Neonatologist-performed Lung Ultrasound in the Delivery Room

NCT06408480 | Recruiting DMC

• 1 other identifier: 36-150 ex 23/24
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Disease

Keywords

neonatologist-performed lung ultrasound; postnatal transition; neonates

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Length of respiratory support

  60 minutes

• Mode of respiratory support

  60 minutes

• Routinely obtained capillary blood gas analysis of the newborn

  60 minutes

• Routinely obtained monitoring parameters- SpO2

  60 minutes

• Routinely obtained monitoring parameters- heart rate

  60 minutes

Study Arms (2)

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

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

Interventions

Neonatologist-performed lung ultrasound DIAGNOSTIC_TEST

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; need of respiratory support > 60 min after birth

Eligibility Criteria

• Age: Up to 60 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Division Neonatology, Dp. Pediatrics

Graz, Styria, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bernhard Schwaberger, MD PhD

  Division of Neonatology, Medical University of Graz, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard Schwaberger, MD PhD

CONTACT

+4331638530018; bernhard.schwaberger@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 10, 2024
• Study Start: May 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

AU (1)