Using the Electronic Health Record to Guide Management of Newborn Weight Loss

University of California San Francisco (UCSF)

Status: Completed

Conditions: Morbidity;Perinatal; Breastfeeding; Feeding, Bottle; Breastfeeding, Exclusive

Treatments: Other: NEWT; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03655314

17-23249

Details and patient eligibility

About

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).

Enrollment: 2,682 patients

Sex: All

Ages: 6 to 96 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,682 participants in 2 patient groups, including a placebo group

Newborn Weight Tool (NEWT)

Active Comparator group

Description:

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

Treatment:

Other: NEWT

Usual care

Placebo Comparator group

Description:

As with usual care, the electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight

Treatment:

Other: Usual care