Comparison of Congenital Pneumonia and Transient Tachypnea of the Newborn

NCT ID: NCT06803355

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-08

Study Completion Date

2025-07-25

Brief Summary

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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

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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.

Conditions

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Congenital Pneumonia Transient Tachypnea of the Newborn

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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congenital pneumonia

patients diagnosed with congenital pneumonia

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Behcet Uz Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ceren Akdag

Assistant Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Şebnem Çalkavur, MD

Role: STUDY_DIRECTOR

Dr. Behcet Uz Children's Hospital

Locations

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Dr. Behçet Uz Children's Hospital

Izmir, Konak, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 38255338 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10829971 (View on PubMed)

Other Identifiers

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BU-PEDS-CA-01

Identifier Type: -

Identifier Source: org_study_id

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