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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]

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

Condition category

Condition code

Other

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]

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]

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]

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]

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]

Within two weeks of insertion.

Secondary outcome [2]

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]

Within two weeks of PICC insertion

Secondary outcome [3]

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]

Within two weeks of PICC insertion

Secondary outcome [4]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Pahang and Kelantan

Country [2]

Malaysia

State/province [2]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Research Management Centre, International Islamic University Malaysia

Address [1]

Jalan Sultan Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang

Country [1]

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]

University

Name [1]

Universiti Sains Malaysia

Address [1]

Jalan Raja Perempuan Zainab 2,
Kota Bharu, 16150, Kelantan

Country [1]

Malaysia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

IIUM Research Ethics Committee

Ethics committee address [1]

Research Management Centre, Level 1, Block 2, Office of the Campus Director, IIUM Kuantan Campus

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

19/08/2020

Approval date [1]

19/10/2020

Ethics approval number [1]

IREC2020-122

Summary

Brief summary

A PICC (peripherally inserted central catheter) is a catheter in which the tip resides in a central vein via percutaneous insertion from a peripheral vein. A neonatal PICC can be inserted at the patient's bedside and it can remain in place for several weeks. The small diameter of its lumen is ideal for the extremely small neonate. However, the placement and maintenance of peripheral intravenous catheters in preterm infants is difficult and can become a challenge for clinicians. The complications of PICC placement have been previously reported as infection, thrombosis, phlebitis, bleeding and misplacement. The complication rate of PICCs is associated with the location of their tips. Centrally placed catheter tips are associated with fewer complications compared with non-centrally placed catheter tips (Jumani, Advani et al. 2013). Therefore, the tip location of PICC is an important factor in reducing the complication rate of PICC. The determination of PICC insertion length traditionally depends on the direct measurement of length between two anatomical landmarks on the infant's body. In 2019, Chen et. al. introduced a mathematical formula to determine the PICC insertion length using anthropometric measurement.

This study aims to recruit 72 infants less with a birth weight of less than 1500g that will be randomised into either the mathematical formula or direct measurement method in the insertion length determination. The outcomes will include the proportion of infants with appropriate PICC tip placement and rate of complication within the first two weeks post insertion. 

We hypothesized that determination of the length of insertion of PICC in neonates using mathematical formula based on body measurement has higher successful rate with lower rate of complication compared to direct measurement.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Muhd Alwi in Muhd Helmi

Address

Department Of Pediatric. Kulliyah Of Medicine, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang

Country

Malaysia

Phone

+6095914542

Fax

muhdalwi@iium.edu.my

Contact person for public queries

Name

Muhd Alwi in Muhd Helmi

Address

Department Of Pediatric. Kulliyah Of Medicine, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang

Country

Malaysia

Phone

+6095914542

Fax

muhdalwi@iium.edu.my

Contact person for scientific queries

Name

Muhd Alwi in Muhd Helmi

Address

Department Of Pediatric. Kulliyah Of Medicine, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang

Country

Malaysia

Phone

+6095914542

Fax

muhdalwi@iium.edu.my

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 muhdalwi@iium.edu.my (Dr Muhd Alwi-Principal Investigator).

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10952	Informed consent form			muhdalwi@iium.edu.my		380337-(Uploaded-01-08-2021-20-05-01)-Study-related document.pdf
12756	Study protocol					380337-(Uploaded-04-08-2021-12-10-46)-Study-related document.docx

Results publications and other study-related documents

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No additional documents have been identified.

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