Using the Electronic Health Record to Guide Management of Newborn Weight Loss
- Conditions
- Breastfeeding, ExclusiveBreastfeedingFeeding, BottleMorbidity;Perinatal
- Interventions
- Other: Usual careOther: NEWT
- Registration Number
- NCT03655314
- Lead Sponsor
- University of California, San Francisco
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2682
- 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
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care 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 Newborn Weight Tool (NEWT) 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method Outpatient utilization 0-30 days Number of outpatient visits
Proportion exclusively breastfed 0-96 hours Feeding only breast milk without any other fluid or food other than vitamins, minerals and medications
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)
Non-preventive outpatient utilization 0-30 days Number of non-preventive outpatient visits
Proportion readmitted to the hospital 0-30 days Readmission to the hospital after discharge from the birth hospitalization
Length of hospital stay 0-96 hours Length of stay during the birth hospitalization
Proportion with donor milk use 0-96 hours Use of banked donor milk
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
Trial Locations
- Locations (1)
University of California, San Francisco Medical Center
🇺🇸San Francisco, California, United States