Comparison of Congenital Pneumonia and Transient Tachypnea of the Newborn

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

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.

Study Overview

• Status: Completed
• Conditions: Transient Tachypnea of the Newborn; Congenital Pneumonia
• Intervention / Treatment: Diagnostic test: complete blood count, CRP, blood smear test, blood culture, chest X- ray

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 Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Turkey
  • Konak
    • İzmir, Konak, Turkey, 35210
      • Dr. Behcet Uz Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes term neonates (≥37 weeks of gestation) diagnosed with either transient tachypnea of the newborn (TTN) or congenital pneumonia. All patients are evaluated within the first 24 hours postnatally (0-24 hours). Only neonates admitted to the neonatal intensive care unit (NICU) for respiratory distress are included in the study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
congenital pneumonia; patients diagnosed with congenital pneumonia	Diagnostic test: complete blood count, CRP, blood smear test, blood culture, chest X- ray; Inflammation markers obtained from all cases will be evaluated and used to differentiate between transient tachypnea of the newborn and congenital pneumonia.
transient tachypnea of the newborn; patients diagnosed with transient tachypnea of the newborn	Diagnostic test: complete blood count, CRP, blood smear test, blood culture, chest X- ray; Inflammation markers obtained from all cases will be evaluated and used to differentiate between transient tachypnea of the newborn and congenital pneumonia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differentiation of TTN and congenital pneumonia using systemic immune-inflammation index (SII)	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.	within the first 24 hours postnatally
Differentiation of TTN and congenital pneumonia using systemic inflammatory response index (SIRI)	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.	within the first 24 hours postnatally

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of Inflammatory Markers in Differentiating TTN and Congenital Pneumonia	inflammatory markers such as neutrophil-lymphocyte ratio (NLR), pan-immune-inflammation value (PIV) , platelet-lymphocyte ratio (PLR), AST to platelet ratio index (APRI) typically increase during inflammation, while lymphocyte- monocyte ratio (LMR) generally decreases.	within the first 24 hours postnatally
Differentiation of TTN and congenital pneumonia using C Reaktive Protein	CRP has been shown to increase proportionally with the degree of inflammation.	24 hours postnatally

Collaborators and Investigators

• Sponsor: Dr. Behcet Uz Children's Hospital
• Investigators: Study Director: Şebnem Çalkavur, MD, Dr. Behcet Uz Children's Hospital

Publications and helpful links

General Publications

• Cao L, Liu X, Sun T, Zhang Y, Bao T, Cheng H, Tian Z. Predictive and Diagnostic Values of Systemic Inflammatory Indices in Bronchopulmonary Dysplasia. Children (Basel). 2023 Dec 25;11(1):24. doi: 10.3390/children11010024.
• Kumar A, Bhat BV. Epidemiology of respiratory distress of newborns. Indian J Pediatr. 1996 Jan-Feb;63(1):93-8. doi: 10.1007/BF02823875.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2024
• Primary Completion (Actual): June 18, 2025
• Study Completion (Actual): July 25, 2025

Study Registration Dates

• First Submitted: January 26, 2025
• First Submitted That Met QC Criteria: January 26, 2025
• First Posted (Actual): January 31, 2025

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Biomarker; Inflammation; Newborn
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Pneumonia; Tachypnea; Transient Tachypnea of the Newborn
• Other Study ID Numbers: BU-PEDS-CA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No