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Clinical Trials/EUCTR2018-000566-11-FI
EUCTR2018-000566-11-FI
Active, not recruiting
Phase 1

Extremely low gestational age infants' PARAcetamol Study - PARAS

niversity of Oulu0 sites40 target enrollmentApril 10, 2018
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ConditionsOpen ductus arteriosus of a premature infantTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
DrugsParacetamol Fresenius Kabi

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Open ductus arteriosus of a premature infant
Sponsor
niversity of Oulu
Enrollment
40
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 10, 2018
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Oulu

Eligibility Criteria

Inclusion Criteria

  • •All extremely premature (born before 28 gestation weeks) or low birth weight (\< 1000 g) infants treated in neonatal intensive care unit of Oulu University Hospital and who have an open ductus
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 40
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •\- Denial by the parents
  • •\- Severe congenital or chromosomal anomaly or severe clinical situation, that complicates the standard ductal therapies e.g. asphyxia, or persistent pulmonary hypertension of a newborn

Outcomes

Primary Outcomes

Not specified

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