Skip to main content
OpenTrials
Completed

NCT Number: NCT02750228

PDA Post NICU Discharge

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patent Ductus Arteriosus Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases

Age range

22 week–32 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Providence Alaska Medical Center, Anchorage, Alaska, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pediatrix

Other

Registry information

Official study title

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

Acronym: PDA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2016
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.