PDA Post NICU Discharge

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02750228

Acronym

PDA

Enrollment

208

Registered

2016-04-25

Start date

2016-05-31

Completion date

2020-06-30

Last updated

2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Weeks to 32 Weeks

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results