- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07525167
Early Prediction of Bronchopulmonary Dysplasia in Preterm Infants Using Clinical Data
Early Prediction of Bronchopulmonary Dysplasia Using Clinical Data From the First Three Postnatal Weeks in Preterm Infants: A Retrospective Study With Large Language Models
Early Prediction of Bronchopulmonary Dysplasia in Preterm Infants Using Clinical Data from the First Three Postnatal Weeks with Large Language Models: A Retrospective Study This retrospective, observational study aims to evaluate the early prediction of bronchopulmonary dysplasia (BPD) in preterm infants using clinical data from the first, second, and third postnatal weeks. The study includes infants born before 32 weeks of gestation or weighing less than 1,500 grams, followed at the Neonatal Intensive Care Unit of Konya City Hospital.
The study will compare the performance of different large language models (LLMs), including ChatGPT, Gemini, and Claude, in predicting BPD development. Clinical variables such as gestational age, birth weight, respiratory support, oxygen requirement, mechanical ventilation duration, and infection status will be used.
Primary outcome: Accuracy of BPD risk prediction by each AI model compared to actual clinical outcomes. Secondary outcomes: Sensitivity and specificity of predictions, weekly prediction performance, and comparative performance among AI models.
The results will provide insight into the potential clinical utility of AI-based approaches for early BPD risk assessment in preterm infants.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Premature birth remains a major risk factor for neonatal morbidity and mortality, with bronchopulmonary dysplasia (BPD) representing one of the most significant chronic pulmonary complications in very preterm infants. Despite advances in neonatal intensive care, early and accurate prediction of BPD remains challenging due to the multifactorial nature of its pathophysiology, involving respiratory support requirements, oxygen exposure, infection burden, and perinatal factors.
This retrospective study evaluates the feasibility of using large language models (LLMs) for early prediction of BPD based on structured clinical data extracted from neonatal intensive care unit (NICU) records. Clinical variables are organized into weekly datasets corresponding to the first, second, and third postnatal weeks to capture the dynamic evolution of respiratory status and clinical condition over time.
Standardized and anonymized patient-level datasets are formatted into structured prompts and provided to multiple LLMs (ChatGPT, Gemini, and Claude). Each model receives identical input variables to ensure comparability. The models are instructed to generate categorical risk stratification (low, medium, high) along with corresponding probability estimates for BPD development.
To ensure methodological consistency, prompt engineering is standardized across all models and time points. Outputs are recorded for each weekly time window, allowing temporal comparison of predictive performance and assessment of how early postnatal data influences model accuracy.
Model outputs are subsequently compared with confirmed clinical outcomes of BPD development in the study population. Performance evaluation focuses on discriminative ability and calibration of predictions across different time points and models.
This design enables a systematic assessment of the potential role of LLM-based approaches in neonatal risk stratification and provides insight into their applicability as supportive clinical decision-making tools in neonatal intensive care settings.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Melek Büyükeren, Assoc. Prof. Dr.
- Phone Number: +90532-780-30-78
- Email: melekbuyukeren@gmail.com
Study Locations
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Konya, Turkey (Türkiye), 42020
- Konya City Hospital, İstiklal, Adana Çevre Yolu Cd. No:135/1
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Preterm infants born before 32 weeks of gestation or with birth weight <1,500 grams
- Admitted and followed in the Neonatal Intensive Care Unit (NICU) of Konya City Hospital
- Availability of complete clinical data in hospital records
- Documented bronchopulmonary dysplasia (BPD) outcome status
Exclusion Criteria:
- Presence of major congenital anomalies
- Incomplete or missing clinical data
- Death shortly after birth with insufficient follow-up data to determine BPD status
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Preterm Infants Cohort (<32 weeks or <1500 g)
This cohort includes preterm infants born before 32 weeks of gestation or weighing less than 1,500 grams, followed at the Neonatal Intensive Care Unit of Konya City Hospital.
Clinical data from the first, second, and third postnatal weeks are retrospectively collected for analysis.
No interventions are applied; AI models are used to predict BPD risk based on existing clinical data.
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Different large language models (ChatGPT, Gemini, Claude) will analyze retrospective clinical data to predict the risk of bronchopulmonary dysplasia (BPD).
This is an observational evaluation; no experimental treatment or therapy is administered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Accuracy of bronchopulmonary dysplasia (BPD) risk prediction by artificial intelligence (AI) models in preterm infants.
Time Frame: Postnatal weeks 1, 2, and 3
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The primary outcome is the accuracy of different large language models (ChatGPT, Gemini, Claude) in predicting BPD development.
AI-generated risk predictions will be compared to actual clinical outcomes to assess prediction correctness.
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Postnatal weeks 1, 2, and 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sensitivity and specificity of AI predictions
Time Frame: Postnatal weeks 1, 2, and 3
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Evaluate the true positive rate (sensitivity) and true negative rate (specificity) of each AI model's BPD risk predictions compared to actual outcomes.
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Postnatal weeks 1, 2, and 3
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Comparison of prediction accuracy across postnatal weeks
Time Frame: Postnatal weeks 1, 2, and 3
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Compare AI model performance at different postnatal weeks to determine if prediction accuracy improves as more clinical data becomes available.
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Postnatal weeks 1, 2, and 3
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Comparative performance of different AI models
Time Frame: Postnatal weeks 1, 2, and 3
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Compare AI model performance at different postnatal weeks to determine if prediction accuracy improves as more clinical data becomes available.
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Postnatal weeks 1, 2, and 3
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 1. Dai D, Chen H, Dong X, Chen J, Mei M, Lu Y, et al. Bronchopulmonary dysplasia predicted by developing a machine learning model of genetic and clinical information. Front Genet. 2021;12:689071. 2. Choi HJ, Lee G, Shin SH, Lee SM, Lee HC, Sohn JA, et al. Development and external validation of a machine learning model to predict bronchopulmonary dysplasia using dynamic factors. Sci Rep. 2025;15:13620. 3. Chen Y, Ma H, Liu X. Clinical and imaging data-based machine learning for early diagnosis of bronchopulmonary dysplasia: A meta-analysis. Curr Med Imaging. 2025;21:e15734056421036. 4. Özçelik G, Erol S, Korkut S, Köse Çetinkaya A, Özçelik H. Prediction of bronchopulmonary dysplasia using machine learning from chest X-rays of premature infants in the neonatal intensive care unit. Medicine (Baltimore).2025;104:e44322. 5. Akila K, Aravind Babu LR. Deep learning-driven early prediction of bronchopulmonary dysplasia using chest X-rays and clinical data. Electronics Communications and Computing Summit. 2025;3(3):90-97. 6. Zhang X, Wang Y, Li J, et al. Development and validation of machine learning models for predicting bronchopulmonary dysplasia risk in preterm neonates based on antenatal determinants. BMC Pediatr. 2025. 7. Li Y, Wang L, Chen Z, et al. Machine learning models combining oversampling techniques for prediction of bronchopulmonary dysplasia-associated pulmonary hypertension in very preterm infants. Respir Res. 2024;25:199.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Obstetric Labor, Premature
- Obstetric Labor Complications
- Pregnancy Complications
- Respiratory Tract Diseases
- Lung Diseases
- Infant, Premature, Diseases
- Infant, Newborn, Diseases
- Lung Injury
- Ventilator-Induced Lung Injury
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Premature Birth
- Bronchopulmonary Dysplasia
Other Study ID Numbers
- KSH_MB_2026_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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