PDA Post NICU Discharge
PDA
Patent Ductus Arteriosus Post NICU Discharge in Premature Infants: A Prospective Registry
1 other identifier
observational
208
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2016
CompletedFirst Posted
Study publicly available on registry
April 25, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJune 30, 2020
June 1, 2020
4.2 years
March 23, 2016
June 29, 2020
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (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
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pediatrixlead
Study Sites (16)
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013, United States
Tucson Medical Center
Tucson, Arizona, 85712, United States
Winnie Palmer Hospital for Women & Babies
Orlando, Florida, 32806, United States
MEDNAX Center for Research, Education and Quality
Sunrise, Florida, 33323, United States
Northside Hospital
Atlanta, Georgia, 30328, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Greenvillle Memorial Hospital
Greenville, South Carolina, 29605, United States
Seton Medical Center
Austin, Texas, 78705, United States
Dell Children's Medical Center
Austin, Texas, 78723, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Children's Hospital of San Antonio
San Antonio, Texas, 78229, United States
Methodist Children's Hospital
San Antonio, Texas, 78229, United States
Tacoma General Hospital
Tacoma, Washington, 98405, United States
Related Publications (1)
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.
PMID: 34293369DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2016
First Posted
April 25, 2016
Study Start
May 1, 2016
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
June 30, 2020
Record last verified: 2020-06