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NCT03655314 · ClinicalTrials.gov registry record · NA

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

A NA study of Breastfeeding and Breastfeeding, Exclusive, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
2,682
Enrollment target
1
Study location

NCT03655314: Completed NA study of Breastfeeding and Breastfeeding, Exclusive, sponsored by University of California, San Francisco.

NCT03655314 is a NA study of Breastfeeding and Breastfeeding, Exclusive that has completed, run by University of California, San Francisco. The registered enrollment target is 2,682 participants, above the 523-participant average among 36 other Breastfeeding trials with a reported enrollment target (413% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03655314, a NA study of Breastfeeding and Breastfeeding, Exclusive, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
2,682 participants
Enrollment target
1
Study location

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).

Primary Outcome

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.

Interventions

  • OTHER Usual care
  • OTHER NEWT

Study Locations (1)

California

  • University of California, San Francisco Medical Center - San Francisco

Trial Details

FieldValue
Enrollment Target 2,682 participants
Start Date 2018-09-20
Est. Completion 2019-12-30
Phase NA

What the finished NCT03655314 record still lists

NCT03655314 is an interventional study that assigns participants to a tested intervention. Its 2,682 participants enrollment target places it among the larger protocols in the corpus, above the 523-participant average among 36 other Breastfeeding trials with a reported enrollment target (413% higher).

The record links to 4 conditions, with Breastfeeding appearing as the primary indexed condition, and to 2 interventions - of which Usual care is the first listed.

NCT03655314 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT03655314 about?

NCT03655314 is a clinical study titled "Using the Electronic Health Record to Guide Management of Newborn Weight Loss". 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...

What is the current status of trial NCT03655314?

This trial is currently completed. It is a NA study. The enrollment target is 2,682 participants. The study started on 2018-09-20. Estimated completion is 2019-12-30.

What conditions does trial NCT03655314 study?

This clinical trial studies the following conditions: Breastfeeding, Breastfeeding, Exclusive, Morbidity;Perinatal, Feeding, Bottle.

What interventions are being tested in trial NCT03655314?

The interventions under investigation include: Usual care (OTHER), NEWT (OTHER).

Who is sponsoring clinical trial NCT03655314?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03655314 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breastfeeding

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03655314's enrollment target sits among peer trials

2,682 3rd of 36 higher than 34 of 36 other Breastfeeding trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breastfeeding trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03655314, the US trial registry maintained by the National Library of Medicine. NCT03655314 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.