Early Prediction of Lung Injury in Preterm Infants Score

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age26-32
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
24 months

Secondary outcomes

1

changes in homogeneity at EIT

to measure whether changes in homogeneity at EIT are present (YES/NO)

Time frame
24 months
2

homogeneity at EIT are associated with BPD or death

Score changes in homogeneity at EIT and association to BPD or death

Time frame
24 months
3

EIT and LUS score

measure the association of the distribution of regional lung ventilation obtained by EIT with the validated LUS scores

Time frame
24 months

Other outcomes

Sponsors and contacts

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