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

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655314
• Other study ID #: 17-23249
• Status: Completed
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2682
• Est. completion date: December 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 96 Hours

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Breastfeeding, Exclusive
• Feeding, Bottle
• Morbidity;Perinatal

Intervention

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.
• Usual care
The electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight.

Locations

Country	Name	City	State
United States	University of California, San Francisco Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

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