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

NCT03655314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2682

Last updated 2020-03-26

No results posted yet for this study

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).

Conditions

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

Interventions

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

Usual care

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

Sponsors & Collaborators

Principal Investigators

  • Valerie Flaherman, MD, MPH · Associate Professor of Pediatrics and Epidemiology and Biostatistics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Hours
Max Age
96 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2019-11-30
Completion
2019-12-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03655314 on ClinicalTrials.gov