Hyperbilirubinemia, NeonatalNCT01330667
Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
A study testing Nutramigen Infant Formula in people with Hyperbilirubinemia, Neonatal, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3 mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for Phototherapy (PT). Read more about this study
- Who is it for?
- Ages 36 to 96 hoursHealthy volunteers can take part
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- What is being tested?
- Nutramigen Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2016
- 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 36 to 96 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants ≥ 35 weeks
- Neonates 36-96 hours old
- Exclusively breastfeeding
- TSB 0.1-3 mg/dl below AAP-recommended PT threshold
- TSB < 6 hours ago
- Mothers English-speaking or Spanish-speaking
Who cannot join
- Infants who have already received formula
- Infants who have received or are receiving Level II or Level III
- Infants who have already lost ≥ 10% birth weight
- Infants with Glucose-6-phosphate dehydrogenase deficiency, positive direct antigen testing, cephalohematoma or other extensive bruising
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
The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3 mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is that limited, small amounts of formula administered without a bottle immediately following breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.
Read the detailed description
Inclusion criteria
- Healthy infants ≥ 35 weeks
- Neonates 36-96 hours old
- Exclusively breastfeeding
- TSB 0.1-3 mg/dl below AAP-recommended PT threshold
- TSB < 6 hours ago
- Mothers English-speaking or Spanish-speaking
Outcome Measures
- Primary outcome: Total Serum Bilirubin
- Secondary clinical outcomes: Phototherapy, hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy
- Conditions
- Hyperbilirubinemia, Neonatal
- Being tested
- Nutramigen Infant Formula
- Keywords
- Hyperbilirubinemia, Breastfeeding, Limited Formula
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutramigen Infant FormulaDietary supplement
Also called Nutramigen
Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines.
| Study group | Role | What they receive |
|---|---|---|
| Formula Supplementation | Experimental | Participants will supplement feedings with early limited formula following nursing. Receives: Dietary Supplement: Nutramigen Infant Formula |
| Control | No intervention | Participants will be instructed to continue exclusively breastfeeding with no formula supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TSB meeting or exceeding AAP-recommended phototherapy treatment threshold.
The investigators will compare measured TSB to AAP guideline recommendations for phototherapy treatment and confirming with Bili Tool, an automated program designed for this purpose.
Measured: Up to two weeks after birth
Secondary outcomes (1)
Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy
The investigators will ask mothers whether the infant received any breast milk in the last 24 hours. For infants whose mothers state they have received breast milk in the last 24 hours, the investigators will ask mothers whether the infant received anything other than breast milk in the last 24 hours. The investigators will ask mothers whether the infant received anything other than breast milk since the prior assessment. The investigators will query subjects using the Breastfeeding Self Efficacy Scale, short form, at enrollment, 1week and at 1 month.
Measured: Up to three months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startJul 2015
- Primary completionJul 2015 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: funding not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbilirubinemia, NeonatalStudies 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
- 0 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, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330667
- Sponsor's protocol ID
- ELF for Hyperbilirubinemia
- Status last verified
- Nov 2018
- First submitted
- 23 Feb 2011
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT01330667
- Acronym / sponsor ID
- ELF for Hyperbilirubinemia
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- Hyperbilirubinemia, Breastfeeding, Limited Formula
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 7 Apr 2011 (estimated)
- 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.
The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3 mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is that limited, small amounts of formula administered without a bottle immediately following breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.
Detailed description
Inclusion criteria
- Healthy infants ≥ 35 weeks
- Neonates 36-96 hours old
- Exclusively breastfeeding
- TSB 0.1-3 mg/dl below AAP-recommended PT threshold
- TSB < 6 hours ago
- Mothers English-speaking or Spanish-speaking
Outcome Measures
- Primary outcome: Total Serum Bilirubin
- Secondary clinical outcomes: Phototherapy, hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formula Supplementation | Experimental | Dietary Supplement: Nutramigen Infant FormulaParticipants will supplement feedings with early limited formula following nursing. |
| Control | No intervention | –Participants will be instructed to continue exclusively breastfeeding with no formula supplementation. |
Who may qualify
- Ages
- 36 to 96 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy infants ≥ 35 weeks
- Neonates 36-96 hours old
- Exclusively breastfeeding
- TSB 0.1-3 mg/dl below AAP-recommended PT threshold
- TSB < 6 hours ago
Key exclusion criteria (4 listed)
- Infants who have already received formula
- Infants who have received or are receiving Level II or Level III
- Infants who have already lost ≥ 10% birth weight
- Infants with Glucose-6-phosphate dehydrogenase deficiency, positive direct antigen testing, cephalohematoma or other extensive bruising
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 |
|---|---|---|
| Nutramigen Infant FormulaAlso: NutramigenInvestigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines. | Dietary supplement | Formula Supplementation |
Primary outcome
TSB meeting or exceeding AAP-recommended phototherapy treatment threshold.
Time frame: Up to two weeks after birth
The investigators will compare measured TSB to AAP guideline recommendations for phototherapy treatment and confirming with Bili Tool, an automated program designed for this purpose.
1 secondary outcome
Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy
Time frame: Up to three months after birth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
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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
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutramigen Infant Formula in people with Hyperbilirubinemia, Neonatal, 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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 15 Nov 2018. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
TSB meeting or exceeding AAP-recommended phototherapy treatment threshold. (time frame: Up to two weeks after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2018.