). During forced oscillations, a small amplitude sinusoidal pressure stimulus is applied to the airway opening and the mechanical response of the respiratory system is studied by means of the total respiratory input impedance (Zin). Zin is a complex number that can be expressed as real part, called resistance (Rrs), and imaginary part, called reactance (Xrs). Particularly, it has been recently shown that Xrs measured at 5 Hz is very sensible to changes in the mechanics of lung periphery and provides accurate information about lung volume recruitment and derecruitment. The main purpose of this work is to apply FOT to the assessment of lung function in newborns submitted to SLI at birth. The investigators hypothesized that the application in the delivery room of the SLI in the preterm infant is effective in achieving a greater FRC and therefore a greater value of Xrs compared to a control group not treated with the SLI.

Sex: All

Ages: 25 to 36 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age (GA) at least 25 weeks but less than 36 completed weeks by best obstetrical estimate

Exclusion criteria

• Refusal of antenatal informed consent
• Known major anomalies, pulmonary hypoplasia
• Severe perinatal suffering

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

SLI group

Experimental group

Description:

In this group the preterm infants will receive sustained lung inflation (SLI) with mask in the delivery room; the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique.

Treatment:

Other: Sustained lung inflation

Device: mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).

Control

No Intervention group

Description:

Preterm infants will be assisted in the delivery room with a continuous positive airway pressure (CPAP) of 5 cmH2O with mask and the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique.