Infant, Newborn, DiseasePhase 4NCT04259008
Safety of Manganese Restriction in Neonatal Parenteral Nutrition
A Phase 4 study testing Manganese omission and 5 mCg/kg/day manganese from "Multitrace-4 Neonatal." in people with Infant, Newborn, Disease, run by Sharp HealthCare at 1 site in United States.
Trial summary
Participants will be <= 32 weeks gestational age (GA) neonates randomized to parenteral nutrition (PN) prepared with standard dose trace elements or to PN prepared with standard trace elements minus manganese. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Infant, Newborn, Disease
- What is being tested?
- Manganese omission and 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2020to 22 Jul 2021
- Phase
- Phase 4
- 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 Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn admissions to the SHARP Mary Birch Hospital for Women and Newborns neonatal intensive care unit.
- Less than or equal to 32+6 weeks gestational age.
- Initiated on parenteral nutrition as decided by their attending neonatologist.
Who cannot join
- Continuous exposure to routine care PN containing standard trace element for ≥ 4 hours.
- Congenital liver disease.
- Moribund status or imminent death.
- Any condition that in the judgment of the investigator or attending physician provider precludes participation because it could affect subject safety.
- Lack or refusal of informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
About this study
Participants will be <= 32 weeks gestational age (GA) neonates randomized to parenteral nutrition (PN) prepared with standard dose trace elements or to PN prepared with standard trace elements minus manganese.
Read the detailed description
Very preterm neonates <= 32+6 weeks GA receiving PN will be randomized to receive their PN prepared with standard trace elements containing 5 mcg/kg/day of manganese, or to PN prepared with no added manganese. Randomization assignment will be double masked. All participants will have whole blood manganese measurements at baseline, at 2 weeks of postnatal age, and at 8 weeks postnatal age. Because manganese is present as a contaminant in many of the ingredients used to prepare neonatal PN, this study hypothesizes that neonates randomized to no added manganese in their PN will maintain whole blood manganese concentrations above the lower limit of normal.
- Conditions
- Infant, Newborn, Disease
- Being tested
- Manganese omission, 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
- Keywords
- manganese, parenteral nutrition, neonate, preterm, safety
- Medical subject headings
- Disease, Hyperphagia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manganese omissionOther
Participants randomized to the experimental intervention arm will not receive added manganese in their parenteral nutrition.
5 mCg/kg/day manganese from "Multitrace-4 Neonatal."Other
5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
| Study group | Role | What they receive |
|---|---|---|
| Standard neonatal trace elements | Active comparator | Parenteral nutrition containing 5 mCg/kg/day manganese from "Multitrace-4 Neonatal." Receives: Other: 5 mCg/kg/day manganese from "Multitrace-4 Neonatal." |
| Manganese-free neonatal trace elements | Experimental | Parenteral nutrition containing the same trace element doses as "Multitrace-4 Neonatal" minus manganese. Receives: Other: Manganese omission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole Blood Manganese
concentration of manganese in blood
Measured: Baseline
Whole Blood Manganese
concentration of manganese in blood
Measured: 2 weeks of age
Whole Blood Manganese
concentration of manganese in blood
Measured: 8 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start11 Jun 2020
- Primary completion22 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Newborn, DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to standard trace element dose in parenteral nutrition vs. omission of manganese.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Jason Sauberan, PharmD, Sharp HealthCare
- Investigators
- Jason B Sauberan, PharmD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259008
- Sponsor's protocol ID
- 2001902
- Status last verified
- Aug 2021
- First submitted
- 5 Feb 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Manganese Restriction in Neonatal Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT04259008
- Acronym / sponsor ID
- 2001902
- Conditions
- Infant, Newborn, Disease
- Keywords
- manganese, parenteral nutrition, neonate, preterm, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 6 Feb 2020 (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.
Participants will be <= 32 weeks gestational age (GA) neonates randomized to parenteral nutrition (PN) prepared with standard dose trace elements or to PN prepared with standard trace elements minus manganese.
Detailed description
Very preterm neonates <= 32+6 weeks GA receiving PN will be randomized to receive their PN prepared with standard trace elements containing 5 mcg/kg/day of manganese, or to PN prepared with no added manganese. Randomization assignment will be double masked. All participants will have whole blood manganese measurements at baseline, at 2 weeks of postnatal age, and at 8 weeks postnatal age. Because manganese is present as a contaminant in many of the ingredients used to prepare neonatal PN, this study hypothesizes that neonates randomized to no added manganese in their PN will maintain whole blood manganese concentrations above the lower limit of normal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants randomized to standard trace element dose in parenteral nutrition vs. omission of manganese.
| Arm | Type | Receives |
|---|---|---|
| Standard neonatal trace elements | Active comparator | Other: 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."Parenteral nutrition containing 5 mCg/kg/day manganese from "Multitrace-4 Neonatal." |
| Manganese-free neonatal trace elements | Experimental | Other: Manganese omissionParenteral nutrition containing the same trace element doses as "Multitrace-4 Neonatal" minus manganese. |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Inborn admissions to the SHARP Mary Birch Hospital for Women and Newborns neonatal intensive care unit.
- Less than or equal to 32+6 weeks gestational age.
- Initiated on parenteral nutrition as decided by their attending neonatologist.
Key exclusion criteria (5 listed)
- Continuous exposure to routine care PN containing standard trace element for ≥ 4 hours.
- Congenital liver disease.
- Moribund status or imminent death.
- Any condition that in the judgment of the investigator or attending physician provider precludes participation because it could affect subject safety.
- Lack or refusal of informed consent
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 |
|---|---|---|
| Manganese omissionParticipants randomized to the experimental intervention arm will not receive added manganese in their parenteral nutrition. | Other | Manganese-free neonatal trace elements |
| 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."5 mCg/kg/day manganese from "Multitrace-4 Neonatal." | Other | Standard neonatal trace elements |
Primary outcome
Whole Blood Manganese
Time frame: Baseline
concentration of manganese in blood
Whole Blood Manganese
Time frame: 2 weeks of age
concentration of manganese in blood
Whole Blood Manganese
Time frame: 8 weeks of age
concentration of manganese in blood
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 25 Aug 2021.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Infant, Newborn, Disease
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Jason B Sauberan, PharmD principal investigator
Sharp HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Manganese omission and 5 mCg/kg/day manganese from "Multitrace-4 Neonatal." in people with Infant, Newborn, Disease, run by Sharp HealthCare 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 3 inclusion and 5 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 25 Aug 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Whole Blood Manganese (time frame: Baseline). The study lists 3 primary outcomes in all. 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 25 Aug 2021.