Comparison of Congenital Pneumonia and Transient Tachypnea of the Newborn

NCT06803355 | Completed

• 1 other identifier: BU-PEDS-CA-01
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Pneumonia; Transient Tachypnea of the Newborn

Keywords

Biomarker; Newborn; Inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Effectiveness of Inflammatory Markers in Differentiating TTN and Congenital Pneumonia

  within the first 24 hours postnatally

• Differentiation of TTN and congenital pneumonia using C Reaktive Protein

  24 hours postnatally

Study Arms (2)

congenital pneumonia

patients diagnosed with congenital pneumonia

Diagnostic Test: complete blood count, CRP, blood smear test, blood culture, chest X- ray

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

Interventions

complete blood count, CRP, blood smear test, blood culture, chest X- ray DIAGNOSTIC_TEST

Inflammation markers obtained from all cases will be evaluated and used to differentiate between transient tachypnea of the newborn and congenital pneumonia.

congenital pneumonia; transient tachypnea of the newborn

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (1)

Dr. Behçet Uz Children's Hospital

Izmir, Konak, 35210, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 38255338 BACKGROUND

• Kumar A, Bhat BV. Epidemiology of respiratory distress of newborns. Indian J Pediatr. 1996 Jan-Feb;63(1):93-8. doi: 10.1007/BF02823875.

  PMID: 10829971 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Complete blood count, blood smear test, C- reactive protein, blood culture

MeSH Terms

Conditions

Transient Tachypnea of the Newborn; Inflammation

Interventions

Blood Cell Count; Blood Culture; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Microbiological Techniques

Study Officials

• Şebnem Çalkavur, MD

  Dr. Behcet Uz Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Doctor

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: January 31, 2025
• Study Start: November 8, 2024
• Primary Completion: June 18, 2025
• Study Completion: July 25, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)