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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2682 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-20

Study Completion Date

2019-12-30

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).

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Detailed Description

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Conditions

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Breastfeeding Breastfeeding, Exclusive Morbidity;Perinatal Feeding, Bottle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

NEWT

Intervention Type OTHER

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

As with usual care, the electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Usual care

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

Intervention Type OTHER

Other Intervention Names

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Newborn Weight Tool

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