Clinical trial NCT03655314: Using the Electronic Health Record to Guide Management of Newborn Weight Loss
Official title: Beginning With a Healthy Start: A Randomized Controlled Trial of Informatics-Enhanced Newborn Weight Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Breastfeeding, Exclusive
Morbidity;Perinatal
Feeding, Bottle
Keywords: formula
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 2682
Sex: ALL
Minimum age (years): 6
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Concordance with feeding recommendation during the birth hospitalization
timeFrame: 0-96 hours
Secondary outcomes:
measure: Proportion readmitted to the hospital
timeFrame: 0-30 days
measure: Length of hospital stay
timeFrame: 0-96 hours
measure: Proportion exclusively breastfed
timeFrame: 0-96 hours
measure: Proportion with donor milk use
timeFrame: 0-96 hours
measure: Excess neonatal outpatient utilization
timeFrame: 0-30 days
measure: Ratio of indicated formula use to non-indicated formula use during the birth hospitalization
timeFrame: 0-30 days
measure: Non-preventive outpatient utilization
timeFrame: 0-30 days
measure: Outpatient utilization
timeFrame: 0-30 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
Study officials:
affiliation: Associate Professor of Pediatrics and Epidemiology and Biostatistics
name: Valerie Flaherman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flaherman VJ, Robinson A, Creasman J, McCulloch CE, Paul IM, Pletcher MJ. Clinical Decision Support for Newborn Weight Loss: A Randomized Controlled Trial. Hosp Pediatr. 2022 Jun 1;12(6):e180-e184. doi: 10.1542/hpeds.2021-006470.