Implementation of a Transcutaneous Bilirubinometer

NCT01622699 | Completed Results

• 1 other identifier: TcB AmaliaCC
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

Neonatal jaundice, caused by hyperbilirubinemia, is frequently seen in healthy newborns. Assessment of the degree of jaundice is usually done visually,and if necessary serum bilirubin is investigated in a blood sample. The visual assessment is subjective and can alternatively be replaced by transcutaneous measurement.The transcutaneous bilirubinometer is a validated measurement-tool, which provides us with an estimated serum bilirubin-concentration. Little is known about the effect of the actual use of a bilirubinometer on the quality of care. Further evidence is needed to evaluate whether transcutaneous bilirubin measurements improve clinical outcome (use of blood tests, phototherapy and exchange transfusion), shorten length of stay and reduce costs. Therefore we aim to perform a Randomized controlled trial to evaluate the cost-effectiveness of implementing the use of a transcutaneous bilirubinometer in jaundiced neonates, a gestational age of 32 weeks. The assessment of jaundice by use of a transcutaneous bilirubinometer is compared to visual assessment of jaundice

Conditions

Neonatal Jaundice; Hyperbilirubinemia

Keywords

Jaundice; Neonatal Jaundice; Hyperbilirubinemia; Transcutaneous bilirubin measurement; Transcutaneous bilirubinometry; jaundice meter; Visual assessment of bilirubin; Newborn

Outcome Measures

Primary Outcomes (1)

• Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy).

  up to 1 year

Secondary Outcomes (3)

• Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit'

  up to 1 year

• Highest Measured Serum Bilirubin-value

  up to 1 year

• Number of Patients Having Kernicterus

  up to 1 year

Study Arms (2)

Transcutaneous bilirubin measurements

EXPERIMENTAL

In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer

Device: Transcutaneous Bilirubinometer

Visual assessment of neonatal jaundice

ACTIVE COMPARATOR

In this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician

Other: visual assessment of neonatal jaundice

Interventions

Transcutaneous Bilirubinometer DEVICE

If a baby is jaundiced, the ward-nurse will perform a transcutaneous bilirubin measurement. It takes about 5 seconds to perform the measurement at the forehead or sternum of the baby. The device is a validated measurement-tool, which provides us with an estimated serum bilirubin-concentration. This is not an invasive procedure: A light-reflection is used to measure transcutaneous bilirubin.

Also known as: JaundiceMeter-103®, Dräger

Transcutaneous bilirubin measurements

visual assessment of neonatal jaundice OTHER

To detect newborns with jaundice (who will possibly meet the criteria for phototherapy) there have been international guidelines formulated by the American Academy of Pediatrics. The standard of care at the neonatal- and maternity ward of our hospital to detect those newborns is visual assessment according to these guidelines.

Visual assessment of neonatal jaundice

Eligibility Criteria

• Age: 24 Hours - 8 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All newborns at the pediatric- and maternity-ward with visible jaundice.
• Gestational age of 32 weeks or more.
• Older than 24 hours.
• Younger than 8 days.

You may not qualify if:

• Neonatal jaundice within 24 hours or after 8 days
• Hemolysis present based on maternal history (for example irregular erythrocyte antibodies)
• Bilirubin encephalopathy
• Newborns during/after phototherapy
• Large congenital anomaly at forehead/sternum
• Serum bilirubin-value is already known before admission to the pediatric ward;those newborns are to be admitted because the serum bilirubin-level has reached the phototherapy or exchange transfusion limit.

Sponsors & Collaborators

• Princess Amalia Children's Clinic: lead

Study Sites (1)

Isala Klinieken, Amalia Childrens Clinic

Zwolle, Overijssel, 8025AB, Netherlands

Location

Related Publications (4)

• American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297.

  PMID: 15231951 BACKGROUND

• Dijk PH, de Vries TW, de Beer JJ; Dutch Pediatric Association. [Guideline 'Prevention, diagnosis and treatment of hyperbilirubinemia in the neonate with a gestational age of 35 or more weeks']. Ned Tijdschr Geneeskd. 2009;153:A93. Dutch.

  PMID: 19785881 BACKGROUND

• Szabo P, Wolf M, Bucher HU, Fauchere JC, Haensse D, Arlettaz R. Detection of hyperbilirubinaemia in jaundiced full-term neonates by eye or by bilirubinometer? Eur J Pediatr. 2004 Dec;163(12):722-7. doi: 10.1007/s00431-004-1533-7.

  PMID: 15365826 BACKGROUND

• van den Esker-Jonker B, den Boer L, Pepping RM, Bekhof J. Transcutaneous Bilirubinometry in Jaundiced Neonates: A Randomized Controlled Trial. Pediatrics. 2016 Dec;138(6):e20162414. doi: 10.1542/peds.2016-2414. Epub 2016 Nov 4.

  PMID: 27940715 DERIVED

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia; Jaundice

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr J Bekhof
• Organization: Isala

j.bekhof@isala.nl

0384247492

Study Officials

• Jolita Bekhof, MD

  Isala

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 19, 2012
• Study Start: October 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 2, 2020
• Results First Posted: January 2, 2020

Record last verified: 2019-12

Locations

NL (1)