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Clinical Trials/EUCTR2017-005091-26-SE
EUCTR2017-005091-26-SE
Active, not recruiting
Phase 1

Clonidine for analgesia to preterm infants during neonatal intensive care – a prospective pharmacokinetic/pharmacodynamic/pharmacogenetic observational study. Cohort 2 in The SANNI project.

Skåne University Hospital0 sites100 target enrollmentDecember 22, 2017
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ConditionsSick preterm infants undergoing neonatal intensive care.Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Sick preterm infants undergoing neonatal intensive care.
Sponsor
Skåne University Hospital
Enrollment
100
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 22, 2017
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Skåne University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Preterm infants (\< gw 37\+0\) who are in need for analgesic or sedative medication according to clinical judgment (scoring with pain assessment scales; ALPS\-Neo and Comfort\-Neo)
  • •Existing arterial or venous cannulas/catheters for repeated non\-traumatic blood sampling
  • •Informed and written parental consent
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 100
  • •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

  • •Hemodynamic instability (same as in clinical routine).
  • •Cardiac malformations in need for postnatal surgery.
  • •Any serious medical condition or ethical issues that could, in the Investigators opinion, interfere with the study procedures.

Outcomes

Primary Outcomes

Not specified

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