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

Study Overview
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Brief Summary
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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).

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

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

Intervention / Treatment
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* Other: NEWT
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Hours
Maximum Age: 96 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Newborn Weight Tool (NEWT)<br>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<br>* 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.<br>* Other names: Newborn Weight Tool;|
| Placebo Comparator: Usual care<br>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<br>* The electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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formula