Umbilical Venous Catheter Insertion Depth in Neonates

Study Overview
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Brief Summary
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In this randomized clinical study, neonates who require umbilical venous catheter (UVC) insertion as part of their routine care at anytime during their NICU admission will be randomized to one of the 2 formulas for estimation of the pre-insertion UVC depth (umbilicus to the nipple in cm minus 1 (UN - 1) or birth weight based formula ([(3× birth weight (Kg) + 9)/2+1)]. UVC will be inserted under sterile condition as per unit protocol. To verify the UVC tip position, a thoracoabdominal radiograph will be taken. In addition, the investigators will do a ultrasound of the heart to assess the exact location of the catheter tips as soon as possible but within 6 hours of insertion.

Detailed Description
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Background: The ideal position of UVC) tip to minimize complications is just outside the heart at the junction of inferior vena cava and right atrium. UVC related complications are mainly due to catheter malposition. Accurate prediction of insertion length of UVC as well as confirmation of the position after insertion by radiograph or with ultrasound is very important to avoid complications. UVC malposition with subsequent re-positioning exposes these fragile infants to unnecessary handling, further radiologic exposure and increasing risk of infection. The commonly used formulas to estimate the depth of umbilical catheter include Dunn's shoulder to umbilical length graph and a birth weight based formula proposed by Shukla and Ferrara in 1986. In Calgary, the most commonly used method for estimation of UVC insertion length is the birth weight based formula (i.e. UVC insertion length = (3 x birth weight + 9)/2 +1). The success rate of achieving the optimum position of catheter tip using this formula ranges from 31-40%. A recent retrospective study reported the use of different surface markers for calculating UVC insertion depth. A distance from base of umbilicus to nipple distance (UN)-1 cm provided the best and most accurate insertion depth of UVC. This formula had accuracy rate of 84% compared with 57% accuracy rate with birth weight based formula. The objectives of our study are: To compare accuracy rate between UVC insertion length estimated by using two formula (i.e. umbilicus to the nipple distance in cm minus 1 (UN - 1) and Shukla's birth weight based formula ([(3× birth weight (Kg) + 9)/2+1)] in achieving optimum UVC tip position To compare the accuracy rate of UVC tip position between two methods based on growth status of neonates Methods: This is a randomized clinical study. All infants who require UVC insertion as part of their routine care at anytime during their hospital admission are eligible for the study. Infants with hydrops fetalis, abdominal wall defects, congenital diaphragmatic hernia and/or major structural heart disease will be excluded from the study. When a newborn baby needs UVC central line insertion, neonate will be randomized to one of the 2 formulas for estimation of the pre-insertion UVC depth. UVC will be inserted under sterile condition as per unit protocol. To verify the UVC tip position, a thoracoabdominal radiograph will be taken. In addition,the investigators will do a ultrasound of the the heart to assess the exact location of the catheter tips as soon as possible but within 6 hours of insertion.

Official Title
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Estimation of Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurement: A Randomized Trial

Conditions
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Central Venous Catheterization

Intervention / Treatment
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* Device: UVC
* Device: UVC
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All infants who require UVC insertion as part of their routine care at anytime during their NICU admission Exclusion Criteria: Infants with hydrops fetalis, infants with abdominal wall defects, congenital diaphragmatic hernia and major structural heart disease

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 2 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UVC and surface measurement formula<br>UVC insertion depth = Umbilicus to nipple distance minus 1cm | Device: UVC<br>* UVC insertion depth calculated by umbilicus to nipple distance-1<br>* Other names: UVC insertion using surface measurement;Device: Ultrasound<br> <br> * Other names: Ultrasound assessment of UVC;|
| Active Comparator: UVC and Birth weight based formula<br>UVC insertion depth=[(3× birth weight (Kg) + 9)/2+1)] cm | Device: UVC<br>* UVC insertion depth calculated by [(3× birth weight (Kg) + 9)/2+1)]<br>* Other names: UVC insertion using birth weight based calculation;Device: Ultrasound<br> <br> * Other names: Ultrasound assessment of UVC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of correctly inserted UVC at optimum catheter tip position |  | within 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of readjustment of UVC |  | within first 2 weeks | 
| Comparison of UVC tip position between two methods based on based growth status at birth (i.e.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 percetile for gestational age); LGA: large for gestational age (i.e.birth weight >90th percentile for gestational age) using Fentons growth chart for preterm infants and WHO growth chart for term infants | within 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter, Umbilical vein, Neonate