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

• Sponsor: University of Ulm (Other)
• Overall Status: Completed
• CT.gov ID: NCT01428180
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Duration (Months): 59
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prematurity of Fetus; Patent Ductus Arteriosus	Drug: Indomethacin; Procedure: Surgical Ligation; Drug: Ibuprofen

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 35 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Changes of Cerebral Tissue Oxygen Saturation During Treatment of Patent Ductus Arteriosus in Neonates
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Indomethacin Infants treated with Indomethacin	Drug: Indomethacin; 3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)
Ibuprofen Infants treated with Ibuprofen	Drug: Ibuprofen; 3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg
Ligation Infants undergoing surgical ligation	Procedure: Surgical Ligation; In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 34 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center	Ulm	Baden-Württemberg	Germany	89075

Sponsors and Collaborators

• University of Ulm

Investigators

• Principal Investigator: Manuel B Schmid, Dr. med., University of Ulm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manuel Schmid, Dr. med., University of Ulm
• ClinicalTrials.gov Identifier: NCT01428180
• Other Study ID Numbers: ULMNEONIRS03
• First Posted: Sep 2, 2011
• Last Update Posted: Apr 6, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Manuel Schmid, Dr. med., University of Ulm: preterm neonates; hemodynamically relevant patent ductus arteriosus
• Additional relevant MeSH terms: Ductus Arteriosus, Patent; Ibuprofen; Indomethacin

Study Results

No Results Posted as of Apr 6, 2016