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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01428180

Enrollment

Registered

2011-09-02

Start date

2011-04-30

Completion date

2016-03-31

Last updated

2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus, Prematurity of Fetus

Keywords

preterm neonates, hemodynamically relevant patent ductus arteriosus

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.

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.

Interventions

DRUGIndomethacin

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

PROCEDURESurgical Ligation

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

DRUGIbuprofen

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 34 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026