Clinical Trials Directory

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

TypeNameDescription
OTHERNEWTThe 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.
OTHERUsual careThe 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.