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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 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 622-participant average among 28 other Breastfeeding trials with a reported enrollment target (331% higher). The trial reports 1 study location across 1 state.
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).
Conditions Studied
Interventions
- OTHER Usual care
- OTHER NEWT
Study Locations (1)
California
- University of California, San Francisco Medical Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,682 participants |
| Start Date | 2018-09-20 |
| Est. Completion | 2019-12-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03655314
The ClinicalTrials.gov registry entry for NCT03655314 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,682 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 622-participant average among 28 other Breastfeeding trials with a reported enrollment target (331% higher). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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