PDA Post NICU Discharge (PDA)

• ClinicalTrials.gov Identifier: NCT02750228
• Recruitment Status: Completed
• First Posted: April 25, 2016
• Last Update Posted: June 30, 2020
• Sponsor: Pediatrix
• Information provided by (Responsible Party): Pediatrix

Study Description

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.

Condition or disease
Patent Ductus Arteriosus

Study Design

• Study Type: Observational
• Actual Enrollment: 208 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Patent Ductus Arteriosus Post NICU Discharge in Premature Infants: A Prospective Registry
• Study Start Date: May 2016
• Actual Primary Completion Date: June 30, 2020
• Actual Study Completion Date: June 30, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 22 Weeks to 32 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Locations

United States, Alaska

Providence Alaska Medical Center

Anchorage, Alaska, United States, 99508

United States, Arizona

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States, 85013

Tucson Medical Center

Tucson, Arizona, United States, 85712

United States, Florida

Winnie Palmer Hospital for Women & Babies

Orlando, Florida, United States, 32806

MEDNAX Center for Research, Education and Quality

Sunrise, Florida, United States, 33323

United States, Georgia

Northside Hospital

Atlanta, Georgia, United States, 30328

United States, Indiana

Memorial Hospital of South Bend

South Bend, Indiana, United States, 46601

United States, Nevada

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States, 89144

United States, South Carolina

Greenvillle Memorial Hospital

Greenville, South Carolina, United States, 29605

United States, Texas

Seton Medical Center

Austin, Texas, United States, 78705

Dell Children's Medical Center

Austin, Texas, United States, 78723

Baylor University Medical Center

Dallas, Texas, United States, 75246

Cook Children's Medical Center

Fort Worth, Texas, United States, 76104

Children's Hospital of San Antonio

San Antonio, Texas, United States, 78229

Methodist Children's Hospital

San Antonio, Texas, United States, 78229

United States, Washington

Tacoma General Hospital

Tacoma, Washington, United States, 98405

Sponsors and Collaborators

Pediatrix

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pediatrix
• ClinicalTrials.gov Identifier: NCT02750228
• Other Study ID Numbers: PDX-002-15
• First Posted: April 25, 2016
• Last Update Posted: June 30, 2020
• Last Verified: June 2020

Additional relevant MeSH terms:

Ductus Arteriosus, Patent; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities