NCT03655314

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,682

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

August 27, 2018

Last Update Submit

March 24, 2020

Conditions

BreastfeedingBreastfeeding, ExclusiveMorbidity;PerinatalFeeding, Bottle

Keywords

formula

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Proportion readmitted to the hospital

    0-30 days

  • Length of hospital stay

    0-96 hours

  • Proportion exclusively breastfed

    0-96 hours

  • Proportion with donor milk use

    0-96 hours

  • Excess neonatal outpatient utilization

    0-30 days

  • +3 more secondary outcomes

Study Arms (2)

Newborn Weight Tool (NEWT)

ACTIVE COMPARATOR

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

Usual care

PLACEBO COMPARATOR

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

Interventions

NEWTOTHER

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.

Also known as: Newborn Weight Tool
Newborn Weight Tool (NEWT)
Usual careOTHER

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

Usual care

Eligibility Criteria

Age6 Hours - 96 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco Medical Center

San Francisco, California, 94122, United States

Location

Related Publications (1)

  • Flaherman VJ, Robinson A, Creasman J, McCulloch CE, Paul IM, Pletcher MJ. Clinical Decision Support for Newborn Weight Loss: A Randomized Controlled Trial. Hosp Pediatr. 2022 Jun 1;12(6):e180-e184. doi: 10.1542/hpeds.2021-006470.

    PMID: 35611641DERIVED

MeSH Terms

Conditions

Breast FeedingBottle Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Valerie Flaherman, MD, MPH

    Associate Professor of Pediatrics and Epidemiology and Biostatistics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 31, 2018

Study Start

September 20, 2018

Primary Completion

November 30, 2019

Study Completion

December 30, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

US(1)