Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001565831
Ethics application status
Approved
Date submitted
9/03/2021
Date registered
17/11/2021
Date last updated
2/11/2022
Date data sharing statement initially provided
17/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Method for Determination of Peripherally Inserted Central Catheter (PICC) Insertion Length in Infants
Scientific title
Proportion of Successful Insertions in Mathematical Formula versus Direct Measurement for Insertion of Peripherally Inserted Central Catheter (PICC) in Neonates (PICCIN)
Secondary ID [1] 301972 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Misplacement of peripherally inserted central catheter in neonates 318579 0
Condition category
Condition code
Other 316595 316595 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For neonates randomized into intervention group, the length of PICC insertion will be based on the formula;

Length (cm) = -1.45 + (0.36 x body length (cm))

All PICC will be inserted by a well-trained medical officers working in NICUs with at least one year experiences in PICC insertion. All the medical officers (MO) will be trained on the correct method to measure the length from the insertion site to the sternal notch.

Intervention code [1] 318309 0
Treatment: Other
Comparator / control treatment
Infants in the control group will have the length of PICC based on direct measurement of the length between the PICC insertion site to sternal notch.
Control group
Active

Outcomes
Primary outcome [1] 324798 0
The proportion of successful PICC insertion; defined as the correct placement of PICC tip without the need for readjustment. This will be assessed by two blinded consultant neonatologist, by reviewing the chest and/or abdominal radiograph. Correct placement is confirmed if the catheter tip; resides within the superior vena cava but above the level of T4 Outcomes will be divided into two categories; correctly placed or incorrectly placed PICC. All radiographs will be submitted to the research coordinator before submission to the blinded assessors. Any dispute among the assessor will be solve by seeking opinion from another independent assessor outside the research team.
Timepoint [1] 324798 0
The determination of the tip position by the blinded outcome assessors will not affect the clinical care of the participants. The outcome will be assessed possibly within the first 24 hours after the PICC insertion.
Secondary outcome [1] 385577 0
Secondary outcomes include the proportion of PICC that develop any complication attributable to the initial misplacement of the catheter tip. All secondary outcomes will be measured by the neonatologist managing the infants in the NICU.
Timepoint [1] 385577 0
Within two weeks of insertion.
Secondary outcome [2] 392690 0
The rate of removal of PICC due to complications,

Every steps in PICC insertion will be documented together with details description on the method of insertion length measurement, size of the catheter, and the exact site and length of insertion of the PICC. Any immediate and post insertion complication such as arrhythmia and trauma and daily monitoring and assessment for development of delayed complications in the next two weeks post PICC insertion will also be documented by the investigator. Only research researchers can access the data to ensure confidentiality and to prevent bias. Data will be presented as grouped data and will not identify individual subject. Unit of analysis of this study is the recruited infant.
Timepoint [2] 392690 0
Within two weeks of PICC insertion
Secondary outcome [3] 392691 0
The mean number of PICC readjustment when PICC is inserted using mathematical formula compared to by direct measurement

Every steps in PICC insertion will be documented together with details description on the method of insertion length measurement, size of the catheter, and the exact site and length of insertion of the PICC. Any immediate and post insertion complication such as arrhythmia and trauma and daily monitoring and assessment for development of delayed complications in the next two weeks post PICC insertion will also be documented by the investigator. Only research researchers can access the data to ensure confidentiality and to prevent bias. Data will be presented as grouped data and will not identify individual subject. Unit of analysis of this study is the recruited infant.
Timepoint [3] 392691 0
Within two weeks of PICC insertion
Secondary outcome [4] 392692 0
The number of complications includes arrhythmia, thrombosis, pleural and pericardial effusion, extravasation, catheter rupture, and catheter displacement.

Every steps in PICC insertion will be documented together with details description on the method of insertion length measurement, size of the catheter, and the exact site and length of insertion of the PICC. Any immediate and post insertion complication such as arrhythmia and trauma and daily monitoring and assessment for development of delayed complications in the next two weeks post PICC insertion will also be documented by the investigator. Only research researchers can access the data to ensure confidentiality and to prevent bias. Data will be presented as grouped data and will not identify individual subject. Unit of analysis of this study is the recruited infant.
Timepoint [4] 392692 0
Within the first two weeks of PICC insertion

Eligibility
Key inclusion criteria
Infants weigh equal or less than 1500g admitted to NICU that require PICC insertion in the participating NICUs within the study the period.
Minimum age
1 Days
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Congenital anomaly that is expected to interfere with study outcome as listed;
-Orthopaedic problems: Arthrogryposis multiplex congenita, fixed congenital talipes equinovarus, development dysplasia of the hip (DDH), skeletal dysplasia,
2. Chromosomal aneuploidy or genetic disorders : Any recognized or unrecognized dysmorphism , i.e. Down Syndrome, Patau Syndrome, Edward Syndrome, Single gene or polygenic defects, ie: Cri-du chat, Di George syndrome, Prader Willi Syndrome etc
3. Patient with vascular anomaly
4. Hydrops fetalis

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited by the investigators, and only after inclusion in the study, consecutively numbered, sealed and opaque envelopes, carrying the allocation number will be opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No sampling will be used in this study. All infants admitted that fulfilled the inclusion and exclusion criteria will be included in the study. The random sequence will be generated by a research coordinator who is not involved in the recruitment of patients, neither in the data collection nor care of the NICU patients using variable block randomization known only to that person.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For inter-observer reliability, we will use Bland-Altman plot analysis. Two MOs will be asked to measure the PICC insertion length of an infant. The procedure will be repeated on 10 infants. The difference of the two paired measurements is plotted against the mean of the two measurements. We will accept if all the plot lies within 95% CI of agreement limits. We will be using correlation analysis to determine intra-observer reliability. Ten babies and a random MO will be chosen. The MO will measure the insertion length of the PICC twice within 6 hours period and correlation coefficient (r) value will be measured. ‘r’ value of >0.8 is acceptable. Other steps of PICC insertion including the type of antiseptic solution, the dressing that will be used and post insertion care and maintenance will be according to the standard care in NICU.

For standardisation of the length measurement of the infants, we will use the same scale in both centres. Length is measured from tip of head until the bottom of one of the heel in lying position. All nurses working in all the participating NICUs will be trained on the correct method of length measurement. Similar intra and inter-observer reliability assessment will be conduct after the training session. Training session will be repeated until optimal reliability is achieved.

Data will be entered and analysed using SPSS version 24. The demographic and numerical data will be presented by mean (SD) and median (IQR) according to data distribution. The categorical data will be expressed as number and percentage. P-value = 0.05% will be considered statistically significant. Chi Squared Test or Fisher-exact test will be used to compare the proportion of successful PICC insertion, the proportion of catheter that end up with complication attributed to the misplacement of the catheter or the readjustment procedure, and the proportion of catheter removed due to complication. Independent t-test or Mann-Whitney Test will be used to compare the mean number for readjustment attempted in both groups depending on the distribution of the data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
19/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
35
Final
Recruitment outside Australia
Country [1] 22825 0
Malaysia
State/province [1] 22825 0
Pahang and Kelantan
Country [2] 24022 0
Malaysia
State/province [2] 24022 0

Funding & Sponsors
Funding source category [1] 306395 0
University
Name [1] 306395 0
Research Management Centre, International Islamic University Malaysia
Country [1] 306395 0
Malaysia
Primary sponsor type
University
Name
International Islamic University Malaysia
Address
Jalan Sultan Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang
Country
Malaysia
Secondary sponsor category [1] 308807 0
University
Name [1] 308807 0
Universiti Sains Malaysia
Address [1] 308807 0
Jalan Raja Perempuan Zainab 2,
Kota Bharu, 16150, Kelantan
Country [1] 308807 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306597 0
IIUM Research Ethics Committee
Ethics committee address [1] 306597 0
Ethics committee country [1] 306597 0
Malaysia
Date submitted for ethics approval [1] 306597 0
19/08/2020
Approval date [1] 306597 0
19/10/2020
Ethics approval number [1] 306597 0
IREC2020-122

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

Contacts
Principal investigator
Name 104406 0
Dr Muhd Alwi in Muhd Helmi
Address 104406 0
Department Of Pediatric. Kulliyah Of Medicine, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang
Country 104406 0
Malaysia
Phone 104406 0
+6095914542
Fax 104406 0
Email 104406 0
[email protected]
Contact person for public queries
Name 104407 0
Muhd Alwi in Muhd Helmi
Address 104407 0
Department Of Pediatric. Kulliyah Of Medicine, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang
Country 104407 0
Malaysia
Phone 104407 0
+6095914542
Fax 104407 0
Email 104407 0
[email protected]
Contact person for scientific queries
Name 104408 0
Muhd Alwi in Muhd Helmi
Address 104408 0
Department Of Pediatric. Kulliyah Of Medicine, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang
Country 104408 0
Malaysia
Phone 104408 0
+6095914542
Fax 104408 0
Email 104408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
trial outcomes and raw data
When will data be available (start and end dates)?
upon trial completion up until 3 years post-publication
Available to whom?
anyone interested including laypeople
Available for what types of analyses?
all analyses
How or where can data be obtained?
upon request by email to [email protected] (Dr Muhd Alwi-Principal Investigator).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10952Informed consent form  [email protected] 380337-(Uploaded-01-08-2021-20-05-01)-Study-related document.pdf
12756Study protocol    380337-(Uploaded-04-08-2021-12-10-46)-Study-related document.docx



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.