Clinical trial NCT03573531: Investigating Lipid Peroxidation Products in Donor Human Milk
Official title: Investigating Lipid Peroxidation Products in Donor Human Milk- a Two-Centre Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Milk Collection
Keywords: donor human milk
lipid peroxidation
neonate
omega-3 fatty acids
omega-6 fatty acids
preterm infants
malondialdehyde
Lead sponsor: Bournemouth University
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Lipid peroxidation markers
timeFrame: 2 weeks
Secondary outcomes:
measure: Fatty acid content
timeFrame: 1 week
measure: Antioxidant capacity
timeFrame: 1 week
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Bournemouth University
city: London
country: United Kingdom
facility: St George's Hospitals NHS Foundation Trust
city: Poole
country: United Kingdom
facility: Poole Hospital NHS Foundation Trust
Study officials:
affiliation: Bournemouth University
name: Isabell Nessel
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.