Congenital PneumoniaNCT06803355
Comparison of Congenital Pneumonia and Transient Tachypnea of the Newborn
An observational study of Congenital Pneumonia and Transient Tachypnea of the Newborn, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Congenital Pneumonia, Transient Tachypnea of the Newborn
- What is being tested?
- complete blood count, CRP, blood smear test, blood culture, chest X- ray
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Nov 2024to 25 Jul 2025
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 24 hours
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Neonates born at ≥37 weeks of gestation,
- Admitted within the first 24 hours after birth with respiratory distress
Who cannot join
- Congenital anomalies
- Genetic syndromes
- Diagnosis of sepsis
- Patients without informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Behçet Uz Children's Hospital
Izmir, Konak, 35210
About this study
Official title: The Value of Systemic Inflammation Markers in Differentiating Congenital Pneumonia From TTN in Neonates
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.
- Being tested
- complete blood count, CRP, blood smear test, blood culture, chest X- ray
- Keywords
- Biomarker, Newborn, Inflammation
- Medical subject headings
- Transient Tachypnea of the Newborn, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete blood count, CRP, blood smear test, blood culture, chest X- rayDiagnostic test
Inflammation markers obtained from all cases will be evaluated and used to differentiate between transient tachypnea of the newborn and congenital pneumonia.
| Study group | Role | What they receive |
|---|---|---|
| congenital pneumonia | patients diagnosed with congenital pneumonia Receives: 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 Receives: Diagnostic Test: complete blood count, CRP, blood smear test, blood culture, chest X- ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 24 hours postnatally
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.
Measured: within the first 24 hours postnatally
Secondary outcomes (2)
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.
Measured: within the first 24 hours postnatally
Differentiation of TTN and congenital pneumonia using C Reaktive Protein
CRP has been shown to increase proportionally with the degree of inflammation.
Measured: 24 hours postnatally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start8 Nov 2024
- Primary completion18 Jun 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Akdag, Dr. Behcet Uz Children's Hospital
- Investigators
- Şebnem Çalkavur, MD, Study director, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803355
- Sponsor's protocol ID
- BU-PEDS-CA-01
- Status last verified
- Jul 2025
- First submitted
- 26 Jan 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 38255338Kumar 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Systemic Inflammation Markers in Differentiating Congenital Pneumonia From TTN in Neonates
- ClinicalTrials.gov ID
- NCT06803355
- Acronym / sponsor ID
- BU-PEDS-CA-01
- Keywords
- Biomarker, Newborn, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| congenital pneumonia | – | Diagnostic Test: complete blood count, CRP, blood smear test, blood culture, chest X- raypatients diagnosed with congenital pneumonia |
| transient tachypnea of the newborn | – | Diagnostic Test: complete blood count, CRP, blood smear test, blood culture, chest X- raypatients diagnosed with transient tachypnea of the newborn |
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Neonates born at ≥37 weeks of gestation,
- Admitted within the first 24 hours after birth with respiratory distress
Key exclusion criteria (4 listed)
- Congenital anomalies
- Genetic syndromes
- Diagnosis of sepsis
- Patients without informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complete blood count, CRP, blood smear test, blood culture, chest X- rayInflammation markers obtained from all cases will be evaluated and used to differentiate between transient tachypnea of the newborn and congenital pneumonia. | Diagnostic test | congenital pneumonia, transient tachypnea of the newborn |
Primary outcome
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.
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.
2 secondary outcomes
Effectiveness of Inflammatory Markers in Differentiating TTN and Congenital Pneumonia
Time frame: within the first 24 hours postnatally
Differentiation of TTN and congenital pneumonia using C Reaktive Protein
Time frame: 24 hours postnatally
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 38255338Cao 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.
- Background: PubMed 10829971Kumar A, Bhat BV. Epidemiology of respiratory distress of newborns. Indian J Pediatr. 1996 Jan-Feb;63(1):93-8. doi: 10.1007/BF02823875.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şebnem Çalkavur, MD study director
Dr. Behcet Uz Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Pneumonia and Transient Tachypnea of the Newborn, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentiation of TTN and congenital pneumonia using systemic immune-inflammation index (SII) (time frame: within the first 24 hours postnatally). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06803355, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.