Investigating Lipid Peroxidation Products in Donor Human Milk

NCT03573531 | Completed

• 2 other identifiers: 1718/IRASIN/1221198
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Milk Collection

Keywords

donor human milk; lipid peroxidation; neonate; omega-3 fatty acids; omega-6 fatty acids; preterm infants; malondialdehyde

Outcome Measures

Primary Outcomes (1)

• Lipid peroxidation markers

  Analysis of malondialdehyde (TBARS, colourimetric), 4-hydroxy-2-nonenal (ELISA), hexanal (gas chromatography), and 8-iso-PGF2α (ELISA)

  2 weeks

Secondary Outcomes (2)

• Fatty acid content

  1 week

• Antioxidant capacity

  1 week

Study Arms (3)

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

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

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

Other: Laboratory analysis

Interventions

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

Donor Human Milk; Preterm Milk; Term Milk

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bournemouth University: lead

Study Sites (3)

Bournemouth University

Bournemouth, BH13LT, United Kingdom

Location

St George's Hospitals NHS Foundation Trust

London, SW170QT, United Kingdom

Location

Poole Hospital NHS Foundation Trust

Poole, BH152JB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32048312 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Donor human milk (breast milk processed by a human milk bank) * Mature term breast milk * Preterm transitional/mature breast milk

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Isabell Nessel

  Bournemouth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 29, 2018
• Study Start: November 8, 2018
• Primary Completion: February 13, 2019
• Study Completion: April 1, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

GB (3)