This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Bilicurves: Using Information Technology to Improve the Management of Neonatal Hyperbilirubinemia

This study has been completed.
Information provided by (Responsible Party):
John Patrick Co, Massachusetts General Hospital Identifier:
First received: December 2, 2008
Last updated: March 14, 2016
Last verified: March 2016
We will use information technology to integrate the 2004 American Academy of Pediatrics guidelines for management of neonatal hyperbilirubinemia with laboratory reporting of newborn bilirubin test results to improve physician adherence to the guidelines and quality of care.

Neonatal Hyperbilirubinemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bilicurves: Using Information Technology to Integrate Clinical Practice Guidelines Into the Management of Neonatal Hyperbilirubinemia

Resource links provided by NLM:

Further study details as provided by John Patrick Co, Massachusetts General Hospital:

Primary Outcome Measures:
  • Adherence to clinical guidelines [ Time Frame: Initial Newborn Inpatient Stay, which on average is 2-3 days in length ]
    Adeherence to AAP clinical guidelines in treating neonatal hyperbilirubinemia

Enrollment: 273
Study Start Date: November 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Receive decision support when reviewing bilirubin results in the clinical information systems/electronic health record
No decision support

Detailed Description:

In 2004, the American Academy of Pediatrics disseminated clinical practice guidelines for the management of neonatal hyperbilirubinemia. Using the infant's age in hours, serum bilirubin levels are applied to hour-specific nomograms to assess risk of developing significant hyperbilirubinemia as well as the necessity for treatment. Prior guidelines did not include nomograms for either. A systems approach to managing neonatal hyperbilirubinemia, including use of the nomograms, has been shown to improve outcomes and patient safety.

Despite the existence of these guidelines, decision support does not exist within MGH clinical information systems for managing neonatal hyperbilirubinemia. We propose to create BiliCurves, an application that integrates perinatal information from the obstetrical health record with that of the newborn's, providing seamless reporting of neonatal bilirubin results in the context of the practice guidelines and relevant obstetrical data. BiliCurves will graphically superimpose bilirubin results onto hour-specific guideline nomograms that providers can view when viewing bilirubin results. We propose to randomize BiliCurves access to pediatric providers, and study its effects on management of hyperbilirubinemia both during birth hospitalization as well as in the outpatient setting after discharge. We hypothesize infants treated by physicians with BiliCurves access will receive birth hospitalization phototherapy at a higher rate and readmission for hyperbilirubinemia at a lower rate than that of the control group. We also hypothesize that physicians with BiliCurves access will report greater ease and confidence in nomogram use and providing evidence-based care as BiliCurves obviates the provider having to have access to paper based versions of the nomogram (usual care) as well decreases potential errors in plotting test results on the nomograms.


Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Providers who care for infants in the newborn nursery at MGH will be study eligible. All newborns 35 weeks or more weeks of gestation will be study eligible.

Inclusion Criteria:

  • Providers who care for infants in the newborn nursery.
  • All newborns in the newborn nursery that are 35 weeks or more weeks of gestation will be study eligible.

Exclusion Criteria:

  • Infants less than 35 weeks gestation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00801619

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: John Patrick T Co, MD, MPH Massachusetts General Hospital
  More Information

Responsible Party: John Patrick Co, Principal Investigator, Massachusetts General Hospital Identifier: NCT00801619     History of Changes
Other Study ID Numbers: 2006P001624
Study First Received: December 2, 2008
Last Updated: March 14, 2016

Additional relevant MeSH terms:
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Pathologic Processes processed this record on June 22, 2017