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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,682
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.
The electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight.
University of California, San Francisco Medical Center
San Francisco, California, United States
Concordance with feeding recommendation during the birth hospitalization
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.
Time frame: 0-96 hours
Proportion readmitted to the hospital
Readmission to the hospital after discharge from the birth hospitalization
Time frame: 0-30 days
Length of hospital stay
Length of stay during the birth hospitalization
Time frame: 0-96 hours
Proportion exclusively breastfed
Feeding only breast milk without any other fluid or food other than vitamins, minerals and medications
Time frame: 0-96 hours
Proportion with donor milk use
Use of banked donor milk
Time frame: 0-96 hours
Excess neonatal outpatient utilization
\>3 outpatient visits in the first 30 days (newborns may have up to 3 preventive outpatient visits in the first 30 days)
Time frame: 0-30 days
Ratio of indicated formula use to non-indicated formula use during the birth hospitalization
Ratio of formula used either for hypoglycemia or for weight loss \>=75th centile to formula used for in the absence of these
Time frame: 0-30 days
Non-preventive outpatient utilization
Number of non-preventive outpatient visits
Time frame: 0-30 days
Outpatient utilization
Number of outpatient visits
Time frame: 0-30 days
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