Neonatologist-performed Lung Ultrasound in the Delivery Room

Medical University of Graz

Status: Enrolling

Conditions: Neonatal Disease

Treatments: Diagnostic Test: Neonatologist-performed lung ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT06408480

36-150 ex 23/24

Details and patient eligibility

About

The objective of this study is to evaluate the role of the neonatologist-performed lung ultrasound (NPLUS) during immediate transition after birth of late preterm and full-term neonates using the lung ultrasound score to predict the need of respiratory support persisting more than 1 hour after birth.

Full description

Lung ultrasound is an emerging clinical tool to assess the lung in a dynamic way. Recently, the focus has been on establishing lung ultrasound in the neonatal intensive care unit (NICU) as a point-of care application.

Neonates born by a Caesarean section are particularly prone to have an altered adaption to extrauterine life. Especially in the first hours after birth, respiratory distress syndromes (RDS) may occur due to delayed lung fluid clearance after birth.

While acute RDS in the first hours after birth may be a self-limiting disorder and therefore a benign condition, it remains difficult to identify neonates in need for further respiratory support at the NICU. Admission to the NICU not only causes parental stress but also contributes to additional healthcare costs.

There is emerging evidence that NPLUS is a reliable tool to differentiate between the causes leading to RDS in neonates. Using a neonatologist performed lung ultrasound score for the early identification of neonates in need of respiratory support persisting more than 1 hour would be therefore highly advantageous.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 60 minutes old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Late preterm neonates (born between 34 0/7 and 36 6/7 weeks of gestation) and full-term neonates (born later than 36 6/7 weeks of gestation) delivered by Caesarean section
• Presence of any sign of respiratory distress (defined as tachypnoea/ dyspnoea, grunting, flaring of the nostrils or chest retractions)
• Written informed consent obtained from the parents prior to birth.

Exclusion criteria

• Presence of cardiopulmonary malformations
• Patients with pneumothorax diagnosed by neonatologist-performed lung ultrasound

Trial design

40 participants in 2 patient groups

need of respiratory support > 60 min after birth

Description:

Group comprises neonates in need of further respiratory support more than 60 minutes after birth.

Treatment:

Diagnostic Test: Neonatologist-performed lung ultrasound

need of respiratory support < 60 min after birth

Description:

Group comprises neonates that show any signs of respiratory distress in the first 60 minutes, but do not need respiratory support more than 60 minutes after birth.

Treatment:

Diagnostic Test: Neonatologist-performed lung ultrasound