PDA Post NICU Discharge

Completed

• 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

Study Timeline

• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-25
• Study Start: 2016-05
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-29
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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.

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

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

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