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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005091-26-SE

Enrollment

100

Registered

2017-12-22

Start date

2018-02-13

Completion date

Unknown

Last updated

2018-02-26

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

Conditions

Sick preterm infants undergoing neonatal intensive care.

Interventions

Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Catapresan Other descriptive name: CLONIDINE HYDROCHLORIDE Concentration unit: µg/ml microgram(s)/millilitre Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Preterm infants (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The specific aims of this Project are to •study the PK of clonidine in preterm infants using NONMEM® (Nonlinear Mixed Effect Modelling) population based PK modelling. • assess the effects of the drug on brain function (PD) in these infants and relate the effects to drug concentration (PK/PD).;Secondary Objective: • assess the effects of the drug concentration (PK/PD) on to the physiological parameters (including NIRS) and relate the effects to drug concentration (PK/PD). • assess the pain response (pain assessment scales and GSR) in these infants and relate the effects to drug concentration (PK/PD). • develop a Swedish version of COMFORT-neo that is valid and culturally adapted • validate ALPS-Neo against behavioural and biomedical pain markers (Comfort-neo, GSR and S-cortisol) and determine whether a specific pharmacogenetic (PG) profile explains the PK and PD phenotypes of this drugs in newborn infants (PK/PD/PG). ;Primary end point(s): • Change in drug concentration (metabolism) relate to XXX • Effect of other medicines on clerance (including but not limited to phenobarbitone, midazolam, thiopentone). • Change in neurophysiology response in relation to PK;Timepoint(s) of evaluation of this end point: pre and until 72 h of treatment.	—

Measure

Time frame

Main Objective: The specific aims of this Project are to •study the PK of clonidine in preterm infants using NONMEM® (Nonlinear Mixed Effect Modelling) population based PK modelling. • assess the effects of the drug on brain function (PD) in these infants and relate the effects to drug concentration (PK/PD).;Secondary Objective: • assess the effects of the drug concentration (PK/PD) on to the physiological parameters (including NIRS) and relate the effects to drug concentration (PK/PD). • assess the pain response (pain assessment scales and GSR) in these infants and relate the effects to drug concentration (PK/PD). • develop a Swedish version of COMFORT-neo that is valid and culturally adapted • validate ALPS-Neo against behavioural and biomedical pain markers (Comfort-neo, GSR and S-cortisol) and determine whether a specific pharmacogenetic (PG) profile explains the PK and PD phenotypes of this drugs in newborn infants (PK/PD/PG). ;Primary end point(s): • Change in drug concentration (metabolism) relate to XXX • Effect of other medicines on clerance (including but not limited to phenobarbitone, midazolam, thiopentone). • Change in neurophysiology response in relation to PK;Timepoint(s) of evaluation of this end point: pre and until 72 h of treatment.

—

Secondary

Measure	Time frame
Secondary end point(s): •Change in/association between physiological parameters (heart rate (HR), mean arterial blood pressure (MABP, recorded invasively and, peripheral oxygen saturation (SpO2)) in relation to PK and other PD parameters. •Change in/association between pain responses as measured by pain assessment score for continuous pain/stress (ALPS-Neo and Comfort Neo) and GSR, in relation to PK and other PD. •Pain response as measured by pain assessment score ALPS-Neo and Comfort Neo in relation to GSR (=galvanic skin respons) •Change in S-Cortisol in relation to PK and PD and pain response at a standardized pain procedure performed at a stage of stability after 6 hours of unchanged medication, •How PK/PD phenotypes depend on pharmacogenetic (PG) profiles.;Timepoint(s) of evaluation of this end point: pre and until 72 h of treatment.	—

Measure

Time frame

Secondary end point(s): •Change in/association between physiological parameters (heart rate (HR), mean arterial blood pressure (MABP, recorded invasively and, peripheral oxygen saturation (SpO2)) in relation to PK and other PD parameters. •Change in/association between pain responses as measured by pain assessment score for continuous pain/stress (ALPS-Neo and Comfort Neo) and GSR, in relation to PK and other PD. •Pain response as measured by pain assessment score ALPS-Neo and Comfort Neo in relation to GSR (=galvanic skin respons) •Change in S-Cortisol in relation to PK and PD and pain response at a standardized pain procedure performed at a stage of stability after 6 hours of unchanged medication, •How PK/PD phenotypes depend on pharmacogenetic (PG) profiles.;Timepoint(s) of evaluation of this end point: pre and until 72 h of treatment.

—

Countries

Sweden

Contacts

Public ContactElisabeth Norman

Skåne University Hospital

Elisabeth.Norman@med.lu.se004646 171000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026