Study of clonidine in preterm infants undergoing neonatal intensive care. Cohort 2 in the SANNI Project.

Phase 1

• Conditions: Sick preterm infants undergoing neonatal intensive care.; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2017-005091-26-SE
• Lead Sponsor: Skåne University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-22
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified