PDA Post NICU Discharge (PDA)

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

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 Overview

• Status: Completed
• Conditions: Patent Ductus Arteriosus

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Providence Alaska Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital & Medical Center
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center
  • Florida
    • Orlando, Florida, United States, 32806
      • Winnie Palmer Hospital for Women & Babies
    • Sunrise, Florida, United States, 33323
      • MEDNAX Center for Research, Education and Quality
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Northside Hospital
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Summerlin Hospital Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenvillle Memorial Hospital
  • Texas
    • Austin, Texas, United States, 78705
      • Seton Medical Center
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Medical Center
    • San Antonio, Texas, United States, 78229
      • Methodist Children's Hospital
    • San Antonio, Texas, United States, 78229
      • Children's Hospital of San Antonio
  • Washington
    • Tacoma, Washington, United States, 98405
      • Tacoma General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This is a prospective multicenter descriptive study to collect data on neonatal outcomes and treatment modalities of neonates diagnosed with a patent ductus arteriosus by echocardiogram and have an active diagnosis of a PDA at discharge from the hospital.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pediatrix

Publications and helpful links

General Publications

• Tolia VN, Powers GC, Kelleher AS, Walker MW, Herrman KK, Ahmad KA, Buchh B, Egalka MC, Hinkes M, Ma M, Richards M, Rudine AC, Sato RY, Shaffer KM, Clark RH. Low Rate of Spontaneous Closure in Premature Infants Discharged with a Patent Ductus Arteriosus: A Multicenter Prospective Study. J Pediatr. 2022 Jan;240:31-36.e2. doi: 10.1016/j.jpeds.2021.07.035. Epub 2021 Jul 20.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (ESTIMATE): April 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Ductus Arteriosus, Patent
• Other Study ID Numbers: PDX-002-15