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NCT Number: NCT03573531

Investigating Lipid Peroxidation Products in Donor Human Milk

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Bournemouth University, Bournemouth, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laboratory analysis

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Fatty acid content

    Time frame: 1 week

    Analysis of fatty acid content (gas chromatography)

  2. Antioxidant capacity

    Time frame: 1 week

    Analysis of antioxidant capacity (colourimetric)

Sponsors and collaborators

Lead sponsor

Bournemouth University

Other

Registry information

Official study title

Investigating Lipid Peroxidation Products in Donor Human Milk- a Two-Centre Pilot Study

Acronym: LIMIT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2018
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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