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NCT Number: NCT06803355

Comparison of Congenital Pneumonia and Transient Tachypnea of the Newborn

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.

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Key information

Conditions

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

Age range

1 hour–24 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Behçet Uz Children's Hospital

Izmir, Konak, 35210, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Differentiation of TTN and congenital pneumonia using systemic immune-inflammation index (SII)

    Time frame: 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.

  2. Differentiation of TTN and congenital pneumonia using systemic inflammatory response index (SIRI)

    Time frame: 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 outcomes

  1. Effectiveness of Inflammatory Markers in Differentiating TTN and Congenital Pneumonia

    Time frame: 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) typically increase during inflammation, while lymphocyte- monocyte ratio (LMR) generally decreases.

  2. Differentiation of TTN and congenital pneumonia using C Reaktive Protein

    Time frame: 24 hours postnatally

    CRP has been shown to increase proportionally with the degree of inflammation.

Sponsors and collaborators

Lead sponsor

Dr. Behcet Uz Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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