PDA Post NICU Discharge

Pediatrix208 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

208

Conditions

Patent Ductus Arteriosus

Eligibility

Sex: ALLMin age: 22 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

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.

Locations (16)

Providence Alaska Medical Center

Anchorage, Alaska, United States

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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