About this trial
The main hypothesis is that even preterm infants considered "stable" receiving non-invasive ventilation may be at risk of developing BPD due to an inhomogeneous distribution of ventilation. Identifying this characteristic from the first days of life by using EIT could, in the future, optimize non-invasive ventilation strategies as early as possible, such as lung recruitment manoeuvres, which are currently mainly used during invasive mechanical ventilation. In addition, comparing the LUS scores and homogeneity parameters derived from the EIT may help to further confirm the role of semi-quantitative lung ultrasound as a rapid, non-invasive, and readily available tool in NICUs for monitoring the lung function of preterm infants in the short and long term.
The primary objective is to measure homogeneity by Electrical Impedance Tomography (EIT) technology, used in the first weeks of life, for the development of BPD of grade 3, at 36 weeks postmenstrual age or death, in stable preterm infants requiring non-invasive ventilation. The secondary objective are to score if homogeneity at EIT are present and whether if they are associated with BPD. to ompare the distribution of regional lung ventilation obtained by EIT with the validated LUS scores.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
outborn infants
complex congenital malformations
metabolic, chromosomal, or other genetic abnormalities
pulmonary hypoplasia, congenital anomalies of surfactant proteins or other pulmonary abnormalities
Trial population
For this study we will enrol 104 preterm infants born between 26 and 32 weeks of gestational age and/or with a birth weight \< 1500g (very low birth weight infants - VLBW) with respiratory distress syndrome (RDS). The patients are considered eligible to be enrolled in the study if they are assisted in non-invasive ventilation (nasal continuous positive airway pressure -nCPAP- or high flow nasal -HFNC-) at 72h of life.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The prognostic value of homogeneity of ventilation assessed with EIT
The primary objective is to measure the benefit of an earlier detection of the risk to develop BPD at 36 weeks postmenstrual age in stable preterm infants requiring non-invasive, in the first weeks of life, scoring the homogeneity of ventilation using EIT technology ventilatio measured by EIT technology, used in the first weeks of life, for the development of BPD at 36 weeks postmenstrual age
Secondary outcomes
changes in homogeneity at EIT
to measure whether changes in homogeneity at EIT are present (YES/NO)
homogeneity at EIT are associated with BPD or death
Score changes in homogeneity at EIT and association to BPD or death
EIT and LUS score
measure the association of the distribution of regional lung ventilation obtained by EIT with the validated LUS scores
Sponsors and contacts
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