Lung Ultrasound Score, Neonatal Respiratory Distress
Conditions
Brief 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.
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
Interventions
DEVICEPoint 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.
DIAGNOSTIC_TESTSerum ANGPTL4
Samples will be withdrawn wthin the first 2 hours after birth, just after finishing the POC-LUS evaluation
Sponsors
Tanta University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Inclusion criteria
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
1. Preterm neonates with gestional age \<34 weeks. 2. Neonates with antenatal diagnosis of congenital anomalies of the lungs or thoracic cage. 3. Neonates with antenatal diagnosis of congenital heart disease. 4. Neonates with antenatal diagnosis of other major congenital anomalies or chromsomal abnormality. 5. Neonates born with severe perinatal asphyxia. 6. Neonates born with severe apnea requiring intubation in the delitery room.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NICU admission | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of respiratory support | From NICU admission till discontinuation of respiratory support up to 14 days | Time needed on respiratory support in days |
| Length of NICU stay | From NICU admission until discharge or death up to 21 days | Number of days from NICU admission until discharge or death |
Countries
Egypt
Outcome results
None listed