Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000331538
Ethics application status
Approved
Date submitted
21/12/2023
Date registered
25/03/2024
Date last updated
25/03/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized Control Trial on Short Term Effect of High versus Low Position of Umbilical Catheter in Neonates
Scientific title
A randomised controlled trial investigating the incidence of short-term complications between high- versus low-position of umbilical catheters in neonates.
Secondary ID [1] 311238 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic thrombosis 332446 0
Peripheral vascular compromise 332447 0
Intraventricular haemorrhage 332448 0
Necrotising enterocolitis 332449 0
Hypertension 332450 0
Haematuria 332451 0
Acute kidney injury 332452 0
neonatal umbilical artery catheter 333019 0
Condition category
Condition code
Cardiovascular 329138 329138 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 329140 329140 0 0
Other neurological disorders
Oral and Gastrointestinal 329141 329141 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 329142 329142 0 0
Hypertension
Reproductive Health and Childbirth 329707 329707 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High-position umbilical artery catheter(UAC) is the intervention treatment.
The high-position UAC is placed within the thoracic aorta between T6 to T10 with positioning confirmed via radiological imaging (chest & abdominal x-ray)
Neonatologist or neonatal unit medical officer incharged of NICU will do the high position UAC insertion
There will be audit of medical records to monitor adherence to the intervention.
Intervention code [1] 327695 0
Treatment: Other
Comparator / control treatment
Low-position umbilical artery cathter(UAC) is the control treatment.
The low-position UAC is placed within the abdominal aorta between L3 to L5 with positioning confirmed via radiological imaging (chest & abdominal x-ray)
Neonatologist or neonatal unit medical officer incharged of NICU will do the low position UAC insertion
There will be audit of medical records to monitor adherence to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 336973 0
acute kidney injury
Timepoint [1] 336973 0
frequency of assessment will be day 1 of umbilical artery catheter insertion, day 7 of life and day 14 of life.
Primary outcome [2] 337498 0
aortic thrombosis
Timepoint [2] 337498 0
frequency of assessment will be day 1 of umbilical artery catheter insertion, day 7 of life and day 14 of life.
Primary outcome [3] 337499 0
intraventricular haemorrhage .
Timepoint [3] 337499 0
frequency of assessment will be day 1 of umbilical artery catheter insertion,day 7 of life and day 14 of life
Secondary outcome [1] 432136 0
Complications following UAC position readjusment- aortic thrombosis, acute kidney injury and intraventricular hemorrhage
Timepoint [1] 432136 0
frequency of assessment will be day 1 of umbilical artery catheter insertion, day 7 and day 14 of life
Secondary outcome [2] 432137 0
Rate of complications based on duration of UAC in-situ
Timepoint [2] 432137 0
frequency of assessment will be day 1 of umbilical artery catheter insertion, day 7 and day 14 of life

Eligibility
Key inclusion criteria
1) Patients who requiring umbilical artery catheter insertion
2) All term and preterm babies with gestational age equal to or more than 24 weeks
3) All term and preterm babies with weight more than 500g
Minimum age
No limit
Maximum age
14 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Umbilical cord infection- Omphalitis
2) Newborn with major congenital abnormalities
3) Clinical evidence or suspected abdominal wall and viscera infection such as necrotizing enterocolitis or peritonitis.
4) Newborn with hematuria secondary to urinary tract infection
5) Breech presentation with lower limbs bruises

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sequentially numbered, opaque, sealed and stapled envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 26052 0
Malaysia
State/province [1] 26052 0

Funding & Sponsors
Funding source category [1] 315495 0
University
Name [1] 315495 0
Hospital Universiti Sains Malaysia
Country [1] 315495 0
Malaysia
Primary sponsor type
University
Name
Hospital Universiti Sains Malaysia
Address
Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan, Malaysia
Country
Malaysia
Secondary sponsor category [1] 317570 0
None
Name [1] 317570 0
Address [1] 317570 0
Country [1] 317570 0
Other collaborator category [1] 282900 0
Individual
Name [1] 282900 0
Associate Professor Dr Noraida Ramli
Address [1] 282900 0
Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan, Malaysia
Country [1] 282900 0
Malaysia
Other collaborator category [2] 282901 0
Individual
Name [2] 282901 0
Dr Farohah Che Mat Zain
Address [2] 282901 0
Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan, Malaysia
Country [2] 282901 0
Malaysia
Other collaborator category [3] 282902 0
Individual
Name [3] 282902 0
Dr Nor Rosidah Ibrahim
Address [3] 282902 0
Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan, Malaysia
Country [3] 282902 0
Malaysia
Other collaborator category [4] 282903 0
Individual
Name [4] 282903 0
Dr Anis Munirah Mohd Kori
Address [4] 282903 0
Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan, Malaysia
Country [4] 282903 0
Malaysia
Other collaborator category [5] 282904 0
Individual
Name [5] 282904 0
Dr Kueh Yee Cheng
Address [5] 282904 0
Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan, Malaysia
Country [5] 282904 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314398 0
JEPeM-USM
Ethics committee address [1] 314398 0
Ethics committee country [1] 314398 0
Malaysia
Date submitted for ethics approval [1] 314398 0
01/07/2023
Approval date [1] 314398 0
26/10/2023
Ethics approval number [1] 314398 0
USM/JEPeM/KK/23060438

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131442 0
Dr Lee Ling Hong
Address 131442 0
Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan
Country 131442 0
Malaysia
Phone 131442 0
+60124085030
Fax 131442 0
Email 131442 0
[email protected]
Contact person for public queries
Name 131443 0
Lee Ling Hong
Address 131443 0
Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan
Country 131443 0
Malaysia
Phone 131443 0
+60124085030
Fax 131443 0
Email 131443 0
[email protected]
Contact person for scientific queries
Name 131444 0
Lee Ling Hong
Address 131444 0
Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan
Country 131444 0
Malaysia
Phone 131444 0
+60124085030
Fax 131444 0
Email 131444 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21279Ethical approval    Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.