Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure

Overview

Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in preterm infants after completing medical treatment for a hemodynamically significant PDA.

Full Title of Study: “Use of Near Infrared Spectroscopy in Preterm Infants to Determine Patent Ductus Arteriosus Closure Following Medical Treatment”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: June 30, 2018

Interventions

• Device: near infrared spectroscopy
  • Near infrared spectroscopy will be placed on infants both with and without hsPDA

Arms, Groups and Cohorts

• no PDA
  • These are infants who do not have a patent ductus arteriosus (PDA) as determine by echocardiography
• hsPDA
  • These are infants who have a hemodynamically significant PDA (hsPDA) as determined by echocardiography

Clinical Trial Outcome Measures

Primary Measures

• Change in NIRS readings
  • Time Frame: 3 days

Participating in This Clinical Trial

Inclusion Criteria

• preterm infants less than 32 weeks gestation Exclusion Criteria:

• infection, congenital heart disease, syndromic anomalies, and perinatal asphyxia.

Gender Eligibility: All

Minimum Age: 1 Minute

Maximum Age: 1 Week

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Albany Medical College
• Provider of Information About this Clinical Study
  • Principal Investigator: Kate Tauber, Assistant Professor – Albany Medical College