Comparison of Congenital Pneumonia and Transient Tachypnea of the Newborn

Recruiting

• Conditions: Congenital Pneumonia; Transient Tachypnea of the Newborn

• Registration Number: NCT06803355
• Lead Sponsor: Dr. Behcet Uz Children's Hospital

Brief 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.

Study Timeline

• Study Start: 2024-11-08
• Status Verified: 2025-01
• Study First Submitted: 2025-01-26
• Study First Submitted QC: 2025-01-26
• Last Update Submitted: 2025-01-26
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Neonates born at ≥37 weeks of gestation, Admitted within the first 24 hours after birth with respiratory distress and a preliminary diagnosis of TTN

Exclusion Criteria

• Congenital anomalies Genetic syndromes Diagnosis of sepsis Patients without informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differentiation of TTN and congenital pneumonia using systemic immune-inflammation index (SII)	within the first 24 hours postnatally	The Systemic Immune-Inflammation Index (SII) is a biomarker derived from neutrophil count, lymphocyte count, and platelet count. It has been shown to increase proportionally with the degree of inflammation.
Differentiation of TTN and congenital pneumonia using systemic inflammatory response index (SIRI)	within the first 24 hours postnatally	The Systemic Inflammatory Response Index (SIRI) is a biomarker derived from neutrophil count, lymphocyte count, and monocyte count. It has been shown to increase proportionally with the degree of inflammation.

Secondary Outcome Measures

Name	Time	Method
Effectiveness of Inflammatory Markers in Differentiating TTN and Congenital Pneumonia	within the first 24 hours postnatally	inflammatory markers such as neutrophil-lymphocyte ratio (NLR), pan-immune-inflammation value (PIV) , platelet-lymphocyte ratio (PLR), AST to platelet ratio index (APRI) and C- reactive protein (CRP) typically increase during inflammation, while lymphocyte- monocyte ratio (LMR) generally decreases.

Trial Locations

Locations (1)

Dr. Behçet Uz Children's Hospital; 🇹🇷 İzmir, Konak, Turkey