Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000159752
Ethics application status
Approved
Date submitted
20/09/2021
Date registered
31/01/2022
Date last updated
31/01/2022
Date data sharing statement initially provided
31/01/2022
Date results information initially provided
31/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Variations of the acute phase protein Alpha-1-acid glycoprotein in newborns going through major surgery.
Scientific title
Alteration of levels of alpha-1-acid-glycoprotein as a response to major surgery in newborns.
Secondary ID [1] 305298 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain in the neonatal period 323614 0
Local anaesthesia toxicity 323615 0
Need of major surgery in the neonatal period. 323617 0
Condition category
Condition code
Anaesthesiology 321151 321151 0 0
Pain management
Anaesthesiology 321906 321906 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 321712 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328943 0
Alpha-1-acid-glycoprotein levels before and after major surgery in newborns using a blood sample.
Timepoint [1] 328943 0
Baseline (pre operatively), 12, 24,48 and 72 hours postoperatively.
Secondary outcome [1] 403443 0
Nil
Timepoint [1] 403443 0
Nil

Eligibility
Key inclusion criteria
Age < 3 months infants undergoing major surgery.
Minimum age
No limit
Maximum age
3 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The need of extracorporeal membrane oxygenation (ECMO) or suspected severe genetic disorder.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/05/2019
Date of last participant enrolment
Anticipated
Actual
8/10/2020
Date of last data collection
Anticipated
Actual
11/10/2020
Sample size
Target
25
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 24116 0
Sweden
State/province [1] 24116 0
Stockholm

Funding & Sponsors
Funding source category [1] 309671 0
Hospital
Name [1] 309671 0
Karolinska University Hospital
Country [1] 309671 0
Sweden
Funding source category [2] 309704 0
Charities/Societies/Foundations
Name [2] 309704 0
HKH Kronprinsessan Lovisas förening
Country [2] 309704 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital , Region Stockholm
Address
Eugeniavägen 23
171 64
Stockholm
Sweden
Country
Sweden
Secondary sponsor category [1] 310689 0
None
Name [1] 310689 0
Address [1] 310689 0
Country [1] 310689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309439 0
Regional Ethics committee Stockholm
Ethics committee address [1] 309439 0
Tomtebodavägen 18A
171 65
Stockholm
Ethics committee country [1] 309439 0
Sweden
Date submitted for ethics approval [1] 309439 0
04/03/2013
Approval date [1] 309439 0
19/02/2014
Ethics approval number [1] 309439 0
2014/64-31/2
Ethics committee name [2] 309466 0
regional Ethics committee Stockholm
Ethics committee address [2] 309466 0
Tomtebodavägen 18A
171 65
Stockholm
Ethics committee country [2] 309466 0
Sweden
Date submitted for ethics approval [2] 309466 0
Approval date [2] 309466 0
22/05/2019
Ethics approval number [2] 309466 0
2019-02213 amendment

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114162 0
Dr Marie Anell Olofsson
Address 114162 0
Paediatric Intensive Care unit , F6:33
Eugeniavägen 23
171 64
Stockholm
Country 114162 0
Sweden
Phone 114162 0
+46851772690
Fax 114162 0
Email 114162 0
marie.anell-olofsson@sll.se
Contact person for public queries
Name 114163 0
Dr Marie Anell Olofsson
Address 114163 0
Paediatric Intensive Care unit , F6:33
Eugeniavägen 23
171 64
Stockholm
Country 114163 0
Sweden
Phone 114163 0
+468517772690
Fax 114163 0
Email 114163 0
marie.anell-olofsson@sll.se
Contact person for scientific queries
Name 114164 0
Dr Marie Anell Olofsson
Address 114164 0
Paediatric Intensive Care unit , F6:33
Eugeniavägen 23
171 64
Stockholm
Country 114164 0
Sweden
Phone 114164 0
+468517772690
Fax 114164 0
Email 114164 0
marie.anell-olofsson@sll.se

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Small observational study.
Protection of patient related data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4813Study results articleYes 17 April 2023 Linnarsson C, Bartocci M, Larsson B... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAlpha-1-acid glycoprotein and its potential impact on local anesthetic dose in neonates.2023https://dx.doi.org/10.1111/pan.14672
N.B. These documents automatically identified may not have been verified by the study sponsor.