Clonidine for Analgesia to Preterm Infants During Neonatal Intensive Care

Region Skane

Status: Completed

Conditions: Intensive Care, Neonatal; Analgesia; Hypnotics and Sedatives

Treatments: Drug: Clonidine

Study type: Observational

Funder types: Other

Identifiers

NCT04928651

2017-005091-26

Details and patient eligibility

About

A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, in clonidine administered for analgesia and sedation to preterm newborn infants receiving neonatal intensive care. Phase 3 - therapeutic confirmatory study

Full description

All preterm infants that are admitted to the study neonatal intensive care units (NICUs) for neonatal intensive care are potential study patients, and their parents will be asked for consent.

The patient will be treated according to clinical guidelines and will be included in the study if in need for clonidine according to clinical judgment (pain scores) and as decided by the responsible clinical doctor. The dosing and administration of the drug will be implemented according to an algorithm based on pain scoring results.

Apart from extra blood sampling, the bedside monitoring, investigations (electroencephalography, EEG, echocardiography, ECG, ultrasound of the brain) and follow-up (neurologic examination and magnetic resonance imaging, MRI) are the same as for all preterm infants according to local and national guidelines.

In total 100 infants will be included.

Enrollment: 40 patients

Sex: All

Ages: Under 37 weeks old

Volunteers: No Healthy Volunteers

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

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.

Trial design

40 participants in 1 patient group

Clonidine

Description:

Preterm infants (\< gw 37+0) who are in need for analgesic or sedative medication will receive treatment with clonidine according to an algorithm based on pain and sedative scoring results

Treatment:

Drug: Clonidine