Clinical trial NCT06803355: Comparison of Congenital Pneumonia and Transient Tachypnea of the Newborn
Official title: The Value of Systemic Inflammation Markers in Differentiating Congenital Pneumonia From TTN in Neonates
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Pneumonia
Transient Tachypnea of the Newborn
Keywords: Biomarker
Newborn
Inflammation
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Neonates born at ≥37 weeks of gestation, Admitted within the first 24 hours after birth with respiratory distress and a preliminary diagnosis of TTN

Exclusion Criteria:

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

Primary outcomes:
measure: Differentiation of TTN and congenital pneumonia using systemic immune-inflammation index (SII)
timeFrame: within the first 24 hours postnatally
measure: Differentiation of TTN and congenital pneumonia using systemic inflammatory response index (SIRI)
timeFrame: within the first 24 hours postnatally
Secondary outcomes:
measure: Effectiveness of Inflammatory Markers in Differentiating TTN and Congenital Pneumonia
timeFrame: within the first 24 hours postnatally
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dr. Behçet Uz Children's Hospital
state: Konak
Study officials:
affiliation: Dr. Behcet Uz Children's Hospital
name: Şebnem Çalkavur, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Kumar A, Bhat BV. Epidemiology of respiratory distress of newborns. Indian J Pediatr. 1996 Jan-Feb;63(1):93-8. doi: 10.1007/BF02823875.