Non-invasive Ventilation in Preterm Infants

Universitair Ziekenhuis Brussel

Status: Active, not recruiting

Conditions: Respiratory Distress Syndrome; Ventilator Lung; Newborn; Premature Birth

Treatments: Diagnostic Test: Lung and diaphragm ultrasound; Diagnostic Test: Titration procedure; Diagnostic Test: Electrical impedance tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT05987800

NIV study

Details and patient eligibility

About

This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional. For all participants prospective data collection will be conducted by chart review and by downloading ventilatory data from the ventilator. A registration of respiratory severity score will be done by a caregiver during the weaning period. This consists of a visual assessment of the work of breathing every 2 hours. For participants on NIV-NAVA consenting to the interventional part of the study a titration procedure will be conducted, afterwards serial electrical impedance tomography and lung and diaphragm ultrasound measurements will be done.

Enrollment: 120 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants (< 37 weeks GA) supported with non-invasive respiratory support for at least 24 hours. Non-invasive respiratory support can consist of non-invasive NAVA, nasal continuous positive airway pressure (nCPAP) or high flow nasal canula (flow > 2 liters/min).The support can be given as primary respiratory support or as respiratory support after weaning from invasive ventilation (= after extubation).
• Infants can only be enrolled after written and signed informed consent by the parents.

Exclusion criteria

• Infant born after a gestational age of 37 weeks or more.
• Infants with major congenital malformations or chromosomal abnormalities (eg trisomy 18, congenital diaphragmatic hernia…)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

Preterm infants on non-invasive respiratory support

Other group

Description:

All infants on non-invasive respiratory support will be studied. Only infants on less than 32 weeks of gestation at birth, will undergo an intervention.

Treatment:

Diagnostic Test: Electrical impedance tomography

Diagnostic Test: Titration procedure

Diagnostic Test: Lung and diaphragm ultrasound