Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body MeasurementsNCT07045506
Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurements: A Multicenter Randomized Clinical Trial
A study testing UVC insertion in people with Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurements, run by King Fahad Medical City at 1 site in Saudi Arabia.
Trial summary
Introduction: The current methods for estimating umbilical venous catheter (UVC) insertion depth, including the umbilical to nipple (Gupta) and the birth weight-based (modified Shukla) formula, have varying accuracy rates. Read more about this study
- Who is it for?
- Ages Up to 1 week
- Conditions the study is for
- Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurements
- What is being tested?
- UVC insertion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 8 Mar 2022to 8 Mar 2025
- Phase
- Interventional
- 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 Up to 1 week
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All neonates who require UVC insertion as part of their intensive care during their NICU admission
Who cannot join
- Any neonate where the UVC is medically contra-indicated like lower limb ischemia, omphalitis, umbilical bleeding, confirmed intra-vascular thrombosis or DIC.
- Neonates with hydrops fetalis, abdominal wall defects, congenital diaphragmatic hernia, major congenital heart disease, and declined to participate or insertion of UVC beyand one week .
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Second Cluster ( KFMC and Alyamama Hospital )
Riyadh, 12211
About this study
Introduction: The current methods for estimating umbilical venous catheter (UVC) insertion depth, including the umbilical to nipple (Gupta) and the birth weight-based (modified Shukla) formula, have varying accuracy rates.
Objectives: To compare the accuracy of UVC insertion length using the birth weight-based formula versus the surface measurement formula in determining the optimal UVC tip position.
Methods: A multicenter randomized clinical trial was conducted in the neonatal intensive care units (NICUs) of the Second Cluster in Al Riyadh (AL Yamama Hospital and King Fahad Medical City), King Salman Armed Forces Hospital in the Northwestern Region, Tabuk City, Saudi Arabia. Neonates requiring UVC insertion during their NICU admission were randomly assigned to one of two formulas: 1) the umbilicus to nipple distance in centimeters minus 1 (UN - 1) or 2) the modified Shukla weight-based formula in centimeters (3 × birth weight in kg + 9, divided by 2) to estimate the pre-insertion UVC depth and to determine the UVC tip position anteroposterior and lateral thoracoabdominal radiographs were taken and reviewed by a neonatologist, who was blinded to the group assignments. Data analysis was conducted using appropriate statistical methods, ensuring adherence to ethical standards.
Read the detailed description
I.Project Summary In this randomized clinical study, who are hospitalize in the neonatal intensive care unit pediatric department of King Salman Armed Forces Hospital Northwestern Region KSA Neonates who require umbilical venous catheter (UVC) insertion during their NICU admission will be randomized to one of the 2 formulas 1) umbilicus to the nipple in cm minus 1 (UN - 1) or 2) and birth weight based formula (1.5×birth weight (Kg) + 5.6) for estimation of the pre-insertion UVC depth. UVC will be inserted under sterile condition as per our unit protocol. Then to determine the UVC tip position, anteroposterior and lateral a thoracoabdominal radiograph will be taken.
II.Introduction Umbilical vessel catheterization of newborns was used for more than 60 years (1,2).The ideal position of UVC tip to decrease complications is outside the heart at the junction of inferior vena cava and right atrium (3). UVC related complications are mainly due to catheter malposition as pericardial effusions , cardiac tamponade and cardiac thrombus have been reported with UVCs whose tips lay within the heart (4). There is no definite rule describe how far umbilical catheters should be inserted in the umbilical vein; different methods including the Dunn method, Shukla-Ferrara, modified Shukla-Ferrara and umbilicus to the nipple formulae are used (5). Selection of the most correct methods is very important in terms of decreasing th risk and frequency of complications (6,7). IN KFMC NICU and Alyamah NICU and Pediatric department of King Salman Armed Forces Hospital Northwestern Region KSA , the most commonly used method for estimation of UVC insertion length is the birth weight based formula (3× birth weight (Kg) +9)/2. A recent retrospective study reported that 57% accuracy rate with birth weight based formula(8). In our units no audit done for accuracy rate of UVC dependent on birth weight based formula endpoint
The endpoint measurement of UVC tip determined by anteroposterior x ray (12,13) to check where is the tipe of UVC located that is used in our unit
III.Project Objectives
Research Questions: Does the estimating insertion depth using umbilicus to the nipple in cm minus 1 (UN - 1) formula more accurate than a birth weight-derived formula resulted in more correctly placed umbilical venues catheters.
Primary objective: to compare accuracy rate between UVC insertion length estimated by using 1)umbilicus to the nipple distance in cm minus 1 (UN - 1) formula and 2) Shukla's exact birth weight based formula (3× birth weight (Kg) +9)/2to determine optimum UVC tip position compared against the standard accepted level UVC tip at the level of the diaphragm or the upper border of the 9th and the lower border of the 10th thoracic vertebrae (T9-T10) on the anteroposterior and lateral X-ray Secondary objective: to compare the accuracy rate of UVC tip position between two formulae depend on appropriation of baby to gestational age (AGA, SGA, LGA) AGA: appropriate for gestational age (i.e birth weight between 10th and 90th percentile for gestational age); SGA: Small for gestational age (i.e. birth weight <10th percentile for gestational age); LGA: large for gestational age (i.e. birth weight >90th percentile for gestational age)
IV.Literature Survey/Background Insertion of umbilical venous catheters in newborns admitted to hospital in neonatal intensive care units (NICU) who are preterm or have severe morbidity is a commonly used method for Venus access to maintain fluid support , parenteral nutrition ,administration of blood products, , administration of antibiotic , exchange transfusion and investigations, as well as providing emergency intravenous access (9). Ideally, umbilical venous catheters are placed under guidance of imaging methods. However, umbilical venous catheters are placed without any imaging method in emergency cases in NICUs. This leads to frequent occurrence of malposition of UVC (10,11). The commonly used formulas to estimate the depth of umbilical catheter include a birth weight based formula proposed by Shukla and Ferrara and Dunn's shoulder to umbilical length graph. In our units in the neonatal intensive care unit of KFMC / Al Yamamh Hospital KSA , the most commonly used method for estimation of UVC insertion length is the exact birth weight based formula (3× birth weight (Kg) +9)/2)(14). A recent retrospective study reported a distance from base of umbilicus to nipple distance (UN)-1 cm formula consider best and most accurate insertion depth of UVC with accuracy rate of 84% compared with 57% accuracy rate with birth weight based formula(8). In the literature, few studies have compared the two methods in determining how far umbilical catheters should be inserted in the umbilical vein
- Conditions
- Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurements
- Being tested
- UVC insertion
- Keywords
- umbilical venous catheter ( UVC) , catheter placement, Gupta method, birth weight-based formula, neonatal intensive care unit, clinical trial,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVC insertionOther
UVC insertion was performed under sterile conditions according to the unit protocol by a senior NICU physician. For preterm deliveries, written informed consent was obtained from a parent before enrollment in the study. In emergency cases, where the neonate required immediate UVC insertion upon admission to the NICU, a waiver of informed consent was applied. In such instances, parents were informed as soon as possible about their infant's participation in the study, provided with written information, and asked for their consent to include their infant's data in the analysis, with the option to give consent via telephone if they were unable to be present in person.
After UVC insertion, anteroposterior and lateral thoracoabdominal radiographs were performed to verify the position of the UVC tip.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 UVC insertion depth estimated using the Umbilicus to Nipple distance (UN) minus 1 | Active comparator | Neonates who met the eligibility criteria were randomly assigned to one of two groups. Group 1 had their UVC insertion depth estimated using the Umbilicus to Nipple distance (UN) minus 1 cm formula (Gupta method), while Group 2 used the birth weight formula (3*wt +9)/2 (modified Shukla). Randomization was achieved using a computer-generated sequence, with allocation in blocks of four. The neonates were randomized in a 1:1 ratio. Initially, 184 infants were assessed for eligibility to participate in the study. Of these, 4 were excluded due to refusal to participate. The remaining 180 infants were randomly assigned to one of two intervention groups (the Gupta group or the modified Shukla group) in a 1:1 ratio. All infants in both groups received the allocated intervention, with no cases lost to follow-up or discontinuation of the intervention. Receives: Other: UVC insertion |
| Group 2 UVC insertion used the birth weight formula (3*wt +9)/2 (modified Shukla) | Active comparator | Neonates who met the eligibility criteria were randomly assigned to one of two groups. Group 1 had their UVC insertion depth estimated using the Umbilicus to Nipple distance (UN) minus 1 cm formula (Gupta method), while Group 2 used the birth weight formula (3*wt +9)/2 (modified Shukla). Randomization was achieved using a computer-generated sequence, with allocation in blocks of four. The neonates were randomized in a 1:1 ratio. Initially, 184 infants were assessed for eligibility to participate in the study. Of these, 4 were excluded due to refusal to participate. The remaining 180 infants were randomly assigned to one of two intervention groups (the Gupta group or the modified Shukla group) in a 1:1 ratio. All infants in both groups received the allocated intervention, with no cases lost to follow-up or discontinuation of the intervention. Receives: Other: UVC insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of correctly inserted UVC at optimum catheter tip position for each method
Measured: Within 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start8 Mar 2022
- Primary completion8 Aug 2024
- Study completion8 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body MeasurementsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fawzy Kamel Abdelhamid, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045506
- Sponsor's protocol ID
- 21-542
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurements: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07045506
- Acronym / sponsor ID
- 21-542
- Conditions
- Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurements
- Keywords
- umbilical venous catheter ( UVC) , catheter placement, Gupta method, birth weight-based formula, neonatal intensive care unit, clinical trial,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Mar 2025 (actual)
- First posted
- 1 Jul 2025 (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.
Introduction: The current methods for estimating umbilical venous catheter (UVC) insertion depth, including the umbilical to nipple (Gupta) and the birth weight-based (modified Shukla) formula, have varying accuracy rates.
Objectives: To compare the accuracy of UVC insertion length using the birth weight-based formula versus the surface measurement formula in determining the optimal UVC tip position.
Methods: A multicenter randomized clinical trial was conducted in the neonatal intensive care units (NICUs) of the Second Cluster in Al Riyadh (AL Yamama Hospital and King Fahad Medical City), King Salman Armed Forces Hospital in the Northwestern Region, Tabuk City, Saudi Arabia. Neonates requiring UVC insertion during their NICU admission were randomly assigned to one of two formulas: 1) the umbilicus to nipple distance in centimeters minus 1 (UN - 1) or 2) the modified Shukla weight-based formula in centimeters (3 × birth weight in kg + 9, divided by 2) to estimate the pre-insertion UVC depth and to determine the UVC tip position anteroposterior and lateral thoracoabdominal radiographs were taken and reviewed by a neonatologist, who was blinded to the group assignments. Data analysis was conducted using appropriate statistical methods, ensuring adherence to ethical standards.
Detailed description
I.Project Summary In this randomized clinical study, who are hospitalize in the neonatal intensive care unit pediatric department of King Salman Armed Forces Hospital Northwestern Region KSA Neonates who require umbilical venous catheter (UVC) insertion during their NICU admission will be randomized to one of the 2 formulas 1) umbilicus to the nipple in cm minus 1 (UN - 1) or 2) and birth weight based formula (1.5×birth weight (Kg) + 5.6) for estimation of the pre-insertion UVC depth. UVC will be inserted under sterile condition as per our unit protocol. Then to determine the UVC tip position, anteroposterior and lateral a thoracoabdominal radiograph will be taken.
II.Introduction Umbilical vessel catheterization of newborns was used for more than 60 years (1,2).The ideal position of UVC tip to decrease complications is outside the heart at the junction of inferior vena cava and right atrium (3). UVC related complications are mainly due to catheter malposition as pericardial effusions , cardiac tamponade and cardiac thrombus have been reported with UVCs whose tips lay within the heart (4). There is no definite rule describe how far umbilical catheters should be inserted in the umbilical vein; different methods including the Dunn method, Shukla-Ferrara, modified Shukla-Ferrara and umbilicus to the nipple formulae are used (5). Selection of the most correct methods is very important in terms of decreasing th risk and frequency of complications (6,7). IN KFMC NICU and Alyamah NICU and Pediatric department of King Salman Armed Forces Hospital Northwestern Region KSA , the most commonly used method for estimation of UVC insertion length is the birth weight based formula (3× birth weight (Kg) +9)/2. A recent retrospective study reported that 57% accuracy rate with birth weight based formula(8). In our units no audit done for accuracy rate of UVC dependent on birth weight based formula endpoint
The endpoint measurement of UVC tip determined by anteroposterior x ray (12,13) to check where is the tipe of UVC located that is used in our unit
III.Project Objectives
Research Questions: Does the estimating insertion depth using umbilicus to the nipple in cm minus 1 (UN - 1) formula more accurate than a birth weight-derived formula resulted in more correctly placed umbilical venues catheters.
Primary objective: to compare accuracy rate between UVC insertion length estimated by using 1)umbilicus to the nipple distance in cm minus 1 (UN - 1) formula and 2) Shukla's exact birth weight based formula (3× birth weight (Kg) +9)/2to determine optimum UVC tip position compared against the standard accepted level UVC tip at the level of the diaphragm or the upper border of the 9th and the lower border of the 10th thoracic vertebrae (T9-T10) on the anteroposterior and lateral X-ray Secondary objective: to compare the accuracy rate of UVC tip position between two formulae depend on appropriation of baby to gestational age (AGA, SGA, LGA) AGA: appropriate for gestational age (i.e birth weight between 10th and 90th percentile for gestational age); SGA: Small for gestational age (i.e. birth weight <10th percentile for gestational age); LGA: large for gestational age (i.e. birth weight >90th percentile for gestational age)
IV.Literature Survey/Background Insertion of umbilical venous catheters in newborns admitted to hospital in neonatal intensive care units (NICU) who are preterm or have severe morbidity is a commonly used method for Venus access to maintain fluid support , parenteral nutrition ,administration of blood products, , administration of antibiotic , exchange transfusion and investigations, as well as providing emergency intravenous access (9). Ideally, umbilical venous catheters are placed under guidance of imaging methods. However, umbilical venous catheters are placed without any imaging method in emergency cases in NICUs. This leads to frequent occurrence of malposition of UVC (10,11). The commonly used formulas to estimate the depth of umbilical catheter include a birth weight based formula proposed by Shukla and Ferrara and Dunn's shoulder to umbilical length graph. In our units in the neonatal intensive care unit of KFMC / Al Yamamh Hospital KSA , the most commonly used method for estimation of UVC insertion length is the exact birth weight based formula (3× birth weight (Kg) +9)/2)(14). A recent retrospective study reported a distance from base of umbilicus to nipple distance (UN)-1 cm formula consider best and most accurate insertion depth of UVC with accuracy rate of 84% compared with 57% accuracy rate with birth weight based formula(8). In the literature, few studies have compared the two methods in determining how far umbilical catheters should be inserted in the umbilical vein
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 UVC insertion depth estimated using the Umbilicus to Nipple distance (UN) minus 1 | Active comparator | Other: UVC insertionNeonates who met the eligibility criteria were randomly assigned to one of two groups. Group 1 had their UVC insertion depth estimated using the Umbilicus to Nipple distance (UN) minus 1 cm formula (Gupta method), while Group 2 used the birth weight formula (3*wt +9)/2 (modified Shukla). Randomization was achieved using a computer-generated sequence, with allocation in blocks of four. The neonates were randomized in a 1:1 ratio. Initially, 184 infants were assessed for eligibility to participate in the study. Of these, 4 were excluded due to refusal to participate. The remaining 180 infants were randomly assigned to one of two intervention groups (the Gupta group or the modified Shukla group) in a 1:1 ratio. All infants in both groups received the allocated intervention, with no cases lost to follow-up or discontinuation of the intervention. |
| Group 2 UVC insertion used the birth weight formula (3*wt +9)/2 (modified Shukla) | Active comparator | Other: UVC insertionNeonates who met the eligibility criteria were randomly assigned to one of two groups. Group 1 had their UVC insertion depth estimated using the Umbilicus to Nipple distance (UN) minus 1 cm formula (Gupta method), while Group 2 used the birth weight formula (3*wt +9)/2 (modified Shukla). Randomization was achieved using a computer-generated sequence, with allocation in blocks of four. The neonates were randomized in a 1:1 ratio. Initially, 184 infants were assessed for eligibility to participate in the study. Of these, 4 were excluded due to refusal to participate. The remaining 180 infants were randomly assigned to one of two intervention groups (the Gupta group or the modified Shukla group) in a 1:1 ratio. All infants in both groups received the allocated intervention, with no cases lost to follow-up or discontinuation of the intervention. |
Who may qualify
- Ages
- Up to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All neonates who require UVC insertion as part of their intensive care during their NICU admission
Key exclusion criteria (2 listed)
- Any neonate where the UVC is medically contra-indicated like lower limb ischemia, omphalitis, umbilical bleeding, confirmed intra-vascular thrombosis or DIC.
- Neonates with hydrops fetalis, abdominal wall defects, congenital diaphragmatic hernia, major congenital heart disease, and declined to participate or insertion of UVC beyand one week .
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 insertionUVC insertion was performed under sterile conditions according to the unit protocol by a senior NICU physician. For preterm deliveries, written informed consent was obtained from a parent before enrollment in the study. In emergency cases, where the neonate required immediate UVC insertion upon admission to the NICU, a waiver of informed consent was applied. In such instances, parents were informed as soon as possible about their infant's participation in the study, provided with written information, and asked for their consent to include their infant's data in the analysis, with the option to give consent via telephone if they were unable to be present in person. After UVC insertion, anteroposterior and lateral thoracoabdominal radiographs were performed to verify the position of the UVC tip. | Other | Group 1 UVC insertion depth estimated using the Umbilicus to Nipple distance (UN) minus 1, Group 2 UVC insertion used the birth weight formula (3*wt +9)/2 (modified Shukla) |
Primary outcome
Proportion of correctly inserted UVC at optimum catheter tip position for each method
Time frame: Within 48 Hours
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 1 Jul 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVC insertion in people with Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurements, run by King Fahad Medical City at 1 site in Saudi Arabia.
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 2 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 1 Jul 2025. 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 Saudi Arabia. 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?
Proportion of correctly inserted UVC at optimum catheter tip position for each method (time frame: Within 48 Hours). 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 1 Jul 2025.