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PDA Post NICU Discharge

N/ACompletedNCT02750228
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

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

...and 6 more locations

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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