The aim of this study is to better understand the role of mammary lactation physiology and breast composition in regulating breast milk transfer during milk extraction. The secondary aim is to validate the performance of diffuse optical…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
Borstvoeding
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are 1) the flow rate and total milk volume produced
during one milk extraction with a breast pump and its relation to 2) the amount
of glandular and adipose tissue inside the breast, and 3) the hemodynamics
inside the breast, which will be studied by (changes in) the oxygen saturation
and the available haemoglobin inside breast tissue.
Secondary outcome
The secondary outcome is the validation of DOSI with MRI for the measurement of
the amount of glandular and adipose tissue inside the breast.
Background summary
Breastfeeding offers many benefits for mothers and children. Unfortunately, not
every mother who wants to breastfeed, has the opportunity to feed her child
herself. One of the most common reasons to stop breastfeeding is (the
perception of) too little milk production, this is called lactation
insufficiency. Until now, little is known about the causes of lactation
insufficiency and the influence of the breast physiology on milk production.
Study objective
The aim of this study is to better understand the role of mammary lactation
physiology and breast composition in regulating breast milk transfer during
milk extraction. The secondary aim is to validate the performance of diffuse
optical spectroscopic imaging (DOSI) against magnetic resonance imaging (MRI)
for this purpose. DOSI has the potential to be a more accessible and
informative method for research into lactation physiology compared to other
imaging modalities.
Study design
Observational
Study burden and risks
The test subject does not undergo any invasive, painful or harmful actions. The
non-invasive DOSI measurements in this study are based on the use of low-power
light. These DOSI measurements are painless, safe and do not affect the
physiology of the breast. The DOSI probe is similar in size and design to an
ultrasound probe. During the measurements, the DOSI probe is gently moved over
the breast and scans a small surface with a laser beam. The load per subject is
limited to a one-time measurement session that will take only about 1.5 to a
maximum of 2 hours. The test subject determines the moment and day of the
measurement session so that the natural course of breastfeeding is not
disturbed.
The following measurements will be performed:
DOSI.
Before and after milk extraction with a breast pump, a DOSI scan of one entire
breast is made. One measurement will take approximately 10 minutes, depending
on the breast size. During the measurement, the subject lays still in a
relaxed, supine position.
In addition, a continuous DOSI measurement is made at one location on the
breast during milk extraction (lactating group) or a 10-minute period
(non-lactating group).
MRI.
Before and after milk extraction with a breast pump, a MRI scan is made of the
breasts. The MRI scan takes approximately 30 minutes.
No contrast agent is used for the MRI measurement, which makes the measurement
non-invasive. All scans are made under the supervision of an experienced
technician. During the measurement, the subject will lie in the MRI scanner for
a maximum of 30 minutes.
All surfaces that are in contact with the subject during the DOSI and MRI
measurement are sterilized before and after each measurement.
Participation in this study does not provide any direct benefit to the
subjects. When the outcome of this study provides more insight into lactation
physiology, mothers who experience lactation problems can potentially receive
improved aid in the future.
De Horst 2
Enschede 7522LW
NL
De Horst 2
Enschede 7522LW
NL
Listed location countries
Inclusion criteria
Group I
• Lactating women
• Between 18 to 45 years
• 0.5 to 12 months postpartum
Group II
• Non-lactating women
• Between 18 to 45 years
• >9 months postpartum of pregnancy
• >9 months post-breastfeeding of pregnancy
Exclusion criteria
Group I
• Breast augmentation, reduction, reconstruction or other procedures
• Breast tattoos or piercings
• Known breast disease at time of the experiment, e.g. mastitis
• Problems with breastfeeding at the time of experiment, e.g. mastitis
• Pregnancy
• Allergy for (medical) tape
• Not eligible for MRI, see F1. Vragenlijst Screening MRI. This includes having
a:
• Pacemaker
• Implantable cardioverter-defibrillator (ICD)
• Hearing implant
• Drug pump
• Neurostimulator
• Claustrophobia
Group II
• Breast augmentation, reduction, reconstruction or other procedures
• Breast tattoos or piercings
• Known breast disease at time of the experiment
• Pregnancy
• Was pregnant or breastfeeding less than 9 months prior to moment of
measurement (due to an expected difference in breast tissue composition)
• Allergy for (medical) tape
• Not eligible for MRI, see F1. Vragenlijst Screening MRI. This includes having
a:
• Pacemaker
• Implantable cardioverter-defibrillator (ICD)
• Hearing implant
• Drug pump
• Neurostimulator
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL84865.091.23 |