PDA Post NICU Discharge (PDA)
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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 :
Completed
First Posted : April 25, 2016
Last Update Posted : June 30, 2020
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Condition or disease |
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Patent Ductus Arteriosus |
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 |
Actual Primary Completion Date : | June 30, 2020 |
Actual Study Completion Date : | June 30, 2020 |

- 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 ]
- 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 |
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.

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
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 |
Responsible Party: | Pediatrix |
ClinicalTrials.gov Identifier: | NCT02750228 |
Other Study ID Numbers: |
PDX-002-15 |
First Posted: | April 25, 2016 Key Record Dates |
Last Update Posted: | June 30, 2020 |
Last Verified: | June 2020 |
Ductus Arteriosus, Patent Heart Defects, Congenital Cardiovascular Abnormalities |
Cardiovascular Diseases Heart Diseases Congenital Abnormalities |