Clinical trial NCT02750228: PDA Post NICU Discharge
Official title: Patent Ductus Arteriosus Post NICU Discharge in Premature Infants: A Prospective Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Ductus Arteriosus
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 208
Sex: ALL
Minimum age (years): 22
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 18 months
Secondary outcomes:
measure: Number of subjects with or without a closure of PDA that have heart failure, pulmonary arterial hypertension, a need for respiratory support and death
timeFrame: 18 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Orlando
country: United States
facility: Winnie Palmer Hospital for Women & Babies
state: Florida
city: Sunrise
country: United States
facility: MEDNAX Center for Research, Education and Quality
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: Las Vegas
country: United States
facility: Summerlin Hospital Medical Center
state: Nevada
city: Greenville
country: United States
facility: Greenvillle Memorial Hospital
state: South Carolina
city: Austin
country: United States
facility: Seton Medical Center
state: Texas
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: San Antonio
country: United States
facility: Children's Hospital of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Methodist Children's Hospital
state: Texas
city: Tacoma
country: United States
facility: Tacoma General Hospital
state: Washington
Study officials:
References:
citation: 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.