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PDA Post NICU Discharge (PDA)

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ClinicalTrials.gov Identifier: NCT02750228
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

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
Patent Ductus Arteriosus

Study Type : Observational
Estimated Enrollment : 200 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 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine





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 [ Time Frame: 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 [ Time Frame: 18 months ]


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Ages Eligible for Study:   22 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750228


Contacts
Contact: Amy Kelleher, MSHS Amy_Kelleher@mednax.com

Locations
United States, Alaska
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Principal Investigator: Evelyn Rider, MD         
United States, Arizona
St. Joseph's Hospital & Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Principal Investigator: Kartik Mody, MD         
Tucson Medical Center Recruiting
Tucson, Arizona, United States, 85712
Principal Investigator: Moira Richards, MD         
United States, Florida
Winnie Palmer Hospital for Women & Babies Recruiting
Orlando, Florida, United States, 32806
Principal Investigator: Jose Perez, MD         
MEDNAX Center for Research, Education and Quality Recruiting
Sunrise, Florida, United States, 33323
Contact: Amy Kelleher, MSHS       amy_kelleher@mednax.com   
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30328
Principal Investigator: Michael Hinkes, MD         
United States, Indiana
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Principal Investigator: Robert White, MD         
United States, Nevada
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Principal Investigator: Meiyun Ma, MD         
United States, South Carolina
Greenvillle Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Principal Investigator: Whit Walker, MD         
United States, Texas
Seton Medical Center Recruiting
Austin, Texas, United States, 78705
Principal Investigator: Kristy Herrman, MD         
Dell Children's Medical Center Recruiting
Austin, Texas, United States, 78723
Principal Investigator: Kristy Herrman, MD         
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Principal Investigator: Mustafa Suterwala, MD         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: David Riley, MD         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: George Powers, MD         
Methodist Children's Hospital Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Matthew Egalka, MD         
United States, Washington
Tacoma General Hospital Recruiting
Tacoma, Washington, United States, 98405
Principal Investigator: Ray Sato, MD         
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety

Responsible Party: Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier: NCT02750228     History of Changes
Other Study ID Numbers: PDX-002-15
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities