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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06803355
Enrollment
61
Registered
2025-01-31
Start date
2024-11-08
Completion date
2025-07-25
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Pneumonia, Transient Tachypnea of the Newborn

Keywords

Biomarker, Newborn, Inflammation

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.

Interventions

DIAGNOSTIC_TESTcomplete 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.

Sponsors

Dr. Behcet Uz Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 24 Hours
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differentiation of TTN and congenital pneumonia using systemic immune-inflammation index (SII)within the first 24 hours postnatallyThe 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 postnatallyThe 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

MeasureTime frameDescription
Effectiveness of Inflammatory Markers in Differentiating TTN and Congenital Pneumoniawithin the first 24 hours postnatallyinflammatory 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.
Differentiation of TTN and congenital pneumonia using C Reaktive Protein24 hours postnatallyCRP has been shown to increase proportionally with the degree of inflammation.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026