Clinical trial NCT06408480: Neonatologist-performed Lung Ultrasound in the Delivery Room
Official title: Neonatologist-performed Lung Ultrasound During Immediate Transition After Birth to Predict the Need for Respiratory Support Persisting More Than 1 Hour - a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neonatal Disease
Keywords: neonatologist-performed lung ultrasound
postnatal transition
neonates
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 40
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of the change in lung ultrasound score according to Rodriguez-Fanjul et al. 2020
timeFrame: 60 minutes for all scans, 2-4 min per scan.
measure: The need for respiratory support persisting more than 1 hour after birth
timeFrame: 60 minutes
measure: Admission to the Neonatal Intensive Care Unit
timeFrame: 60 minutes
Secondary outcomes:
measure: Length of respiratory support
timeFrame: 60 minutes
measure: Mode of respiratory support
timeFrame: 60 minutes
measure: Routinely obtained capillary blood gas analysis of the newborn
timeFrame: 60 minutes
measure: Routinely obtained monitoring parameters- SpO2
timeFrame: 60 minutes
measure: Routinely obtained monitoring parameters- heart rate
timeFrame: 60 minutes
measure: Routinely obtained monitoring parameters- cerebral oxygen saturation
timeFrame: 60 minutes
measure: SpO2/FiO2
timeFrame: 60 minutes
measure: pH of the umbilical artery
timeFrame: 15 minutes
measure: APGAR score
timeFrame: 10 minutes
measure: Number of Participants with Presence of pregnancy risk factors
timeFrame: 10 minutes
measure: Number of Participants with Prenatal corticosteroids
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Division Neonatology, Dp. Pediatrics
state: Styria
Study officials:
affiliation: Division of Neonatology, Medical University of Graz, Austria
name: Bernhard Schwaberger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: