Breast Milk CollectionLIMITNCT03573531
Investigating Lipid Peroxidation Products in Donor Human Milk
An observational study of Breast Milk Collection, run by Bournemouth University at 3 sites in United Kingdom.
Trial summary
This study will quantify lipid peroxidation products (malondialdehyde, 4 hydroxy-2-nonenal, hexanal, and 8-iso-PGF2α), fatty acid content, and antioxidant capacity in donor human milk sampled from two neonatal units in the UK. Comparison will be made to preterm transitional/mature milk and term mature milk. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Collection
- What is being tested?
- Laboratory analysis
- How many people
- 40 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 8 Nov 2018to 1 Apr 2019
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Donor human milk is donated by mothers, having a stable milk supply, to the respective milk bank from which it is requested from the neonatal units, where it is sampled. Preterm mothers will be selected from a neonatal unit in the U.K. Term mothers will be selected from the community form baby cafes and similar in the Bournemouth area.
Who may be able to join
- Donor human milk that was intended to feed an infant at a neonatal unit in the U.K will be used for this study. Donor human milk needs to be routinely discarded 24 hours after defrosting on the unit, at that point it will be used as sample for this study.
- Preterm transitional/mature breast milk will be sampled from healthy, asymptomatic mothers of a preterm baby (born < 37 weeks gestational age) as soon as a stable milk supply is established. Samples will only be obtained if there is a surplus to the babies' need.
- Term mature breast milk will be sampled from healthy, asymptomatic mothers in the community. Samples will only be obtained if there is a surplus to the babies' need.
Who cannot join
- Donor human milk that cannot be stored on ice or in the fridge within 2 hours and cannot be frozen at -80°C within 5 hours
- For preterm and term breast milk:
- Women < 18 years Women who are not able to access the study information in English Smoking women Women with mastitis Women who delivered after clinical chorioamnionitis, or other sepsis
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Bournemouth University
Bournemouth, BH13LT
St George's Hospitals NHS Foundation Trust
London, SW170QT
Poole Hospital NHS Foundation Trust
Poole, BH152JB
About this study
Official title: Investigating Lipid Peroxidation Products in Donor Human Milk- a Two-Centre Pilot Study
This study will quantify lipid peroxidation products (malondialdehyde, 4 hydroxy-2-nonenal, hexanal, and 8-iso-PGF2α), fatty acid content, and antioxidant capacity in donor human milk sampled from two neonatal units in the UK. Comparison will be made to preterm transitional/mature milk and term mature milk.
Read the detailed description
The investigators have recently identified that current human milk banking practices in the United Kingdom may have the potential to increase levels of lipid peroxidation products in donor human milk. It is therefore important to quantify the extent of this increase. This project aims to quantify for the first time the levels of lipid peroxidation products in donor human milk that is provided to infants on the neonatal unit.
Donor human milk samples will be collected from two neonatal units in the United Kingdom, served by different human milk banks. Fresh mature term breast milk, collected from healthy mothers in the community, and preterm transitional/mature breast milk, collected from healthy mothers at a neonatal unit, will be used for comparison. For each group, 10 x 5 mL samples will be analysed for the lipid peroxidation products, malondialdehyde, 4 hydroxy-2-nonenal, hexanal, and 8-iso-PGF2α. The fatty acid content and total antioxidant capacity will also be measured. All analysis will be undertaken at Bournemouth University.
- Conditions
- Breast Milk Collection
- Being tested
- Laboratory analysis
- Keywords
- donor human milk, lipid peroxidation, neonate, omega-3 fatty acids, omega-6 fatty acids, preterm infants, malondialdehyde
- 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.
Laboratory analysisOther
Analysis of lipid peroxidation markers (malondialdehyde, 4 hydroxy-2-nonenal, hexanal, and 8-iso-PGF2α) Analysis of fatty acid content Analysis of total antioxidant capacity
| Study group | Role | What they receive |
|---|---|---|
| Donor Human Milk | Donor Human Milk (processed by a human milk bank) Sampled at two different neonatal units in the United Kingdom Collection of 5 ml of otherwise routinely discarded donor human milk Receives: Other: Laboratory analysis | |
| Preterm Milk | Preterm transitional or mature breast milk Sampled from healthy mothers of preterm babies (born , 37 weeks gestational age) at a neonatal unit in the United Kingdom Collection of 5 ml at a time point of routine expression Receives: Other: Laboratory analysis | |
| Term Milk | Term mature breast milk Sampled from healthy mothers of term babies in the community (e.g. Baby Cafes). Collection of 5 ml expressed for this study Receives: Other: Laboratory analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid peroxidation markers
Analysis of malondialdehyde (TBARS, colourimetric), 4-hydroxy-2-nonenal (ELISA), hexanal (gas chromatography), and 8-iso-PGF2α (ELISA)
Measured: 2 weeks
Secondary outcomes (2)
Fatty acid content
Analysis of fatty acid content (gas chromatography)
Measured: 1 week
Antioxidant capacity
Analysis of antioxidant capacity (colourimetric)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start8 Nov 2018
- Primary completion13 Feb 2019
- Study completion1 Apr 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 Breast Milk CollectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabell Nessel, Principal investigator, Bournemouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573531
- Sponsor's protocol ID
- 1718/IRASIN/1
- Other IDs
- 221198
- Acronym
- LIMIT
- Status last verified
- May 2019
- First submitted
- 19 Jun 2018
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nessel I, De Rooy L, Khashu M, Murphy JL, Dyall SC. Long-Chain Polyunsaturated Fatty Acids and Lipid Peroxidation Products in Donor Human Milk in the United Kingdom: Results From the LIMIT 2-Centre Cross-Sectional Study. JPEN J Parenter Enteral Nutr. 2020 Nov;44(8):1501-1509. doi: 10.1002/jpen.1773. Epub 2020 Feb 11.
PubMed 32048312
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Lipid Peroxidation Products in Donor Human Milk- a Two-Centre Pilot Study
- ClinicalTrials.gov ID
- NCT03573531
- Acronym / sponsor ID
- LIMIT / 1718/IRASIN/1
- Conditions
- Breast Milk Collection
- Keywords
- donor human milk, lipid peroxidation, neonate, omega-3 fatty acids, omega-6 fatty acids, preterm infants, malondialdehyde
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 29 Jun 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.
This study will quantify lipid peroxidation products (malondialdehyde, 4 hydroxy-2-nonenal, hexanal, and 8-iso-PGF2α), fatty acid content, and antioxidant capacity in donor human milk sampled from two neonatal units in the UK. Comparison will be made to preterm transitional/mature milk and term mature milk.
Detailed description
The investigators have recently identified that current human milk banking practices in the United Kingdom may have the potential to increase levels of lipid peroxidation products in donor human milk. It is therefore important to quantify the extent of this increase. This project aims to quantify for the first time the levels of lipid peroxidation products in donor human milk that is provided to infants on the neonatal unit.
Donor human milk samples will be collected from two neonatal units in the United Kingdom, served by different human milk banks. Fresh mature term breast milk, collected from healthy mothers in the community, and preterm transitional/mature breast milk, collected from healthy mothers at a neonatal unit, will be used for comparison. For each group, 10 x 5 mL samples will be analysed for the lipid peroxidation products, malondialdehyde, 4 hydroxy-2-nonenal, hexanal, and 8-iso-PGF2α. The fatty acid content and total antioxidant capacity will also be measured. All analysis will be undertaken at Bournemouth University.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Donor Human Milk | – | Other: Laboratory analysisDonor Human Milk (processed by a human milk bank) Sampled at two different neonatal units in the United Kingdom Collection of 5 ml of otherwise routinely discarded donor human milk |
| Preterm Milk | – | Other: Laboratory analysisPreterm transitional or mature breast milk Sampled from healthy mothers of preterm babies (born , 37 weeks gestational age) at a neonatal unit in the United Kingdom Collection of 5 ml at a time point of routine expression |
| Term Milk | – | Other: Laboratory analysisTerm mature breast milk Sampled from healthy mothers of term babies in the community (e.g. Baby Cafes). Collection of 5 ml expressed for this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Donor human milk is donated by mothers, having a stable milk supply, to the respective milk bank from which it is requested from the neonatal units, where it is sampled. Preterm mothers will be selected from a neonatal unit in the U.K. Term mothers will be selected from the community form baby cafes and similar in the Bournemouth area.
Key inclusion criteria (3 listed)
- Donor human milk that was intended to feed an infant at a neonatal unit in the U.K will be used for this study. Donor human milk needs to be routinely discarded 24 hours after defrosting on the unit, at that point it will be used as sample for this study.
- Preterm transitional/mature breast milk will be sampled from healthy, asymptomatic mothers of a preterm baby (born < 37 weeks gestational age) as soon as a stable milk supply is established. Samples will only be obtained if there is a surplus to the babies' need.
- Term mature breast milk will be sampled from healthy, asymptomatic mothers in the community. Samples will only be obtained if there is a surplus to the babies' need.
Key exclusion criteria (3 listed)
- Donor human milk that cannot be stored on ice or in the fridge within 2 hours and cannot be frozen at -80°C within 5 hours
- For preterm and term breast milk:
- Women < 18 years Women who are not able to access the study information in English Smoking women Women with mastitis Women who delivered after clinical chorioamnionitis, or other sepsis
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 |
|---|---|---|
| Laboratory analysisAnalysis of lipid peroxidation markers (malondialdehyde, 4 hydroxy-2-nonenal, hexanal, and 8-iso-PGF2α) Analysis of fatty acid content Analysis of total antioxidant capacity | Other | Donor Human Milk, Preterm Milk, Term Milk |
Primary outcome
Lipid peroxidation markers
Time frame: 2 weeks
Analysis of malondialdehyde (TBARS, colourimetric), 4-hydroxy-2-nonenal (ELISA), hexanal (gas chromatography), and 8-iso-PGF2α (ELISA)
2 secondary outcomes
Fatty acid content
Time frame: 1 week
Antioxidant capacity
Time frame: 1 week
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 13 May 2019.
- Derived from this study: PubMed 32048312Nessel I, De Rooy L, Khashu M, Murphy JL, Dyall SC. Long-Chain Polyunsaturated Fatty Acids and Lipid Peroxidation Products in Donor Human Milk in the United Kingdom: Results From the LIMIT 2-Centre Cross-Sectional Study. JPEN J Parenter Enteral Nutr. 2020 Nov;44(8):1501-1509. doi: 10.1002/jpen.1773. Epub 2020 Feb 11.
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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.
Isabell Nessel principal investigator
Bournemouth University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk Collection, run by Bournemouth University at 3 sites in United Kingdom.
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 3 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 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Lipid peroxidation markers (time frame: 2 weeks). 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 NCT03573531, 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 13 May 2019.