PDA Post NICU Discharge
- Conditions
- Patent Ductus Arteriosus
- Registration Number
- NCT02750228
- Lead Sponsor
- Pediatrix
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (16)
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
Greenvillle Memorial Hospital
🇺🇸Greenville, South Carolina, United States
Summerlin Hospital Medical Center
🇺🇸Las Vegas, Nevada, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Winnie Palmer Hospital for Women & Babies
🇺🇸Orlando, Florida, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
MEDNAX Center for Research, Education and Quality
🇺🇸Sunrise, Florida, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Dell Children's Medical Center
🇺🇸Austin, Texas, United States
Seton Medical Center
🇺🇸Austin, Texas, United States
Methodist Children's Hospital
🇺🇸San Antonio, Texas, United States
Children's Hospital of San Antonio
🇺🇸San Antonio, Texas, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States