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

NCT01428180 | Completed

• 1 other identifier: ULMNEONIRS03
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity of Fetus; Patent Ductus Arteriosus

Keywords

preterm neonates; hemodynamically relevant patent ductus arteriosus

Outcome Measures

Primary Outcomes (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

Study Arms (3)

Indomethacin

Infants treated with Indomethacin

Drug: Indomethacin

Ibuprofen

Infants treated with Ibuprofen

Drug: Ibuprofen

Ligation

Infants undergoing surgical ligation

Procedure: Surgical Ligation

Interventions

Indomethacin DRUG

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

Indomethacin

Surgical Ligation PROCEDURE

In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.

Ligation

Ibuprofen DRUG

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

Ibuprofen

Eligibility Criteria

• Age: Up to 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm neonates with patent ductus arteriosus treated in our hospital

You may qualify if:

• 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

You may not qualify if:

• Patent ductus arteriosus as part of malformation syndrome
• Additional major cardiovascular malformations

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

University Medical Center

Ulm, Baden-Wurttemberg, 89075, Germany

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Indomethacin; Ibuprofen

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Manuel B Schmid, Dr. med.

  University of Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 2, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: March 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

DE (1)