ANZCTR - Registration

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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 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]

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

Local anaesthesia toxicity

Need of major surgery in the neonatal period.

Condition category

Condition code

Anaesthesiology

Pain management

Anaesthesiology

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Alpha-1-acid-glycoprotein levels before and after major surgery in newborns using a blood sample.

Timepoint [1]

Baseline (pre operatively), 12, 24,48 and 72 hours postoperatively.

Secondary outcome [1]

Nil

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Sweden

State/province [1]

Stockholm

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Karolinska University Hospital

Address [1]

Karolinska University Hospital
Eugeniavägen 23
171 64
Stockholm
Sweden

Country [1]

Sweden

Funding source category [2]

Charities/Societies/Foundations

Name [2]

HKH Kronprinsessan Lovisas förening

Address [2]

Scheelegatan 12

112 28 Stockholm

Country [2]

Sweden

Primary sponsor type

Hospital

Name

Karolinska University Hospital , Region Stockholm

Address

Eugeniavägen 23
171 64
Stockholm
Sweden

Country

Sweden

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Regional Ethics committee Stockholm

Ethics committee address [1]

Tomtebodavägen 18A
171 65
Stockholm

Ethics committee country [1]

Sweden

Date submitted for ethics approval [1]

04/03/2013

Approval date [1]

19/02/2014

Ethics approval number [1]

2014/64-31/2

Ethics committee name [2]

regional Ethics committee Stockholm

Ethics committee address [2]

Tomtebodavägen 18A
171 65
Stockholm

Ethics committee country [2]

Sweden

Date submitted for ethics approval [2]

Approval date [2]

22/05/2019

Ethics approval number [2]

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

Dr Marie Anell Olofsson

Address

Paediatric Intensive Care unit , F6:33
Eugeniavägen 23
171 64
Stockholm

Country

Sweden

Phone

+46851772690

Fax

[email protected]

Contact person for public queries

Name

Marie Anell Olofsson

Address

Paediatric Intensive Care unit , F6:33
Eugeniavägen 23
171 64
Stockholm

Country

Sweden

Phone

+468517772690

Fax

[email protected]

Contact person for scientific queries

Name

Marie Anell Olofsson

Address

Paediatric Intensive Care unit , F6:33
Eugeniavägen 23
171 64
Stockholm

Country

Sweden

Phone

+468517772690

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		17 April 2023 Linnarsson C, Bartocci M, Larsson B... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Alpha-1-acid glycoprotein and its potential impact on local anesthetic dose in neonates.	2023	https://dx.doi.org/10.1111/pan.14672

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically