Trials / Completed
CompletedNCT03655314
Using the Electronic Health Record to Guide Management of Newborn Weight Loss
Beginning With a Healthy Start: A Randomized Controlled Trial of Informatics-Enhanced Newborn Weight Management
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,682 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 6 Hours – 96 Hours
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | Usual care | The electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight. |
Timeline
- Start date
- 2018-09-20
- Primary completion
- 2019-11-30
- Completion
- 2019-12-30
- First posted
- 2018-08-31
- Last updated
- 2020-03-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03655314. Inclusion in this directory is not an endorsement.