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Completed

NCT Number: NCT07809971

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

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.

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Key information

Age range

Up to 2 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

faculty of medicine,Tanta University

Tanta, Q2x2+cp Tanta 2, Egypt, 31527, Egypt

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 ANGPTL4

Diagnostic Test

Samples will be withdrawn wthin the first 2 hours after birth, just after finishing the POC-LUS evaluation

Primary outcomes

  1. 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.

Secondary outcomes

  1. Duration of respiratory support

    Time frame: From NICU admission till discontinuation of respiratory support up to 14 days

    Time needed on respiratory support in days

  2. Length of NICU stay

    Time frame: From NICU admission until discharge or death up to 21 days

    Number of days from NICU admission until discharge or death

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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