Trials Sponsors Conditions Drugs Pricing

Conditions

Patent Ductus Arteriosus Prematurity of Fetus

Keywords

preterm neonateshemodynamically 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

IndomethacinDrug

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

Indomethacin

Surgical LigationProcedure

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

Ligation

Eligibility Criteria

AgeUp to 34 Weeks

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodProbability 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

Sponsors & Collaborators

University of Ulm
Otherlead

Study Sites (1)

University Medical Center

Ulm, Baden-Wurttemberg, 89075, Germany

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

IndomethacinIbuprofen

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

Manuel B Schmid, Dr. med.
University of Ulm
PRINCIPAL INVESTIGATOR

Enrollment

35 participants (actual enrollment reported by the registry).

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 2011

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Indomethacin

Ibuprofen

Ligation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Indomethacin

Ibuprofen

Ligation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations