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Clinical Trials/NCT02750228
NCT02750228CompletedNot Applicable

Patent Ductus Arteriosus Post NICU Discharge in Premature Infants: A Prospective Registry

Pediatrix16 sites in 1 country208 target enrollmentStarted: May 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Pediatrix
Enrollment
208
Locations
16
Primary Endpoint
Number of subjects that have a report of a spontaneous closure of PDA, medication intervention for closure of PDA or surgical intervention for closure of PDA
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to track post-discharge outcomes on prematurely born infants who are discharged from the NICU with a patent ductus arteriosus (PDA). Investigators plan to report on the spontaneous closure rate as well as the incidence of pulmonary and/or cardiac events in these infants. The goal is to identify risk factors associated with adverse outcomes in prematurely born infants who are sent home with a PDA.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
22 Weeks to 32 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Documentation of informed consent and authorization for participation.
  • •Estimated gestational age of 32 weeks or less.
  • •Active diagnosis of a PDA at discharge.
  • •At least one echocardiogram obtained during hospital stay documenting/ confirming PDA diagnosis.
  • •Parental agreement to provide follow-up information on their child.
  • •Cardiologist and/or Pediatrician willing to provide follow-up information on enrolled infants.

Exclusion Criteria

  • •No known major congenital anomalies (inborn error of metabolism, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, multiple congenital anomalies).
  • •Chromosomal / genetic disorders - Inherited metabolic disorders (Aa, fat or carbohydrate), Trisomies, Turner's syndrome,Vater's syndrome, CHARGE, DiGeorge or other 22q11 deletions, Major chromosomal duplications, deletions detectable on high resolution karyotype (not microarray).
  • •Parent(s) unwilling to participate in follow-up.

Outcomes

Primary Outcomes

Number of subjects that have a report of a spontaneous closure of PDA, medication intervention for closure of PDA or surgical intervention for closure of PDA

Time Frame: 18 months

Secondary Outcomes

  • Number of subjects with or without a closure of PDA that have heart failure, pulmonary arterial hypertension, a need for respiratory support and death(18 months)

Investigators

Sponsor
Pediatrix
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (16)

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