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

Not Applicable
Completed
Conditions
Breastfeeding, Exclusive
Breastfeeding
Feeding, Bottle
Morbidity;Perinatal
Interventions
Other: Usual care
Other: NEWT
Registration Number
NCT03655314
Lead Sponsor
University of California, San Francisco
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2682
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
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Exclusion Criteria
  • None
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Usual careUsual careAs with usual care, the electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight
Newborn Weight Tool (NEWT)NEWTThe 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
Primary Outcome Measures
NameTimeMethod
Concordance with feeding recommendation during the birth hospitalization0-96 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 Outcome Measures
NameTimeMethod
Outpatient utilization0-30 days

Number of outpatient visits

Proportion exclusively breastfed0-96 hours

Feeding only breast milk without any other fluid or food other than vitamins, minerals and medications

Excess neonatal outpatient utilization0-30 days

\>3 outpatient visits in the first 30 days (newborns may have up to 3 preventive outpatient visits in the first 30 days)

Non-preventive outpatient utilization0-30 days

Number of non-preventive outpatient visits

Proportion readmitted to the hospital0-30 days

Readmission to the hospital after discharge from the birth hospitalization

Length of hospital stay0-96 hours

Length of stay during the birth hospitalization

Proportion with donor milk use0-96 hours

Use of banked donor milk

Ratio of indicated formula use to non-indicated formula use during the birth hospitalization0-30 days

Ratio of formula used either for hypoglycemia or for weight loss \>=75th centile to formula used for in the absence of these

Trial Locations

Locations (1)

University of California, San Francisco Medical Center

🇺🇸

San Francisco, California, United States

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