Clinical Trials Directory

Trials / Completed

CompletedNCT06803355

Comparison of Congenital Pneumonia and Transient Tachypnea of the Newborn

The Value of Systemic Inflammation Markers in Differentiating Congenital Pneumonia From TTN in Neonates

Status
Completed
Phase
Study type
Observational
Enrollment
61 (actual)
Sponsor
Dr. Behcet Uz Children's Hospital · Academic / Other
Sex
All
Age
1 Hour – 24 Hours
Healthy volunteers
Not accepted

Summary

Accurate and timely differentiation between transient tachypnea of the newborn (TTN) and congenital pneumonia is essential in neonatal care, as it facilitates prompt initiation of appropriate treatment, reduces the risk of complications, and minimizes inappropriate antibiotic use. This study aims to assess the clinical utility of inflammatory markers, including the Systemic Immune-Inflammation Index (SII) and the Systemic Immune-Response Index (SIRI), in distinguishing TTN from congenital pneumonia in neonates. In scenarios where conventional diagnostic methods prove insufficient, these indices may offer clinicians a reliable and objective diagnostic approach, thereby optimizing antibiotic stewardship and reducing the duration of hospitalization.

Detailed description

Patients admitted to the Neonatal Intensive Care Unit of Dr. Behçet Uz Children's Hospital for respiratory distress will be analyzed. The following data will be recorded in the "case report form" for each patient: age, gender,Score for Neonatal Acute Physiology- Perinatal Extension-II (SNAPPE-II), birth weight (SGA/LGA), mode of delivery (elective/emergency C-section and vaginal delivery), gravidity, parity, maternal age, maternal comorbidities (GDM, preeclampsia/eclampsia, hypothyroidism, chorioamnionitis, urinary tract infection, asthma, obesity, epilepsy), presence of premature rupture of membranes or fever, sibling history, low APGAR score (\<7), leukocyte count, neutrophil count, lymphocyte count, platelet count, monocyte count, aspartate transferase (AST), C-reactive protein (CRP), blood smear test, blood culture, tracheal aspirate culture, antibiotics used and their duration, chest X-ray findings, length of hospital stay, onset and duration of oxygen therapy and method of administration, need for mechanical ventilation, and morbidity and mortality status.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTcomplete blood count, CRP, blood smear test, blood culture, chest X- rayInflammation markers obtained from all cases will be evaluated and used to differentiate between transient tachypnea of the newborn and congenital pneumonia.

Timeline

Start date
2024-11-08
Primary completion
2025-06-18
Completion
2025-07-25
First posted
2025-01-31
Last updated
2025-07-30

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06803355. Inclusion in this directory is not an endorsement.