Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants

Patent Ductus Arteriosus Clinical Trial

Official title:

Changes of Cerebral Tissue Oxygen Saturation During Treatment of Patent Ductus Arteriosus in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428180
• Other study ID #: ULMNEONIRS03
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2011
• Last updated: April 5, 2016
• Start date: April 2011
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.

Description:

In this observational trial the investigators want to examine whether clinical or echocardiographic parameters of patent ductus arteriosus are related to

• cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD

• renal tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD

as measured by near infrared spectroscopy

and to

• stroke volume

• cardiac output

as measured by electrical cardiometry.

The investigators want to examine the impact of surgical and medical treatment for patent ductus on these parameters. The investigators want to compare the change of these parameters between responders to medical treatment and nonresponders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2016
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 34 Weeks

Eligibility

Inclusion Criteria:

• Newborn infant below 34 weeks postmenstrual age at the time of birth

• Patent ductus arteriosus with signs of hemodynamic relevance (as judged by the attending neonatologist)

• parental informed consent

Exclusion Criteria:

• Patent ductus arteriosus as part of malformation syndrome

• Additional major cardiovascular malformations

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus
• Prematurity of Fetus

Intervention

Drug:
• Indomethacin
3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)

Procedure:
• Surgical Ligation
In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.

Drug:
• Ibuprofen
3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg

Locations

Country	Name	City	State
Germany	University Medical Center	Ulm	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus		from 10 minutes before start of infusion until 4 hours after end of transfusion	No