Pre-TermNCT07216053
Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates
An observational study of Pre-Term and Respiratory Distress of Newborn, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
Respiratory morbidity presents a significant clinical challenge in the neonatal period, and an individual patient's clinical course is often difficult to predict. This is especially true for late-preterm infants, who share some of the same risks of premature babies in terms or respiratory morbidity, but whose births… Read more about this study
- Who is it for?
- Ages 34 to 36 weeks
- Conditions the study is for
- Pre-Term, Respiratory Distress of Newborn, Premature
- What is being tested?
- Point of care lung ultrasound
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2025to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 34 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Inborn infants born between 34w0d and 36w6d gestational age are admitted to the NICU or Well Baby Nursery.
Who may be able to join
- Inborn infants born between 34w0d and 36w6d gestational age
- In RA or 1 Litre per minute 1LPM NC (room air (RA) or nasal cannula (NC))
- Admitted to NICU or Well Baby Nursery (WBN)
Who cannot join
- Patients born <34 weeks or >36w6d
- Major genetic anomaly or syndromic condition
- Cardiac or pulmonary structural defects
- Cord pH <7.0 or 5 minute APGAR 5 or less
- Suspected fetal hemorrhage or other source of significant anemia at birth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hackensack Univeristy Medical Center
Hackensack, New Jersey, 07601
About this study
Respiratory morbidity presents a significant clinical challenge in the neonatal period, and an individual patient's clinical course is often difficult to predict. This is especially true for late-preterm infants, who share some of the same risks of premature babies in terms or respiratory morbidity, but whose births may not always be attended by a neonatologist, or who may be born at hospitals with lower level Neonatal Intensive Care Units (NICUs) and require transfer if they decompensate.
With this study, the aim is to 1) determine the efficacy of early point of care lung ultrasound (LUS) to predict respiratory decompensation in the first 48 hours of life in late preterm infants and 2) to compare the performance of three lung ultrasound scoring systems, 3 type-of-lung, high risk pattern and total LUS scoring systems.
Read the detailed description
Respiratory morbidity presents a significant clinical challenge in the neonatal period, and an individual patient's clinical course is often difficult to predict. This is especially true for late-preterm infants, who share some of the same risks of premature babies in terms or respiratory morbidity, but whose births may not always be attended by a neonatologist, or who may be born at hospitals with lower level Neonatal Intensive Care Units (NICUs) and require transfer if they decompensate.
Point of care (POC) lung ultrasound (LUS) is a relatively new and potentially underused method of assessing a neonate's respiratory status. The imaging modality has long been used to assess for common pulmonary pathologies such as pleural effusion and pneumothorax, but recent studies have begun to examine the utility of POC LUS for predicting a patient's clinical course, and potential need for escalation of respiratory support or NICU admission.
Existing studies regarding POC LUS as a predictor of need for respiratory support have focused primarily on either extremely or moderately premature or term infants, showing that three different scoring systems have been effective in predicting need for future respiratory support. Some studies have included late preterm infants, but this population reflected only a small portion of total study participants, and others did not include them at all. Given that late preterm neonates are a unique and at-risk population, the paucity of data in the existing knowledge presents a gap that should be addressed.
This study proposes conducting a prospective observational study that focuses on late preterm infants, which will assess whether the existing POC LUS scoring methodologies are useful in this population and will compare the efficacy of these scoring systems. It is proposed to recruit any infant born in the late preterm period who is initially on room air (RA) or nasal cannula (NC), conducting POC LUS and assigning scores per each of the three scoring systems, and assessing their respective predictive values for respiratory decompensation/escalation of support.
- Conditions
- Pre-Term, Respiratory Distress of Newborn, Premature
- Being tested
- Point of care lung ultrasound
- Keywords
- Lung Ultrasound, Respiratory Decompensation, Late Preterm Neonates, respiratory distress
- Medical subject headings
- Premature Birth, Pulmonary Atelectasis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care lung ultrasoundDiagnostic test
Point-of-care lung ultrasound (POC LUS) in their first 4 hours of life and be scored based on three established scoring systems
| Study group | Role | What they receive |
|---|---|---|
| Point of care lung ultrasound | Recruited babies will undergo point-of-care lung ultrasound (POC LUS) in their first 4 hours of life and be scored based on three established scoring systems. Infants will be followed during initial hospitalization. Respiratory decompensation will be determined by 48 hours of life. If respiratory decompensation occurs, the onset of signs of respiratory distress (determined by initiation of respiratory support) and the severity of respiratory distress (determined by length of time on respiratory support) will be measured. Receives: Diagnostic Test: Point of care lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of POC LUS scoring systems to predict respiratory decompensation in late preterm infants.
The binary outcome of escalation vs non-escalation of respiratory support will be used to predict the accuracy of the three established POC LUS scoring systems (Three type-of-lung, Full LUS, high-risk pattern assessment) for identifying late preterm infants who experience respiratory decompensation. Respiration decompensation is defined by need for respiratory support in the form of HFNC (high flow nasal cannula), CPAP (continuous positive airway pressure), NIMV (non-invasive mechanical ventilation), mechanical ventilation or surfactant administration in infants initially in room air (RA) or nasal cannula (NC). Sensitivity, specificity, and area under ROC curve can be used to calculate the predictive accuracy. Escalation of respiratory support determined in the first 48 hours of life.
Measured: Initial POC LUS will be performed within the first 4 hours of life. Escalation of respiratory support determined in the first 48 hours of life.
Compare the predictive accuracy of the three scoring systems
Comparison of the three POC LUS scoring systems performed in the first 4 hours of life to determine accuracy in predicting respiratory decompensation in the first 48 hours of life in late preterm infants. All three scores will be compared to the ultrasound results.
Measured: Initial POC LUS will be performed within the first 4 hours of life. Escalation of respiratory support determined in the first 48 hours of life.
Secondary outcomes (3)
Correlation between POC LUS and the timing of signs of respiratory distress
Determine if severity of POC LUS score correlates with onset of respiratory decompensation (i.e. does a worse LUS score correlate with earlier onset of respiratory decompensation).
Measured: Initial POCl LUS will be performed within the first 4 hours of life. Respiratory decompensation will be determined in the first 48 hours of life.
Correlation between POC LUS and the severity of respiratory distress as determined by the length of support needed.
Determine if severity of POC LUS score correlates with the length of time infant requires respiratory support in the form of HFNC, CPAP, NIMV or mechanical ventilation (i.e. does a worse LUS score correlate with earlier onset of respiratory decompensation).
Measured: Initial POCl LUS will be performed within the first 4 hours of life. Respiratory decompensation will be determined in the first 48 hours of life.
Correlation between POC LUS and the severity of respiratory distress as determined by the need for invasive respiratory support.
Determine if severity of POC LUS score correlates with the need for invasive versus non-invasive respiratory support.
Measured: Initial POCl LUS will be performed within the first 4 hours of life. Respiratory decompensation will be determined in the first 48 hours of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start6 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pre-TermStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Spillane, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216053
- Sponsor's protocol ID
- Pro2025-0102
- Status last verified
- May 2026
- First submitted
- 9 Oct 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raimondi F, Migliaro F, Sodano A, Ferrara T, Lama S, Vallone G, Capasso L. Use of neonatal chest ultrasound to predict noninvasive ventilation failure. Pediatrics. 2014 Oct;134(4):e1089-94. doi: 10.1542/peds.2013-3924. Epub 2014 Sep 1.
PubMed 25180278Poerio A, Galletti S, Baldazzi M, Martini S, Rollo A, Spinedi S, Raimondi F, Zompatori M, Corvaglia L, Aceti A. Lung ultrasound features predict admission to the neonatal intensive care unit in infants with transient neonatal tachypnoea or respiratory distress syndrome born by caesarean section. Eur J Pediatr. 2021 Mar;180(3):869-876. doi: 10.1007/s00431-020-03789-z. Epub 2020 Sep 19.
PubMed 32949291Xi G, Dai J, Wang X, Luo F, Lu C, Yang Y, Wang J. Ultrasound performed shortly after birth can predict the respiratory support needs of late preterm and term infants: A diagnostic accuracy study. Pediatr Pulmonol. 2021 Jul;56(7):2155-2163. doi: 10.1002/ppul.25389. Epub 2021 Apr 12.
PubMed 33768734Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.
PubMed 26237465Carnazzo SM, Nasikas S, Comisi FF. Lung Ultrasound in Neonates: A Narrative Review Along With Diagnostic Insights and Early Postnatal Applications. Cureus. 2024 Sep 30;16(9):e70487. doi: 10.7759/cureus.70487. eCollection 2024 Sep.
PubMed 39479113
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates
- ClinicalTrials.gov ID
- NCT07216053
- Acronym / sponsor ID
- Pro2025-0102
- Conditions
- Pre-Term, Respiratory Distress of Newborn, Premature
- Keywords
- Lung Ultrasound, Respiratory Decompensation, Late Preterm Neonates, respiratory distress
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 14 Oct 2025 (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.
Respiratory morbidity presents a significant clinical challenge in the neonatal period, and an individual patient's clinical course is often difficult to predict. This is especially true for late-preterm infants, who share some of the same risks of premature babies in terms or respiratory morbidity, but whose births may not always be attended by a neonatologist, or who may be born at hospitals with lower level Neonatal Intensive Care Units (NICUs) and require transfer if they decompensate.
With this study, the aim is to 1) determine the efficacy of early point of care lung ultrasound (LUS) to predict respiratory decompensation in the first 48 hours of life in late preterm infants and 2) to compare the performance of three lung ultrasound scoring systems, 3 type-of-lung, high risk pattern and total LUS scoring systems.
Detailed description
Respiratory morbidity presents a significant clinical challenge in the neonatal period, and an individual patient's clinical course is often difficult to predict. This is especially true for late-preterm infants, who share some of the same risks of premature babies in terms or respiratory morbidity, but whose births may not always be attended by a neonatologist, or who may be born at hospitals with lower level Neonatal Intensive Care Units (NICUs) and require transfer if they decompensate.
Point of care (POC) lung ultrasound (LUS) is a relatively new and potentially underused method of assessing a neonate's respiratory status. The imaging modality has long been used to assess for common pulmonary pathologies such as pleural effusion and pneumothorax, but recent studies have begun to examine the utility of POC LUS for predicting a patient's clinical course, and potential need for escalation of respiratory support or NICU admission.
Existing studies regarding POC LUS as a predictor of need for respiratory support have focused primarily on either extremely or moderately premature or term infants, showing that three different scoring systems have been effective in predicting need for future respiratory support. Some studies have included late preterm infants, but this population reflected only a small portion of total study participants, and others did not include them at all. Given that late preterm neonates are a unique and at-risk population, the paucity of data in the existing knowledge presents a gap that should be addressed.
This study proposes conducting a prospective observational study that focuses on late preterm infants, which will assess whether the existing POC LUS scoring methodologies are useful in this population and will compare the efficacy of these scoring systems. It is proposed to recruit any infant born in the late preterm period who is initially on room air (RA) or nasal cannula (NC), conducting POC LUS and assigning scores per each of the three scoring systems, and assessing their respective predictive values for respiratory decompensation/escalation of support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Point of care lung ultrasound | – | Diagnostic Test: Point of care lung ultrasoundRecruited babies will undergo point-of-care lung ultrasound (POC LUS) in their first 4 hours of life and be scored based on three established scoring systems. Infants will be followed during initial hospitalization. Respiratory decompensation will be determined by 48 hours of life. If respiratory decompensation occurs, the onset of signs of respiratory distress (determined by initiation of respiratory support) and the severity of respiratory distress (determined by length of time on respiratory support) will be measured. |
Who may qualify
- Ages
- 34 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Inborn infants born between 34w0d and 36w6d gestational age are admitted to the NICU or Well Baby Nursery.
Key inclusion criteria (3 listed)
- Inborn infants born between 34w0d and 36w6d gestational age
- In RA or 1 Litre per minute 1LPM NC (room air (RA) or nasal cannula (NC))
- Admitted to NICU or Well Baby Nursery (WBN)
Key exclusion criteria (5 listed)
- Patients born <34 weeks or >36w6d
- Major genetic anomaly or syndromic condition
- Cardiac or pulmonary structural defects
- Cord pH <7.0 or 5 minute APGAR 5 or less
- Suspected fetal hemorrhage or other source of significant anemia at birth
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 |
|---|---|---|
| Point of care lung ultrasoundPoint-of-care lung ultrasound (POC LUS) in their first 4 hours of life and be scored based on three established scoring systems | Diagnostic test | Point of care lung ultrasound |
Primary outcome
Accuracy of POC LUS scoring systems to predict respiratory decompensation in late preterm infants.
Time frame: Initial POC LUS will be performed within the first 4 hours of life. Escalation of respiratory support determined in the first 48 hours of life.
The binary outcome of escalation vs non-escalation of respiratory support will be used to predict the accuracy of the three established POC LUS scoring systems (Three type-of-lung, Full LUS, high-risk pattern assessment) for identifying late preterm infants who experience respiratory decompensation. Respiration decompensation is defined by need for respiratory support in the form of HFNC (high flow nasal cannula), CPAP (continuous positive airway pressure), NIMV (non-invasive mechanical ventilation), mechanical ventilation or surfactant administration in infants initially in room air (RA) or nasal cannula (NC). Sensitivity, specificity, and area under ROC curve can be used to calculate the predictive accuracy. Escalation of respiratory support determined in the first 48 hours of life.
Compare the predictive accuracy of the three scoring systems
Time frame: Initial POC LUS will be performed within the first 4 hours of life. Escalation of respiratory support determined in the first 48 hours of life.
Comparison of the three POC LUS scoring systems performed in the first 4 hours of life to determine accuracy in predicting respiratory decompensation in the first 48 hours of life in late preterm infants. All three scores will be compared to the ultrasound results.
3 secondary outcomes
Correlation between POC LUS and the timing of signs of respiratory distress
Time frame: Initial POCl LUS will be performed within the first 4 hours of life. Respiratory decompensation will be determined in the first 48 hours of life.
Correlation between POC LUS and the severity of respiratory distress as determined by the length of support needed.
Time frame: Initial POCl LUS will be performed within the first 4 hours of life. Respiratory decompensation will be determined in the first 48 hours of life.
Correlation between POC LUS and the severity of respiratory distress as determined by the need for invasive respiratory support.
Time frame: Initial POCl LUS will be performed within the first 4 hours of life. Respiratory decompensation will be determined in the first 48 hours of life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 25180278Raimondi F, Migliaro F, Sodano A, Ferrara T, Lama S, Vallone G, Capasso L. Use of neonatal chest ultrasound to predict noninvasive ventilation failure. Pediatrics. 2014 Oct;134(4):e1089-94. doi: 10.1542/peds.2013-3924. Epub 2014 Sep 1.
- Background: PubMed 32949291Poerio A, Galletti S, Baldazzi M, Martini S, Rollo A, Spinedi S, Raimondi F, Zompatori M, Corvaglia L, Aceti A. Lung ultrasound features predict admission to the neonatal intensive care unit in infants with transient neonatal tachypnoea or respiratory distress syndrome born by caesarean section. Eur J Pediatr. 2021 Mar;180(3):869-876. doi: 10.1007/s00431-020-03789-z. Epub 2020 Sep 19.
- Background: PubMed 33768734Xi G, Dai J, Wang X, Luo F, Lu C, Yang Y, Wang J. Ultrasound performed shortly after birth can predict the respiratory support needs of late preterm and term infants: A diagnostic accuracy study. Pediatr Pulmonol. 2021 Jul;56(7):2155-2163. doi: 10.1002/ppul.25389. Epub 2021 Apr 12.
- Background: PubMed 26237465Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.
- Background: PubMed 39479113Carnazzo SM, Nasikas S, Comisi FF. Lung Ultrasound in Neonates: A Narrative Review Along With Diagnostic Insights and Early Postnatal Applications. Cureus. 2024 Sep 30;16(9):e70487. doi: 10.7759/cureus.70487. eCollection 2024 Sep.
- Individual participant dataSharing planned: No
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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.
Nicole Spillane principal investigator
Hackensack Meridian Health
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 Pre-Term and Respiratory Distress of Newborn, run by Hackensack Meridian Health at 1 site in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanette Haugh (551-996- 3457, Jeanette.Haugh@HMHN.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of POC LUS scoring systems to predict respiratory decompensation in late preterm infants. (time frame: Initial POC LUS will be performed within the first 4 hours of life. Escalation of respiratory support determined in the first 48 hours of life.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07216053, which also lists 5 linked publications.
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 22 May 2026.