# Early Prediction of Spontaneous Patent Ductus Arteriosus (PDA) Closure and PDA-Associated Outcomes

> **NIH NIH R01** · RESEARCH INST NATIONWIDE CHILDREN'S HOSP · 2020 · $678,150

## Abstract

Project Summary/Abstract
Patent ductus arteriosus (PDA), very common in preterm infants, is associated with mortality and harmful long-
term outcomes including chronic lung disease and neurodevelopmental delay. Although, pharmacologic and/or
interventional treatments to close PDA likely benefit some infants, widespread routine treatment of all preterm
infants with PDA may not improve important outcomes. Left untreated, most PDAs close spontaneously by 44-
weeks postmenstrual age (PMA). Thus, PDA treatment is increasingly controversial and varies markedly 
between institutions and individual providers. The relevant and still unanswered clinical question is not whether to
treat all preterm infants with PDA, but whom to treat and when. Treatment detriments may outweigh benefits,
since all forms of deliberate PDA closure have potential adverse effects, especially in infants destined for early,
spontaneous PDA closure. Unfortunately, clinicians cannot currently predict in the first month which infants are
at highest risk for persistent PDA, and which combination of clinical risk factors, echo measurements, and 
serum biomarkers may best predict PDA-associated harm. The American Academy of Pediatrics in their PDA
Clinical Guidance Report acknowledged early identification of infants at high-risk from PDA as a key research
goal for informing future PDA-treatment effectiveness-trials. The objective in this application is to use a 
prospective cohort of untreated infants with PDA to predict spontaneous ductal closure timing and to identify 
clinical risk factors, echo measurements, and biomarkers that are present in the first postnatal month and 
associated with long-term impairment. Clinical, serum and urine biomarkers (BNP, NTpBNP, NGAL, H-FABP), and
echocardiographic variables sequentially collected during each of the first 4 postnatal weeks will be examined.
In addition myocardial deformation imaging (MDI) and tissue Doppler imaging (TDI), innovative 
echocardiographic methods, will facilitate the quantitative evaluation of myocardial performance. All Specific Aims will 
collect and examine data from preterm infants with PDA within the first postnatal month. Aim 1 will estimate the
probability of spontaneous PDA closure and predict the timing of ductal closure using echocardiographic, 
biomarker, and clinical predictors. Aim 2 will specify which echocardiographic predictors and biomarkers are 
associated with mortality and severity of respiratory illness at 36-weeks PMA. Aim 3 will identify which 
echocardiographic predictors and biomarkers are associated with 22- to 26-month neurodevelopment. All models will be
validated in a separate cohort of infants. This project will significantly contribute to clinical outcomes and 
management of PDA by reducing unnecessary and harmful overtreatment of infants with a high probability of early
spontaneous PDA closure, and will permit the development of outcomes-focused trials to examine the 
effectiveness of PDA c...

## Key facts

- **NIH application ID:** 9837478
- **Project number:** 5R01HL145032-02
- **Recipient organization:** RESEARCH INST NATIONWIDE CHILDREN'S HOSP
- **Principal Investigator:** Carl Backes
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $678,150
- **Award type:** 5
- **Project period:** 2018-12-15 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9837478

## Citation

> US National Institutes of Health, RePORTER application 9837478, Early Prediction of Spontaneous Patent Ductus Arteriosus (PDA) Closure and PDA-Associated Outcomes (5R01HL145032-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9837478. Licensed CC0.

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