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PDA Post NICU Discharge

Sponsor
Mednax Center for Research, Education, Quality and Safety (Other)
Overall Status
Completed
CT.gov ID
NCT02750228
Collaborator
(none)
208
Enrollment
16
Locations
50
Duration (Months)
13
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    208 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Patent Ductus Arteriosus Post NICU Discharge in Premature Infants: A Prospective Registry
    Study Start Date :
    May 1, 2016
    Actual Primary Completion Date :
    Jun 30, 2020
    Actual Study Completion Date :
    Jun 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Weeks to 32 Weeks
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence Alaska Medical Center Anchorage Alaska United States 99508
    2 St. Joseph's Hospital & Medical Center Phoenix Arizona United States 85013
    3 Tucson Medical Center Tucson Arizona United States 85712
    4 Winnie Palmer Hospital for Women & Babies Orlando Florida United States 32806
    5 MEDNAX Center for Research, Education and Quality Sunrise Florida United States 33323
    6 Northside Hospital Atlanta Georgia United States 30328
    7 Memorial Hospital of South Bend South Bend Indiana United States 46601
    8 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
    9 Greenvillle Memorial Hospital Greenville South Carolina United States 29605
    10 Seton Medical Center Austin Texas United States 78705
    11 Dell Children's Medical Center Austin Texas United States 78723
    12 Baylor University Medical Center Dallas Texas United States 75246
    13 Cook Children's Medical Center Fort Worth Texas United States 76104
    14 Children's Hospital of San Antonio San Antonio Texas United States 78229
    15 Methodist Children's Hospital San Antonio Texas United States 78229
    16 Tacoma General Hospital Tacoma Washington United States 98405

    Sponsors and Collaborators

    • Mednax Center for Research, Education, Quality and Safety

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mednax Center for Research, Education, Quality and Safety
    ClinicalTrials.gov Identifier:
    NCT02750228
    Other Study ID Numbers:
    • PDX-002-15
    First Posted:
    Apr 25, 2016
    Last Update Posted:
    Jun 30, 2020
    Last Verified:
    Jun 1, 2020
    Additional relevant MeSH terms:
    Ductus Arteriosus, Patent

    Study Results

    No Results Posted as of Jun 30, 2020