A prospective investigation into the role of therapeutic hypothermia on medication metabolism and excretion in newborns with perinatal resuscitation.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR2529
• Date of registration: 22/09/2010
• Primary sponsor: Academic Medical Center (AMC), Emma Children's Hospital
• Public title: A prospective investigation into the role of therapeutic hypothermia on medication metabolism and excretion in newborns with perinatal resuscitation.
• Scientific title: Pharmacokinetics and Pharmacodynamics of Medication in Asphyxiated Newborns During Controlled Hypothermia. PharmaCool National Multicenter Study. - PharmaCool
• Date of first enrolment: 1/1/2011
• Target sample size: 270
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2529
• Study type: observational
• Study design: Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: Single arm

Countries of recruitment

The Netherlands

Contacts

• Name: T.R. Haan, de

• Name: T.R. Haan, de

Key inclusion & exclusion criteria

Inclusion criteria: Any newborn :

1. With a gestational age > 36 weeks and a birth weight > 3 kg;

2. With Apgar Score at 5 minutes postnatal < 5;

3. With continued resuscitation at 10 minutes postnatally;

4. With 1 hour postnatal bloodgas analysis pH < 7.0 or base deficit > 16;

5. With clinical signs of moderate to severe encephalopathy (defined as a Thomson score of >7 or a Sarnat score of >1);

6. Who is undergoing neuroprotective treatment by controlled hypothermia < 6 hours postnatally.
Exclusion criteria: 1. Congenital hepatic or renal pathology (as this makes interpretation of PKPD results impossible);

2. Without central venous line and arterial bloodstream access for blood sampling;

3. Without written parental consent to participate following informed consent interview.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Perinatal asphyxia, Pharmacokinetics, Pharmacodynamics, Therapeutic hypothermia

Intervention(s)

N/A

Primary Outcome(s)

This project aims to develop an evidence based effective and "safe" dosing regimen for commonly used life saving medications used in the treatment of asphyxiated, critically ill newborns, undergoing therapeutic hypothermia.

Secondary Outcome(s)

Assessment of possible correlations between medication use during neuroprotective hypothermia and long term neurodevelopmental outcome.

Secondary ID(s)

40-41500-98-9002

Source(s) of Monetary Support

ZON-MW, The Netherlands Organization for Health Research and Development

Secondary Sponsor(s)

University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)