Neonatologist-performed Lung Ultrasound in the Delivery Room

Recruiting

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
need of respiratory support > 60 min after birth	Neonatologist-performed lung ultrasound	Group comprises neonates in need of further respiratory support more than 60 minutes after birth.
need of respiratory support < 60 min after birth	Neonatologist-performed lung ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Determination of the change in lung ultrasound score according to Rodriguez-Fanjul et al. 2020	60 minutes for all scans, 2-4 min per scan.	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).
The need for respiratory support persisting more than 1 hour after birth	60 minutes	binary - yes/ no
Admission to the Neonatal Intensive Care Unit	60 minutes	binary - yes/ no

Secondary Outcome Measures

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

Locations (1): Division Neonatology, Dp. Pediatrics
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Graz, Styria, Austria