Neonatal DiseaseNCT06408480
Neonatologist-performed Lung Ultrasound in the Delivery Room
An observational study of Neonatal Disease, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages Up to 60 minutes
- Conditions the study is for
- Neonatal Disease
- What is being tested?
- Neonatologist-performed lung ultrasound
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 minutes
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- Presence of cardiopulmonary malformations
- Patients with pneumothorax diagnosed by neonatologist-performed lung ultrasound
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Division Neonatology, Dp. Pediatrics
Graz, Styria, 8036
Melina Winkler, MD, +4331638530271, melina.winkler@medunigraz.at
Bernhard Schwabeger, MD, PhD, +4331638530018, bernhard.schwaberger@medunigraz.at
About this study
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
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.
Read the 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.
- Conditions
- Neonatal Disease
- Being tested
- Neonatologist-performed lung ultrasound
- Keywords
- neonatologist-performed lung ultrasound, postnatal transition, neonates
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatologist-performed lung ultrasoundDiagnostic test
lung ultrasound conducted in min 5, 15, 30, 60 min after birth in late preterm and term infants
| Study group | Role | What they receive |
|---|---|---|
| need of respiratory support > 60 min after birth | Group comprises neonates in need of further respiratory support more than 60 minutes after birth. Receives: 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. Receives: Diagnostic Test: Neonatologist-performed lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 60 minutes
Admission to the Neonatal Intensive Care Unit
binary - yes/ no
Measured: 60 minutes
Secondary outcomes (11)
Length of respiratory support
in minutes
Measured: 60 minutes
Mode of respiratory support
non-invasive versus invasive ventilation
Measured: 60 minutes
Routinely obtained capillary blood gas analysis of the newborn
pCO2, pO2, pH, BE, HCO3, lactate, glucose
Measured: 60 minutes
Routinely obtained monitoring parameters- SpO2
arterial oxygen saturation (SpO2)
Measured: 60 minutes
Routinely obtained monitoring parameters- heart rate
heart rate in beats per minute (either by pulse oximetry or electrocardiography)
Measured: 60 minutes
Routinely obtained monitoring parameters- cerebral oxygen saturation
cerebral oxygen saturation (assessed by near-infrared spectroscopy)
Measured: 60 minutes
SpO2/FiO2
fraction of inspired oxygen ratio to O2 supply
Measured: 60 minutes
pH of the umbilical artery
in numbers
Measured: 15 minutes
APGAR score
Score ranges from 0 to 10, higher score indicates a better outcome
Measured: 10 minutes
Number of Participants with Presence of pregnancy risk factors
including intra-amniotic infection, and premature rupture of the membranes
Measured: 10 minutes
Number of Participants with Prenatal corticosteroids
binary - yes/ no
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 May 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernhard Schwaberger, MD PhD, Principal investigator, Division of Neonatology, Medical University of Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408480
- Sponsor's protocol ID
- 36-150 ex 23/24
- Status last verified
- May 2024
- First submitted
- 25 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06408480
- Acronym / sponsor ID
- 36-150 ex 23/24
- Conditions
- Neonatal Disease
- Keywords
- neonatologist-performed lung ultrasound, postnatal transition, neonates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| need of respiratory support > 60 min after birth | – | Diagnostic Test: Neonatologist-performed lung ultrasoundGroup comprises neonates in need of further respiratory support more than 60 minutes after birth. |
| need of respiratory support < 60 min after birth | – | Diagnostic Test: Neonatologist-performed lung ultrasoundGroup 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. |
Who may qualify
- Ages
- Up to 60 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Presence of cardiopulmonary malformations
- Patients with pneumothorax diagnosed by neonatologist-performed lung ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neonatologist-performed lung ultrasoundlung ultrasound conducted in min 5, 15, 30, 60 min after birth in late preterm and term infants | Diagnostic test | need of respiratory support < 60 min after birth, need of respiratory support > 60 min after birth |
Primary outcome
Determination of the change in lung ultrasound score according to Rodriguez-Fanjul et al. 2020
Time frame: 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
Time frame: 60 minutes
binary - yes/ no
Admission to the Neonatal Intensive Care Unit
Time frame: 60 minutes
binary - yes/ no
11 secondary outcomes
Length of respiratory support
Time frame: 60 minutes
Mode of respiratory support
Time frame: 60 minutes
Routinely obtained capillary blood gas analysis of the newborn
Time frame: 60 minutes
Routinely obtained monitoring parameters- SpO2
Time frame: 60 minutes
Routinely obtained monitoring parameters- heart rate
Time frame: 60 minutes
Routinely obtained monitoring parameters- cerebral oxygen saturation
Time frame: 60 minutes
SpO2/FiO2
Time frame: 60 minutes
pH of the umbilical artery
Time frame: 15 minutes
APGAR score
Time frame: 10 minutes
Number of Participants with Presence of pregnancy risk factors
Time frame: 10 minutes
Number of Participants with Prenatal corticosteroids
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Schwaberger, MD PhD principal investigator
Division of Neonatology, Medical University of Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Disease, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernhard Schwaberger, MD PhD (+4331638530018, bernhard.schwaberger@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the change in lung ultrasound score according to Rodriguez-Fanjul et al. 2020 (time frame: 60 minutes for all scans, 2-4 min per scan.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.