NCT07525167

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2026

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 15, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

April 6, 2026

Last Update Submit

April 12, 2026

Conditions

Keywords

Bronchopulmonary DysplasiaMachine LearningArtificial Intelligencepreterm infant

Outcome Measures

Primary Outcomes (1)

  • Accuracy of bronchopulmonary dysplasia (BPD) risk prediction by artificial intelligence (AI) models in preterm infants.

    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.

    Postnatal weeks 1, 2, and 3

Secondary Outcomes (3)

  • Sensitivity and specificity of AI predictions

    Postnatal weeks 1, 2, and 3

  • Comparison of prediction accuracy across postnatal weeks

    Postnatal weeks 1, 2, and 3

  • Comparative performance of different AI models

    Postnatal weeks 1, 2, and 3

Study Arms (1)

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.

Other: Artificial Intelligence-Based Risk Prediction

Interventions

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.

Preterm Infants Cohort (<32 weeks or <1500 g)

Eligibility Criteria

Age0 Days - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A retrospective cohort of preterm infants (\<32 weeks gestation or \<1,500 g) admitted to the NICU of Konya City Hospital. Only infants with complete clinical data and documented BPD status are included. Both sexes are included.

You may qualify if:

  • 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

You may not qualify if:

  • Presence of major congenital anomalies
  • Incomplete or missing clinical data
  • Death shortly after birth with insufficient follow-up data to determine BPD status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital, İstiklal, Adana Çevre Yolu Cd. No:135/1

Konya, 42020, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary DysplasiaPremature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Melek Büyükeren, Assoc. Prof. Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Neonatology, Konya City Hospital

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 15, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

This study uses retrospective, de-identified clinical data from preterm infants admitted to the Neonatal Intensive Care Unit of Konya City Hospital. All patient information has been anonymized to protect privacy and confidentiality. Due to the sensitive nature of neonatal health data and institutional regulations, individual participant data (IPD) will not be shared with other researchers. The study results will be reported in aggregate form only, ensuring that no identifiable information is disclosed.

Locations