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Variations of the acute phase protein Alpha-1-acid glycoprotein in newborns going through major surgery.

Alteration of levels of alpha-1-acid-glycoprotein as a response to major surgery in newborns.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000159752
Enrollment
25
Registered
2022-01-31
Start date
2019-05-22
Completion date
2020-10-08
Last updated
2022-02-07

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

Conditions

None listed

Brief summary

Alpha-1-acid-glycoprotein (AAGP) binds hard to local anaesthetics (LA) therefore altering the free fraction of the same. Since the free fraction of LA stands for both effectiveness and toxicity, it is important to know which level of AAGP new-born infants have before and after major surgery. This study is a complement to our previous study, which showed that vaginally born babies had significantly higher concentrations of AAGP than those born with caesarean section. This has implications alongside with other factors when discussing dosing of local anaesthetics in new-borns. The aim of this prospective observational study is to measure the levels of AAGP before and after major surgery in new-born children, in relation to safe dosing of local anaesthetics in this patient category.

Interventions

A single blood sample of 0,5 ml will be collected from already indwelling arterial or venous lines at the same time as other samples are needed for clinical reasons. Pain will be assessed according to normal protocol every 3rd hour. This is done by observation of the patient. Blood samples will be collected preoperatively (<24 h before surgery) and after 12, 24, 48 and 72 hours post-surgery. Overall duration of study participation is 72 hours except for the surgeons control of the wound at

A single blood sample of 0,5 ml will be collected from already indwelling arterial or venous lines at the same time as other samples are needed for clinical reasons. Pain will be assessed according to normal protocol every 3rd hour. This is done by observation of the patient. Blood samples will be collected preoperatively (<24 h before surgery) and after 12, 24, 48 and 72 hours post-surgery. Overall duration of study participation is 72 hours except for the surgeons control of the wound at discharge from hospital (does not differ from normal routine) The observations will be performed by the ICU nurse tending the patient (pain assessment) , the surgeon (wound observation) and the study researcher (collecting blood samples). The number of blood samples collected post surgery can be prematurely completed if the indwelling lines stops to work. No separate punctures are allowed. During the study time other clinical samples also will be checked according to normal routine. We are going to look att C reactive protein levels but no separate samples of this will be taken for the study.

Sponsors

Karolinska University Hospital , Region Stockholm
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
No minimum to 3 Months
Healthy volunteers
No

Inclusion criteria

Age < 3 months infants undergoing major surgery.

Exclusion criteria

The need of extracorporeal membrane oxygenation (ECMO) or suspected severe genetic disorder.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026