Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure

• Sponsor: Albany Medical College (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03026192
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Duration (Months): 18.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus	Device: near infrared spectroscopy

Study Design

• Study Type: Observational
• Actual Enrollment: 4 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Use of Near Infrared Spectroscopy in Preterm Infants to Determine Patent Ductus Arteriosus Closure Following Medical Treatment
• Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
no PDA These are infants who do not have a patent ductus arteriosus (PDA) as determine by echocardiography	Device: near infrared spectroscopy; Near infrared spectroscopy will be placed on infants both with and without hsPDA
hsPDA These are infants who have a hemodynamically significant PDA (hsPDA) as determined by echocardiography	Device: near infrared spectroscopy; Near infrared spectroscopy will be placed on infants both with and without hsPDA

Outcome Measures

Primary Outcome Measures

1. Change in NIRS readings [3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Minute to 1 Week
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• preterm infants less than 32 weeks gestation

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Albany Medical Center Neonatal Intesive Care Unit	Albany	New York	United States	12208

Sponsors and Collaborators

• Albany Medical College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kate Tauber, Assistant Professor, Albany Medical College
• ClinicalTrials.gov Identifier: NCT03026192
• Other Study ID Numbers: 4585
• First Posted: Jan 20, 2017
• Last Update Posted: Jan 23, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Ductus Arteriosus, Patent

Study Results

No Results Posted as of Jan 23, 2019