Breastfeeding, Breastfeeding, Exclusive, Feeding, Bottle, Morbidity;Perinatal
Conditions
Keywords
formula
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).
Interventions
OTHERNEWT
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.
OTHERUsual care
The electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Hours to 96 Hours
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 0-96 hours | Length of stay during the birth hospitalization |
| Proportion exclusively breastfed | 0-96 hours | Feeding only breast milk without any other fluid or food other than vitamins, minerals and medications |
| Proportion with donor milk use | 0-96 hours | Use of banked donor milk |
| Proportion readmitted to the hospital | 0-30 days | Readmission to the hospital after discharge from the birth hospitalization |
| 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 |
| Non-preventive outpatient utilization | 0-30 days | Number of non-preventive outpatient visits |
| Outpatient utilization | 0-30 days | Number of outpatient visits |
| 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) |
Countries
United States
Outcome results
None listed