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NCT03655314
Using the Electronic Health Record to Guide Management of Newborn Weight Loss
NA trial testing NEWT in Breastfeeding in 2,682 participants. Completed in 30 December 2019.
30 November 2019
Quick facts
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 2,682 |
| Start date | 20 September 2018 |
| Primary completion | 30 November 2019 |
| Estimated completion | 30 December 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- NEWT
- Usual care
Conditions studied
- Breastfeeding — all drugs for Breastfeeding →
- Breastfeeding, Exclusive — all drugs for Breastfeeding, Exclusive →
- Morbidity;Perinatal — all drugs for Morbidity;Perinatal →
- Feeding, Bottle — all drugs for Feeding, Bottle →
Sponsor
University of California, San Francisco
Who can join
Adults 6 Hours to 96 Hours, any sex, with Breastfeeding or Breastfeeding, Exclusive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03655314
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of California, San Francisco trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03655314 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
- Last refreshed: 26 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03655314.
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