NCT00801619

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

3.1 years

First QC Date

December 2, 2008

Last Update Submit

March 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adherence to clinical guidelines

    Adeherence to AAP clinical guidelines in treating neonatal hyperbilirubinemia

    Initial Newborn Inpatient Stay, which on average is 2-3 days in length

Study Arms (2)

Intervention

Receive decision support when reviewing bilirubin results in the clinical information systems/electronic health record

Control

No decision support

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Infants less than 35 weeks gestation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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: 15231951BACKGROUND

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John Patrick T Co, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

November 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations