Pharmacokinetics and Pharmacodynamics of Medication in Asphyxiated Newborns During Controlled Hypothermia PharmaCool National Multicenter Study.

Pharmacokinetics and Pharmacodynamics of Medication in Asphyxiated Newborns During Controlled Hypothermia PharmaCool National Multicenter Study. - PharmaCool National Multicenter Study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34433

Enrollment

270

Registered

2011-01-21

Start date

2011-01-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

medication metabolism during the intensive care treatment of resuscitated newborns

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion 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 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

Exclusion criteria

Exclusion criteria: 1) congenital hepatic or renal pathology (as this makes interpretation of PKPD results impossible); 2) without central venous line or arterial bloodstream access for blood sampling; 3) without written parental consent to participate following informed consent interview.

Design outcomes

Primary

Measure	Time frame
Primary study outcomes: 1) PK properties of three groups of drugs in a prospective cohort of patients: Group I: Antibiotic medications Group II: Analgesic medications Group III:Sedative and anti-epileptic drugs 2) PD parameters : -anti-epileptic drugs: successful seizure control (anti-epileptics), -sedative drugs: measuring newborn stress using the Comfort Scale. -antibiotics: adequate treatment of perinatal infection shown by negative repeat blood culture, normalisation of C-reactive protein and leukocyte counts (antibiotics), - determination of the MIC -value of cultured microorganisms to evaluate antibiotic susceptibility -or resistance. 3) possible side effects:(e.g. gentamyxcin) -(acute) drug effects on end organs such as liver, kidney, bone marrow, -(long-term outcome) hearing screening at 3 months of age including the ALGO newborn hearing screening.	—

Measure

Time frame

Primary study outcomes: 1) PK properties of three groups of drugs in a prospective cohort of patients: Group I: Antibiotic medications Group II: Analgesic medications Group III:Sedative and anti-epileptic drugs 2) PD parameters : -anti-epileptic drugs: successful seizure control (anti-epileptics), -sedative drugs: measuring newborn stress using the Comfort Scale. -antibiotics: adequate treatment of perinatal infection shown by negative repeat blood culture, normalisation of C-reactive protein and leukocyte counts (antibiotics), - determination of the MIC -value of cultured microorganisms to evaluate antibiotic susceptibility -or resistance. 3) possible side effects:(e.g. gentamyxcin) -(acute) drug effects on end organs such as liver, kidney, bone marrow, -(long-term outcome) hearing screening at 3 months of age including the ALGO newborn hearing screening.

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Secondary

Measure	Time frame
FOLLOW-UP Long term follow-up in these asphyxiated neonates is part of the standard care protocol of the Dutch Working Group of Neonatal follow-up (L.N.F.). Data are collected outside the scope of this project. Long term outcome by neurodevelopmental testing at the ages of 6 months, 1 and 2 years will be related to neonatal pharmacological and clinical data.	—

Countries

Netherlands

Outcome results