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

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Brief Title

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

Official Title

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

Brief Summary

      Patent ductus arteriosus (PDA), very common in preterm infants, is the delayed closure of a
      fetal blood vessel that limits blood flow through the lungs. PDA is associated with mortality
      and harmful long term outcomes including chronic lung disease and neurodevelopmental delay.
      Although, 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. Thus, PDA treatment is increasingly controversial and varies markedly
      between hospitals 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 1st month which infants are at
      highest risk for persistent PDA, and which combination of clinical risk factors,
      echocardiographic (echo) measurements, and serum biomarkers may best predict PDA-associated
      harm. The American Academy of Pediatrics has acknowledged early identification of infants at
      high-risk from PDA as a key research goal for informing future PDA-treatment effectiveness
      trials.

      Our objective is to use a prospective cohort of untreated infants with PDA to predict
      spontaneous ductal closure timing and identify echo measurements and biomarkers that are
      present in the 1st postnatal month and associated with long-term impairment. Our central
      hypothesis is that these risk factors can be determined to inform appropriate clinical
      treatments when necessary. Clinical, serum and urine biomarkers (BNP, NTpBNP, NGAL, H-FABP),
      and echo 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 echo methods, will facilitate the quantitative evaluation of myocardial
      performance. Aim 1 will estimate the probability of spontaneous PDA closure and predict the
      timing of ductal closure using echo, biomarker, and clinical predictors. Aim 2 will specify
      which echo predictors and biomarkers are associated with mortality and severity of
      respiratory illness at 36-weeks PMA. Aim 3 will identify which echo predictors and biomarkers
      are associated with 22- to 26-month neurodevelopment. All models will be validated in a
      separate cohort. This project will significantly contribute to clinical outcomes and PDA
      management 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 closure in those "high-risk"
      infants most likely to receive benefit.
    



Study Type

Observational [Patient Registry]


Primary Outcome

Patent ductus arteriosus (PDA) closure documented via echocardiogram by 36-weeks postmenstrual age (PMA) (binary)

Secondary Outcome

 Mortality by 36-weeks PMA (binary)

Condition

Patent Ductus Arteriosus


Study Arms / Comparison Groups

 Primary Study Cohort
Description:  450 Infants

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

675

Start Date

April 1, 2019

Completion Date

December 2024

Primary Completion Date

December 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Born between 23-weeks + 0 days (23_0/7 wks) and 29-weeks + 6 days (29_6/7 wks)
             gestation, inclusive

          -  Admitted to a study neonatal intensive care unit (NICU) within 72-hours of birth

          -  PDA noted on initial screening echo at <72 postnatal hours

        Exclusion Criteria:

          -  Life-threatening congenital abnormalities, including congenital heart disease (other
             than PDA or small atrial septal defects/patent foramen ovale/muscular VSD)

          -  Parents have chosen to allow natural death (placed a do not resuscitate order)
      

Gender

All

Ages

N/A - 72 Hours

Accepts Healthy Volunteers

No

Contacts

Jonathan L Slaughter, MD, MPH, 1-614-355-6643, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03782610

Organization ID

1800684

Secondary IDs

1R01HL145032

Responsible Party

Principal Investigator

Study Sponsor

Nationwide Children's Hospital

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Jonathan L Slaughter, MD, MPH, Principal Investigator, Nationwide Children's Hospital/The Ohio State University


Verification Date

July 2020