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

U

University of Ulm

Status

Completed

Conditions

Prematurity of Fetus
Patent Ductus Arteriosus

Treatments

Drug: Ibuprofen
Procedure: Surgical Ligation
Drug: Indomethacin

Study type

Observational

Funder types

Other

Identifiers

NCT01428180
ULMNEONIRS03

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

Under 34 weeks old

Volunteers

No 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

Trial design

35 participants in 3 patient groups

Indomethacin
Description:
Infants treated with Indomethacin
Treatment:
Drug: Indomethacin
Ibuprofen
Description:
Infants treated with Ibuprofen
Treatment:
Drug: Ibuprofen
Ligation
Description:
Infants undergoing surgical ligation
Treatment:
Procedure: Surgical Ligation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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