Neonatologist-performed Lung Ultrasound in the Delivery Room

Neonatal Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06408480
• Other study ID #: 36-150 ex 23/24
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Medical University of Graz
• Contact: Bernhard Schwaberger, MD PhD
• Phone: +4331638530018
• Email: bernhard.schwaberger[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Neonatal Disease

Intervention

Diagnostic Test:
• Neonatologist-performed lung ultrasound
lung ultrasound conducted in min 5, 15, 30, 60 min after birth in late preterm and term infants

Locations

Country	Name	City	State
Austria	Division Neonatology, Dp. Pediatrics	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	The need for respiratory support persisting more than 1 hour after birth	binary - yes/ no	60 minutes
Primary	Admission to the Neonatal Intensive Care Unit	binary - yes/ no	60 minutes
Secondary	Length of respiratory support	in minutes	60 minutes
Secondary	Mode of respiratory support	non-invasive versus invasive ventilation	60 minutes
Secondary	Routinely obtained capillary blood gas analysis of the newborn	pCO2, pO2, pH, BE, HCO3, lactate, glucose	60 minutes
Secondary	Routinely obtained monitoring parameters- SpO2	arterial oxygen saturation (SpO2)	60 minutes
Secondary	Routinely obtained monitoring parameters- heart rate	heart rate in beats per minute (either by pulse oximetry or electrocardiography)	60 minutes
Secondary	Routinely obtained monitoring parameters- cerebral oxygen saturation	cerebral oxygen saturation (assessed by near-infrared spectroscopy)	60 minutes
Secondary	SpO2/FiO2	fraction of inspired oxygen ratio to O2 supply	60 minutes
Secondary	pH of the umbilical artery	in numbers	15 minutes
Secondary	APGAR score	Score ranges from 0 to 10, higher score indicates a better outcome	10 minutes
Secondary	Number of Participants with Presence of pregnancy risk factors	including intra-amniotic infection, and premature rupture of the membranes	10 minutes
Secondary	Number of Participants with Prenatal corticosteroids	binary - yes/ no	10 minutes