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CompletedNCT06803355Updated Jul 30, 2025

Comparison of Congenital Pneumonia and Transient Tachypnea of the Newborn

An observational study in Congenital Pneumonia and Transient Tachypnea of the Newborn, sponsored by Dr. Behcet Uz Children's Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 1 Hour to 24 Hours. Per ClinicalTrials.gov, last updated 2025-07-30.

Sponsored by Dr. Behcet Uz Children's Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
61
Ages
1 Hour to 24 Hours
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Congenital Pneumonia
  • Transient Tachypnea of the Newborn

Keywords

  • Biomarker
  • Newborn
  • Inflammation
03

In context

Transient Tachypnea of the Newborn

37 studies on the registry are indexed under Transient Tachypnea of the Newborn; 3 are open to participants now.

This study's enrollment of 61 is below the median of 105 across 10 observational studies indexed under Transient Tachypnea of the Newborn.

Browse Transient Tachypnea of the Newborn studies →

Lead sponsor

Dr. Behcet Uz Children's Hospital is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 24 Hours
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Congenital anomalies
  • Genetic syndromes
  • Diagnosis of sepsis
  • Patients without informed consent
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
61 participants (actual)
Target follow-up
15 Days
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within the first 24 hours postnatally

  2. 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.

    Time frame: within the first 24 hours postnatally

Secondary outcomes

  1. 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.

    Time frame: within the first 24 hours postnatally

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

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

    Time frame: 24 hours postnatally

07

Study locations

1 site
  • Dr. Behçet Uz Children's Hospital
    Izmir, Konak 35210, Turkey (Türkiye)
08

References and documents

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. PubMed 38255338 ↗
  • Kumar A, Bhat BV. Epidemiology of respiratory distress of newborns. Indian J Pediatr. 1996 Jan-Feb;63(1):93-8. doi: 10.1007/BF02823875. PubMed 10829971 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06803355
Lead sponsor
Dr. Behcet Uz Children's Hospital
Responsible party
Ceren Akdag (Assistant Doctor, Dr. Behcet Uz Children's Hospital) — Principal investigator
First posted
Jan 31, 2025
Start date
Nov 8, 2024
Primary completion
Jun 18, 2025
Completion
Jul 25, 2025
Last update
Jul 30, 2025

Study contacts

Şebnem Çalkavur, MD
study director · Dr. Behcet Uz Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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