Neonatologist-performed Lung Ultrasound in the Delivery Room

Neonatologist-performed Lung Ultrasound During Immediate Transition After Birth to Predict the Need for Respiratory Support Persisting More Than 1 Hour - a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Disease
• Intervention / Treatment: Diagnostic test: Neonatologist-performed lung ultrasound

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Bernhard Schwaberger, MD PhD; Phone Number: +4331638530018; Email: bernhard.schwaberger@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Division Neonatology, Dp. Pediatrics
      • Contact: Melina Winkler, MD; Phone Number: +4331638530271; Email: melina.winkler@medunigraz.at
      • Contact: Bernhard Schwabeger, MD, PhD; Phone Number: +4331638530018; Email: bernhard.schwaberger@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
need of respiratory support > 60 min after birth; Group comprises neonates in need of further respiratory support more than 60 minutes after birth.	Diagnostic test: Neonatologist-performed lung ultrasound; lung ultrasound conducted in min 5, 15, 30, 60 min after birth in late preterm and term infants
need of respiratory support < 60 min after birth; 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.	Diagnostic test: Neonatologist-performed lung ultrasound; lung ultrasound conducted in min 5, 15, 30, 60 min after birth in late preterm and term infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the change in lung ultrasound score according to Rodriguez-Fanjul et al. 2020	Score determined by neonatologist-performed lung ultrasound conducted at 5, 15, 30 and 60 minutes after birth. The lung ultrasound score will be calculated by performing bilateral longitudinal scans of the chest on the midclavicular, anterior, and posterior axillary line. For every scan a score is given ranging from 0 (for normal lung aeration) up to 3 (describing extended consolidations in the lung).	60 minutes for all scans, 2-4 min per scan.
The need for respiratory support persisting more than 1 hour after birth	binary - yes/ no	60 minutes
Admission to the Neonatal Intensive Care Unit	binary - yes/ no	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of respiratory support	in minutes	60 minutes
Mode of respiratory support	non-invasive versus invasive ventilation	60 minutes
Routinely obtained capillary blood gas analysis of the newborn	pCO2, pO2, pH, BE, HCO3, lactate, glucose	60 minutes
Routinely obtained monitoring parameters- SpO2	arterial oxygen saturation (SpO2)	60 minutes
Routinely obtained monitoring parameters- heart rate	heart rate in beats per minute (either by pulse oximetry or electrocardiography)	60 minutes
Routinely obtained monitoring parameters- cerebral oxygen saturation	cerebral oxygen saturation (assessed by near-infrared spectroscopy)	60 minutes
SpO2/FiO2	fraction of inspired oxygen ratio to O2 supply	60 minutes
pH of the umbilical artery	in numbers	15 minutes
APGAR score	Score ranges from 0 to 10, higher score indicates a better outcome	10 minutes
Number of Participants with Presence of pregnancy risk factors	including intra-amniotic infection, and premature rupture of the membranes	10 minutes
Number of Participants with Prenatal corticosteroids	binary - yes/ no	10 minutes

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Bernhard Schwaberger, MD PhD, Division of Neonatology, Medical University of Graz, Austria

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: neonates; neonatologist-performed lung ultrasound; postnatal transition
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases
• Other Study ID Numbers: 36-150 ex 23/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No