PDA Post NICU Discharge
Completed
Conditions studied: Patent Ductus Arteriosus
In brief
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.
Key facts
- Study ID
- NCT02750228
- Run by
- Pediatrix
- People needed
- 208
- Starts
- 2016-05-01
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2020-06-30
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Providence Alaska Medical Center — Anchorage, Alaska, United States
- St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
- Tucson Medical Center — Tucson, Arizona, United States
- Winnie Palmer Hospital for Women & Babies — Orlando, Florida, United States
- MEDNAX Center for Research, Education and Quality — Sunrise, Florida, United States
- Northside Hospital — Atlanta, Georgia, United States
- Memorial Hospital of South Bend — South Bend, Indiana, United States
- Summerlin Hospital Medical Center — Las Vegas, Nevada, United States
- Greenvillle Memorial Hospital — Greenville, South Carolina, United States
- Seton Medical Center — Austin, Texas, United States
- Dell Children's Medical Center — Austin, Texas, United States
- Baylor University Medical Center — Dallas, Texas, United States
- Cook Children's Medical Center — Fort Worth, Texas, United States
- Children's Hospital of San Antonio — San Antonio, Texas, United States
- Methodist Children's Hospital — San Antonio, Texas, United States
- Tacoma General Hospital — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.