Neonatal Respiratory DistressNCT07809971

Predictive Value of Lung Ultrasound Combined With Serum ANGPL4 Levels for NICU Admission Needs in Late Preterm and Term Neonates With Respiratory Distress In The Transion Period

An observational study of Neonatal Respiratory Distress and Lung Ultrasound Score, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to evaluate the validity of point-of-care lung ultrasound (POC-LUS) and serum ANGPL4 levels for predicting NICU admission needs in late preterm and full-term neonates with respiratory distress shortly after birth in the transition period. Read more about this study

Who is it for?: Ages Up to 2 hours
Conditions the study is for: Neonatal Respiratory Distress, Lung Ultrasound Score
What is being tested?: Point of care lung ultrasound (POC-LUS) and Serum ANGPTL4
Type of treatment: Medical device
How many people: 80 participants
Where: 1 siteEgypt
Study dates: 1 Aug 2025to 31 Aug 2026
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 2 hours
All sexes
Child

Study population: 80 late preterm and term neonates with clinical evidence of respiratory distress soon after birth, at the NICU, Pediatrics Department, Tanta University Hospitals

This study will include 80 late preterm and term neonates (≥34 gestional weeks) who will show any clinical signs of respiratory distress in the delivery room or within 30 minutes after birth.

The exclusion criteria:

Preterm neonates with gestional age <34 weeks.
Neonates with antenatal diagnosis of congenital anomalies of the lungs or thoracic cage.
Neonates with antenatal diagnosis of congenital heart disease.
Neonates with antenatal diagnosis of other major congenital anomalies or chromsomal abnormality.
Neonates born with severe perinatal asphyxia.
Neonates born with severe apnea requiring intubation in the delitery room.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

faculty of medicine,Tanta University
Tanta, Q2x2+cp Tanta 2, Egypt, 31527

Other trials in Egypt

About this study

Read the detailed description

Given its concordance with conventional x-ray, lung ultrasound (LU) has become an attractive diagnostic tool in neonatal settings, with its validation against a wide range of imaging techniques and excellent inter-observer agreement. LU is currently used for diagnosing several neonatal respiratory morbidities and has been proposed for predicting further interventions, such as the need for surfactant treatment or mechanical ventilation in preterm infants. The routine adoption of point-of-care LU in the NICU is still experiencing some limitations. However, the implementation of routine LU in the NICU would further optimize the management of newborns with, or at risk of, respiratory morbidities. Lung ultrasound alone may not be sufficient to fully assess the severity and prognosis of neonatal respiratory distress, so it is particularly important to explore the combined use of other biomarkers. In this area, angiopoietin-like protein 4 (ANGPTL4) has gradually attracted attention. ANGPTL4, first discovered in 2000 as a member of the angiopoietin-like protein subfamily, whose expression can be prominently induced under ischemic and hypoxic conditions, participating in various physiological effects, including lipid metabolism, wound healing, and vascular injury.Therefore, serum ANGPTL4 may be an underlying biomarker for the diagnosis and prognosis of neonatal respiratory distress syndrome

Conditions: Neonatal Respiratory Distress, Lung Ultrasound Score
Being tested: Point of care lung ultrasound (POC-LUS), Serum ANGPTL4
Medical subject headings: Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Point of care lung ultrasound (POC-LUS)Device
It will be done whithin 2 hours after birth in the transition nursery area and will be recorded as per-validated LUS scoring system: each lung will be divided into 3 areas (upper anterior, lower anterior and lateral). For each lung area, a 0-3 point score will be given. The total score would be 0-18. A maximum score of 18 is the top denomination score for this study.
Serum ANGPTL4Diagnostic test
Samples will be withdrawn wthin the first 2 hours after birth, just after finishing the POC-LUS evaluation

Study groups in NCT07809971
Study group	Role	What they receive
NICU admitted		neonates admitted to the NICU Receives: Device: Point of care lung ultrasound (POC-LUS); Diagnostic Test: Serum ANGPTL4
Non- admitted		neonates not admitted to the NICU Receives: Device: Point of care lung ultrasound (POC-LUS); Diagnostic Test: Serum ANGPTL4

What is being measured

The primary outcome is the main question the study is designed to answer.

NICU admission
Need for NICU admission among late-preterm and term neonates presenting with respiratory distress during the early transitional period after birth. The decision for NICU admission will be made independently by the treating clinical team according to clinical criteria and standards of care, blinded to the research measurements of lung ultrasound score and serum ANGPTL4 level.
Measured: Within the first 2 hours after birth

Secondary outcomes (2)

Duration of respiratory support
Time needed on respiratory support in days
Measured: From NICU admission till discontinuation of respiratory support up to 14 days
Length of NICU stay
Number of days from NICU admission until discharge or death
Measured: From NICU admission until discharge or death up to 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202531 Aug 2026

First posted9 Sep 2026
Study start1 Aug 2025
Primary completion31 Aug 2026
Study completion31 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neonatal Respiratory DistressStudies of the same condition, open and under way.
More trials run by Tanta UniversityThe 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: Cohort
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07809971
Sponsor's protocol ID: LUS & ANGPL4 in NICU Admission
Status last verified: Sep 2026
First submitted: 1 Sep 2026
Last updated: 9 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Stark AR. Levels of neonatal care. Pediatrics. 2004;114(5):1341-1347. 2. Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, et al. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014;384(9938):189-205. 3. Martin RJ, Fanaroff AA, Walsh MC. Fanaroff and Martin's Neonatal-Perinatal Medicine. 11th ed. Philadelphia: Elsevier; 2019. 4. Hermansen CL, Lorah KN. Respiratory distress in the newborn. Am Fam Physician. 2007;76(7):987-94. 5. Dani C, Corsini I, Poggi C. Pneumothorax in the newborn: What to do? J Matern Fetal Neonatal Med. 2021;34(21):3548-3554. 6. Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, et al. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 update. Neonatology. 2019;115(4):432-450. 7. Liu J, Wang Y, Fu W, Yang Q, Zhang Q, Feng Z, et al. Diagnosis of neonatal respiratory distress using lung ultrasound. Medicine (Baltimore). 2014;93(27):e275. 8. Cloherty JP, Eichenwald EC, Hansen AR. Manual of Neonatal Care. 8th ed. Philadelphia: Wolters Kluwer; 2017. 9. Zanardo V, Simbi AK, Franzoi M, Soldà G, Salvadori A, Trevisanuto D. Neonatal respiratory morbidity risk and mode of delivery at term: Influence of timing of elective caesarean delivery. Acta Paediatr. 2004;93(5):643-647. 10. Stogianni A, Liosi M, Drossou V, Pliarchopoulou F, Nika H, Panagopoulos G. Neonatal outcomes in pregnancies complicated by diabetes. J Neonatal Perinatal Med. 2020;13(1):73-78. 11. Levine EM, Ghai V, Barton JJ, Strom CM. Mode of delivery and risk of respiratory diseases in newborns. Obstet Gynecol. 2001;97(3):439-442.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictive Value of Lung Ultrasound Combined With Serum ANGPL4 Levels for NICU Admission Needs in Late Preterm and Term Neonates With Respiratory Distress In The Transion Period
ClinicalTrials.gov ID: NCT07809971
Acronym / sponsor ID: LUS & ANGPL4 in NICU Admission
Conditions: Neonatal Respiratory Distress, Lung Ultrasound Score
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Tanta UniversityUniversity, hospital or other
Study start: 1 Aug 2025 (actual)
Primary completion: 31 Aug 2026 (actual)
Study completion: 31 Aug 2026 (actual)
First posted: 9 Sep 2026 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
NICU admitted	–	Device: Point of care lung ultrasound (POC-LUS), Diagnostic Test: Serum ANGPTL4neonates admitted to the NICU
Non- admitted	–	Device: Point of care lung ultrasound (POC-LUS), Diagnostic Test: Serum ANGPTL4neonates not admitted to the NICU

Who may qualify

Ages: Up to 2 hours
Sex: All
Age groups: Child
Study population: 80 late preterm and term neonates with clinical evidence of respiratory distress soon after birth, at the NICU, Pediatrics Department, Tanta University Hospitals

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 ultrasound (POC-LUS)It will be done whithin 2 hours after birth in the transition nursery area and will be recorded as per-validated LUS scoring system: each lung will be divided into 3 areas (upper anterior, lower anterior and lateral). For each lung area, a 0-3 point score will be given. The total score would be 0-18. A maximum score of 18 is the top denomination score for this study.	Device	NICU admitted, Non- admitted
Serum ANGPTL4Samples will be withdrawn wthin the first 2 hours after birth, just after finishing the POC-LUS evaluation	Diagnostic test	NICU admitted, Non- admitted

Primary outcome

NICU admission
Time frame: Within the first 2 hours after birth
Need for NICU admission among late-preterm and term neonates presenting with respiratory distress during the early transitional period after birth. The decision for NICU admission will be made independently by the treating clinical team according to clinical criteria and standards of care, blinded to the research measurements of lung ultrasound score and serum ANGPTL4 level.

2 secondary outcomes

Duration of respiratory support
Time frame: From NICU admission till discontinuation of respiratory support up to 14 days
Length of NICU stay
Time frame: From NICU admission until discharge or death up to 21 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
BackgroundStark AR. Levels of neonatal care. Pediatrics. 2004;114(5):1341-1347. 2. Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, et al. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014;384(9938):189-205. 3. Martin RJ, Fanaroff AA, Walsh MC. Fanaroff and Martin's Neonatal-Perinatal Medicine. 11th ed. Philadelphia: Elsevier; 2019. 4. Hermansen CL, Lorah KN. Respiratory distress in the newborn. Am Fam Physician. 2007;76(7):987-94. 5. Dani C, Corsini I, Poggi C. Pneumothorax in the newborn: What to do? J Matern Fetal Neonatal Med. 2021;34(21):3548-3554. 6. Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, et al. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 update. Neonatology. 2019;115(4):432-450. 7. Liu J, Wang Y, Fu W, Yang Q, Zhang Q, Feng Z, et al. Diagnosis of neonatal respiratory distress using lung ultrasound. Medicine (Baltimore). 2014;93(27):e275. 8. Cloherty JP, Eichenwald EC, Hansen AR. Manual of Neonatal Care. 8th ed. Philadelphia: Wolters Kluwer; 2017. 9. Zanardo V, Simbi AK, Franzoi M, Soldà G, Salvadori A, Trevisanuto D. Neonatal respiratory morbidity risk and mode of delivery at term: Influence of timing of elective caesarean delivery. Acta Paediatr. 2004;93(5):643-647. 10. Stogianni A, Liosi M, Drossou V, Pliarchopoulou F, Nika H, Panagopoulos G. Neonatal outcomes in pregnancies complicated by diabetes. J Neonatal Perinatal Med. 2020;13(1):73-78. 11. Levine EM, Ghai V, Barton JJ, Strom CM. Mode of delivery and risk of respiratory diseases in newborns. Obstet Gynecol. 2001;97(3):439-442.

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RecruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Respiratory Distress and Lung Ultrasound Score, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 9 Sep 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 Egypt. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NICU admission (time frame: Within the first 2 hours after birth). 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 NCT07809971, which also lists 1 linked publication.

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 9 Sep 2026.