Extreme Prematurity,Extremely Low BirthweightNCT05022433
Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates
An observational study of Extreme Prematurity,Extremely Low Birthweight and Extremely Low Birth Weight, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959. It is a suitable method for parenteral nutrition access and medications administration. Read more about this study
- Who is it for?
- Ages 0 to 30 days
- Conditions the study is for
- Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight, Very Low Birth Weight Infant
- What is being tested?
- UVC insertion
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Jun 2019to 11 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: All term and preterm newborns admitted in Singapore General Hospital requiring UVC insertion with no major congenital malformation will be included in the study.
Who may be able to join
- All term and preterm newborns requiring UVC insertion will be included in the study.
Who cannot join
- All neonates with major congenital malformations that interferes with the placement of the UVC will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates: A Randomized Clinical Study
Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959. It is a suitable method for parenteral nutrition access and medications administration. Despite the benefits of the UVC, its potential complications must be considered. Thus, it is vital to determine the appropriate penetration length of the UVC.
Read the detailed description
UVC insertion has benefits and potential complications such as infection, intestinal necrosis, thrombosis, ascites, hydrothorax, cardiac tamponade, cardiac arrhythmias, pleural effusion, pericarditis and pericardial effusion. The complications may be due to insertion of catheter in an inappropriate location. Imaging procedures such as plain thoracoabdominal x-ray is needed after catheter insertion to specify the location of the catheter tip. In addition to preventing complications, insertion of umbilical venous catheter in an appropriate location is essential for umbilical catheterisation effectiveness. There are different methods to determine the length of catheter which must be inserted in umbilical vessels. The UVC formulae are based on either body surface measurement such as Dunn method, Umbilical to Intermammary Distance (UIMD), Umbilical to Nipple Distance (UN)-1 and birthweight based formula method such as Shukla and Modified Shukla. Shukla and UN-1 Methods have been widely used in the world. However, the accuracy of these two methods in estimating the length of umbilical venous catheter has not still demonstrated.
- Conditions
- Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight, Very Low Birth Weight Infant, Neonatal Hypoglycemia
- Being tested
- UVC insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVC insertionProcedure or surgery
To compare two formulae namely UN-1 and Shukla method to estimate the UVC insertion length in achieving optimum UVC tip position.
| Study group | Role | What they receive |
|---|---|---|
| Shukla | Shukla is a birth weight based formula to determine the insertional depth of the UVC Receives: Procedure: UVC insertion | |
| UN-1 | UN-1 is a body surface based formula to determine the insertional depth of the UVC Receives: Procedure: UVC insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study
Using the chest and abdominal X-ray, the distance of the UVC tip position in reference to the diaphragm level is measured.UVC tip position is then labeled as either IDEAL,SHORT or DEEP position. Ideal position is defined as the UVC tip is at the diaphragm level or +/- 0.5cm distance from the diaphragm. Short UVC is defined if the UVC tip is >0.5 cm below the diaphragm.Deep UVC position is defined as if the UVC tip is > 0.5cm above the diaphragm.
Measured: 14 days
Secondary outcomes (1)
Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study
Using the chest and abdominal X-ray, the distance of the UVC tip position in reference between the upper border of T9 to the lower border of T10 level is measured. UVC tip position is then labeled as IDEAL, SHORT and DEEP UVC position.Ideal position is defined as the UVC tip position in between the level of the upper border of T9 to the lower border of T10. Short UVC if the tip is below the lower border of T10. Deep UVC position is defined as the UVC tip above the upper border of T9.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start6 Jun 2019
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extreme Prematurity,Extremely Low BirthweightStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARY GRACE S TAN, MD, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022433
- Sponsor's protocol ID
- 2019-2300
- Status last verified
- Dec 2023
- First submitted
- 9 Aug 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05022433
- Acronym / sponsor ID
- 2019-2300
- Conditions
- Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight, Very Low Birth Weight Infant, Neonatal Hypoglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959. It is a suitable method for parenteral nutrition access and medications administration. Despite the benefits of the UVC, its potential complications must be considered. Thus, it is vital to determine the appropriate penetration length of the UVC.
Detailed description
UVC insertion has benefits and potential complications such as infection, intestinal necrosis, thrombosis, ascites, hydrothorax, cardiac tamponade, cardiac arrhythmias, pleural effusion, pericarditis and pericardial effusion. The complications may be due to insertion of catheter in an inappropriate location. Imaging procedures such as plain thoracoabdominal x-ray is needed after catheter insertion to specify the location of the catheter tip. In addition to preventing complications, insertion of umbilical venous catheter in an appropriate location is essential for umbilical catheterisation effectiveness. There are different methods to determine the length of catheter which must be inserted in umbilical vessels. The UVC formulae are based on either body surface measurement such as Dunn method, Umbilical to Intermammary Distance (UIMD), Umbilical to Nipple Distance (UN)-1 and birthweight based formula method such as Shukla and Modified Shukla. Shukla and UN-1 Methods have been widely used in the world. However, the accuracy of these two methods in estimating the length of umbilical venous catheter has not still demonstrated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shukla | – | Procedure: UVC insertionShukla is a birth weight based formula to determine the insertional depth of the UVC |
| UN-1 | – | Procedure: UVC insertionUN-1 is a body surface based formula to determine the insertional depth of the UVC |
Who may qualify
- Ages
- 0 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All term and preterm newborns admitted in Singapore General Hospital requiring UVC insertion with no major congenital malformation will be included in the study.
Key inclusion criteria (1 listed)
- All term and preterm newborns requiring UVC insertion will be included in the study.
Key exclusion criteria (1 listed)
- All neonates with major congenital malformations that interferes with the placement of the UVC will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UVC insertionTo compare two formulae namely UN-1 and Shukla method to estimate the UVC insertion length in achieving optimum UVC tip position. | Procedure or surgery | Shukla, UN-1 |
Primary outcome
Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study
Time frame: 14 days
Using the chest and abdominal X-ray, the distance of the UVC tip position in reference to the diaphragm level is measured.UVC tip position is then labeled as either IDEAL,SHORT or DEEP position. Ideal position is defined as the UVC tip is at the diaphragm level or +/- 0.5cm distance from the diaphragm. Short UVC is defined if the UVC tip is >0.5 cm below the diaphragm.Deep UVC position is defined as if the UVC tip is > 0.5cm above the diaphragm.
1 secondary outcome
Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARY GRACE S TAN, MD principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extreme Prematurity,Extremely Low Birthweight and Extremely Low Birth Weight, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.