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

Beginning With a Healthy Start: A Randomized Controlled Trial of Informatics-Enhanced Newborn Weight Management

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 Overview

• Status: Completed
• Conditions: Breastfeeding; Breastfeeding, Exclusive; Feeding, Bottle; Morbidity;Perinatal
• Intervention / Treatment: Other: NEWT; Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 2682
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94122
      • University of California, San Francisco Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 hours to 4 days (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Newborn Weight Tool (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	Other: NEWT; 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.; Other Names: Newborn Weight Tool
PLACEBO_COMPARATOR: 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	Other: Usual care; The electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-96 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion readmitted to the hospital	Readmission to the hospital after discharge from the birth hospitalization	0-30 days
Length of hospital stay	Length of stay during the birth hospitalization	0-96 hours
Proportion exclusively breastfed	Feeding only breast milk without any other fluid or food other than vitamins, minerals and medications	0-96 hours
Proportion with donor milk use	Use of banked donor milk	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)	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	0-30 days
Non-preventive outpatient utilization	Number of non-preventive outpatient visits	0-30 days
Outpatient utilization	Number of outpatient visits	0-30 days

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Valerie Flaherman, MD, MPH, Associate Professor of Pediatrics and Epidemiology and Biostatistics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2018
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (ACTUAL): August 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: formula
• Other Study ID Numbers: 17-23249

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No