NewbornsNCT04492579
Newborns Supplemented With Gentle-UHT Donor Milk
A study testing Gentle-UHT donor human milk supplementation in people with Newborns and Breast Milk Expression, run by LactaLogics, Inc at 1 site in United States.
Trial summary
This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued breastfeeding through the infant's first week of life. Read more about this study
- Who is it for?
- Ages Up to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Newborns, Breast Milk Expression
- What is being tested?
- Gentle-UHT donor human milk supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2018to 17 Jan 2020
- 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 Up to 4 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age >36 weeks
- Exclusively fed human milk
- Age <96 hours (4 days)
Who cannot join
- Previous admittance to the neonatal intensive care unit
- Supplementation of any formula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neonates Supplemented With Gentle-UHT Donor Human Milk in the First Week of Life
This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued breastfeeding through the infant's first week of life. The investigators aim to determine the safety of GHM, and if GHM provided to breastfeeding mothers of outpatient babies with early weight loss will ensure babies adequately gain weight according to age-matched controls.
- Conditions
- Newborns, Breast Milk Expression
- Being tested
- Gentle-UHT donor human milk supplementation
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle-UHT donor human milk supplementationOther
Providers referred mothers with newborns that fit the following criteria: exhibited insufficient milk supply, an infant with early weight loss born >36 weeks gestation. Mother was given Gentle-UHT donor milk for supplementation, in addition to mother's own milk for the first week of the infant's life after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Supplementation of Gentle-UHT donor milk | Experimental | Supplementation of Gentle-UHT donor milk in addition to mother's own milk, as recommended by the health care providers. Receives: Other: Gentle-UHT donor human milk supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Average weights compared to WHO data
Measured: 8-9 days of life
Secondary outcomes (1)
Exclusive human milk diet
Rates of infants still on an exclusive human milk diet
Measured: 8-9 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start3 Aug 2018
- Primary completion31 Jan 2019
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornsStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- LactaLogics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Renown Regional Medical Center
- Responsible party
- Sponsor
- Investigators
- Rebecca Perry, MD, Principal investigator, Renown Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492579
- Sponsor's protocol ID
- 5642622173
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonates Supplemented With Gentle-UHT Donor Human Milk in the First Week of Life
- ClinicalTrials.gov ID
- NCT04492579
- Acronym / sponsor ID
- 5642622173
- Conditions
- Newborns, Breast Milk Expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- LactaLogics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Renown Regional Medical Center
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 30 Jul 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.
This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued breastfeeding through the infant's first week of life. The investigators aim to determine the safety of GHM, and if GHM provided to breastfeeding mothers of outpatient babies with early weight loss will ensure babies adequately gain weight according to age-matched controls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supplementation of Gentle-UHT donor milk | Experimental | Other: Gentle-UHT donor human milk supplementationSupplementation of Gentle-UHT donor milk in addition to mother's own milk, as recommended by the health care providers. |
Who may qualify
- Ages
- Up to 4 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age >36 weeks
- Exclusively fed human milk
- Age <96 hours (4 days)
Key exclusion criteria (2 listed)
- Previous admittance to the neonatal intensive care unit
- Supplementation of any formula
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 |
|---|---|---|
| Gentle-UHT donor human milk supplementationProviders referred mothers with newborns that fit the following criteria: exhibited insufficient milk supply, an infant with early weight loss born >36 weeks gestation. Mother was given Gentle-UHT donor milk for supplementation, in addition to mother's own milk for the first week of the infant's life after hospital discharge. | Other | Supplementation of Gentle-UHT donor milk |
Primary outcome
Weight gain
Time frame: 8-9 days of life
Average weights compared to WHO data
1 secondary outcome
Exclusive human milk diet
Time frame: 8-9 days of life
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 30 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Rebecca Perry, MD principal investigator
Renown Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle-UHT donor human milk supplementation in people with Newborns and Breast Milk Expression, run by LactaLogics, Inc 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 2 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 30 Jul 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. 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?
Weight gain (time frame: 8-9 days of life). 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 30 Jul 2020.