Using the Electronic Health Record to Guide Management of Newborn Weight Loss

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT03655314
Collaborator
(none)
2,682
1
2
15.3
175.2

Study Details

Study Description

Brief Summary

Weight loss is normal for healthy newborns in the first few days, especially for those exclusively breastfed, who may have low enteral intake for several days. Although most newborns tolerate this early period of weight loss well, those with pronounced weight loss become at increased risk of feeding problems and hyperbilirubinemia, which are the two most common causes of neonatal readmission. To facilitate the assessment of risk for an individual newborn, the Newborn Weight Tool (NEWT) has been developed to categorize each infant's weight loss according to population norms, so that formula can be administered when weight loss is pronounced and avoided when weight loss is normal. The Healthy Start study will be a randomized, controlled trial testing whether displaying NEWT to clinicians providing newborn care can improve neonatal health outcomes including formula use, weight loss and readmission. Newborns will be randomly assigned either to display weight with NEWT weight categorization to their providers in the electronic health record (EHR) or to usual care (weight displayed without NEWT categorization).

Condition or Disease Intervention/Treatment Phase
  • Other: NEWT
  • Other: Usual care
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2682 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Beginning With a Healthy Start: A Randomized Controlled Trial of Informatics-Enhanced Newborn Weight Management
Actual Study Start Date :
Sep 20, 2018
Actual Primary Completion Date :
Nov 30, 2019
Actual Study Completion Date :
Dec 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Newborn Weight Tool (NEWT)

The electronic medical record will display the Newborn Weight Tool along with a banner flagging newborn weight loss greater than or equal to the 75th centile of birth weight

Other: NEWT
The Newborn Weight Tool (NEWT) is publicly available at www.newbornweight.org. For this intervention, NEWT will be embedded into the electronic medical record along with a flag for weight loss greater than or equal to the 75th centile of birth weight.
Other Names:
  • Newborn Weight Tool
  • Placebo Comparator: Usual care

    As with usual care, the electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight

    Other: Usual care
    The electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight.

    Outcome Measures

    Primary Outcome Measures

    1. Concordance with feeding recommendation during the birth hospitalization [0-96 hours]

      Feeding is defined as concordant with feeding recommendation if any of the following occur: 1) for newborns who do not have documented weight loss >=75th NEWT centile, formula is not used; 2) for newborns with only one weight documented that is more pronounced than the 75th centile, no formula is used prior to the weight documented at more pronounced than the 75th centile; 3) for newborns who have two weights documented more pronounced than the 75th centile, formula is used.

    Secondary Outcome Measures

    1. Proportion readmitted to the hospital [0-30 days]

      Readmission to the hospital after discharge from the birth hospitalization

    2. Length of hospital stay [0-96 hours]

      Length of stay during the birth hospitalization

    3. Proportion exclusively breastfed [0-96 hours]

      Feeding only breast milk without any other fluid or food other than vitamins, minerals and medications

    4. Proportion with donor milk use [0-96 hours]

      Use of banked donor milk

    5. Excess neonatal outpatient utilization [0-30 days]

      >3 outpatient visits in the first 30 days (newborns may have up to 3 preventive outpatient visits in the first 30 days)

    6. Ratio of indicated formula use to non-indicated formula use during the birth hospitalization [0-30 days]

      Ratio of formula used either for hypoglycemia or for weight loss >=75th centile to formula used for in the absence of these

    7. Non-preventive outpatient utilization [0-30 days]

      Number of non-preventive outpatient visits

    8. Outpatient utilization [0-30 days]

      Number of outpatient visits

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Hours to 96 Hours
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Assignment to a bed assignment on the well newborn service at the time of the first weight measured subsequent to birth weight and at >6 hours and <=96 hours of age
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco Medical Center San Francisco California United States 94122

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Valerie Flaherman, MD, MPH, Associate Professor of Pediatrics and Epidemiology and Biostatistics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT03655314
    Other Study ID Numbers:
    • 17-23249
    First Posted:
    Aug 31, 2018
    Last Update Posted:
    Mar 26, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of California, San Francisco

    Study Results

    No Results Posted as of Mar 26, 2020