PDA Post NICU Discharge

Patent Ductus Arteriosus Clinical Trial

— PDA  

Official title:

Patent Ductus Arteriosus Post NICU Discharge in Premature Infants: A Prospective Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750228
• Other study ID #: PDX-002-15
• Status: Completed
• Start date: May 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2020
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Weeks to 32 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Locations

Country	Name	City	State
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	Northside Hospital	Atlanta	Georgia
United States	Dell Children's Medical Center	Austin	Texas
United States	Seton Medical Center	Austin	Texas
United States	Baylor University Medical Center	Dallas	Texas
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Greenvillle Memorial Hospital	Greenville	South Carolina
United States	Summerlin Hospital Medical Center	Las Vegas	Nevada
United States	Winnie Palmer Hospital for Women & Babies	Orlando	Florida
United States	St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	Children's Hospital of San Antonio	San Antonio	Texas
United States	Methodist Children's Hospital	San Antonio	Texas
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	MEDNAX Center for Research, Education and Quality	Sunrise	Florida
United States	Tacoma General Hospital	Tacoma	Washington
United States	Tucson Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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