BreastfeedingNCT03655314
Using the Electronic Health Record to Guide Management of Newborn Weight Loss
A study testing NEWT in people with Breastfeeding and Breastfeeding, Exclusive, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 96 hoursHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breastfeeding, Exclusive, Morbidity;Perinatal
- What is being tested?
- NEWT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,682 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 96 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco Medical Center
San Francisco, California, 94122
About this study
Official title: Beginning With a Healthy Start: A Randomized Controlled Trial of Informatics-Enhanced Newborn Weight Management
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).
- Being tested
- NEWT, Usual care
- Keywords
- formula
- Medical subject headings
- Breast Feeding, Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEWTOther
Also called Newborn Weight Tool
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.
Usual careOther
The electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-96 hours
Secondary outcomes (8)
Proportion readmitted to the hospital
Readmission to the hospital after discharge from the birth hospitalization
Measured: 0-30 days
Length of hospital stay
Length of stay during the birth hospitalization
Measured: 0-96 hours
Proportion exclusively breastfed
Feeding only breast milk without any other fluid or food other than vitamins, minerals and medications
Measured: 0-96 hours
Proportion with donor milk use
Use of banked donor milk
Measured: 0-96 hours
Excess neonatal outpatient utilization
>3 outpatient visits in the first 30 days (newborns may have up to 3 preventive outpatient visits in the first 30 days)
Measured: 0-30 days
Ratio of indicated formula use to non-indicated formula use during the birth hospitalization
Ratio of formula used either for hypoglycemia or for weight loss >=75th centile to formula used for in the absence of these
Measured: 0-30 days
Non-preventive outpatient utilization
Number of non-preventive outpatient visits
Measured: 0-30 days
Outpatient utilization
Number of outpatient visits
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start20 Sep 2018
- Primary completion30 Nov 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,682 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Flaherman, MD, MPH, Principal investigator, Associate Professor of Pediatrics and Epidemiology and Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655314
- Sponsor's protocol ID
- 17-23249
- Status last verified
- Mar 2020
- First submitted
- 27 Aug 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35611641
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beginning With a Healthy Start: A Randomized Controlled Trial of Informatics-Enhanced Newborn Weight Management
- ClinicalTrials.gov ID
- NCT03655314
- Acronym / sponsor ID
- 17-23249
- Keywords
- formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,682 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newborn Weight Tool (NEWT) | Active comparator | Other: NEWTThe 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 |
| Usual care | Placebo comparator | Other: Usual careAs with usual care, the electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight |
Who may qualify
- Ages
- 6 to 96 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEWTAlso: Newborn Weight ToolThe 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 | Newborn Weight Tool (NEWT) |
| Usual careThe electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight. | Other | Usual care |
Primary outcome
Concordance with feeding recommendation during the birth hospitalization
Time frame: 0-96 hours
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.
8 secondary outcomes
Proportion readmitted to the hospital
Time frame: 0-30 days
Length of hospital stay
Time frame: 0-96 hours
Proportion exclusively breastfed
Time frame: 0-96 hours
Proportion with donor milk use
Time frame: 0-96 hours
Excess neonatal outpatient utilization
Time frame: 0-30 days
Ratio of indicated formula use to non-indicated formula use during the birth hospitalization
Time frame: 0-30 days
Non-preventive outpatient utilization
Time frame: 0-30 days
Outpatient utilization
Time frame: 0-30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 35611641Flaherman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Flaherman, MD, MPH principal investigator
Associate Professor of Pediatrics and Epidemiology and Biostatistics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEWT in people with Breastfeeding and Breastfeeding, Exclusive, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance with feeding recommendation during the birth hospitalization (time frame: 0-96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03655314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.