LIMIT: Investigating Lipid Peroxidation Products in Donor Human Milk

Sponsor

Bournemouth University (Other)

Overall Status

Completed

CT.gov ID

NCT03573531

Collaborator

(none)

Enrollment

Locations

4.7

Actual Duration (Months)

13.3

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Milk Collection	Other: Laboratory analysis

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

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 8, 2018

Actual Primary Completion Date :

Feb 13, 2019

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 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
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 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
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 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

Arm

Intervention/Treatment

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

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

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

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

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

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

Outcome Measures

Primary Outcome Measures

Lipid peroxidation markers [2 weeks]
Analysis of malondialdehyde (TBARS, colourimetric), 4-hydroxy-2-nonenal (ELISA), hexanal (gas chromatography), and 8-iso-PGF2α (ELISA)

Secondary Outcome Measures

Fatty acid content [1 week]
Analysis of fatty acid content (gas chromatography)
Antioxidant capacity [1 week]
Analysis of antioxidant capacity (colourimetric)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Bournemouth University	Bournemouth	United Kingdom	BH13LT
2	St George's Hospitals NHS Foundation Trust	London	United Kingdom	SW170QT
3	Poole Hospital NHS Foundation Trust	Poole	United Kingdom	BH152JB