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PDA Post NICU Discharge (PDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02750228
Recruitment Status : Active, not recruiting
First Posted : April 25, 2016
Last Update Posted : April 5, 2019
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

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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 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 ]


Information from the National Library of Medicine

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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


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

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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 5, 2019
Last Verified: April 2019

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