This study aims to assess the safety and user acceptance (comfort and satisfaction with pumping program) of a modified Symphony program card, the INITIATE 2.0.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
post natale borstvoeding
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Occurrence of Adverse Events
o recorded by nurses/LC into the CRF
Comfort while pumping
o assessed by the necessity of reducing the vacuum strength during pumping
(binary outcome). It is expected that mothers should not need to change the
vacuum strength when using the new program card
Secondary outcome
* Comfort while pumping
o measured by maternal questionnaire
* Feeling of breast fullness/emptiness before and after pumping with the
respective pumping programs
o measured by maternal questionnaire
* Satisfaction with pumping programm
o measured by maternal questionnaire
* User acceptance on pumping time
o measured by maternal questionnaire
* Difference of total volume expressed after 15 min INITIATE and, after
additional 5 min MAINTAIN with
Symphony PLUS program card
o measured by weighing the pump set (kit and bottle) after 15 and 20 min
* Difference of total volume expressed between the standard of care approach
and the new INITIATE 2.0
program card
o measured by weighing the pump set (kit and bottle) after 20 min
* Trend in milk expression from Days 1 - 4 - compared within the volume
measurements (15, 15+5, 20
min of pumping)
o measured by the means of the volume expressed in the single pumping sessions
during the
different days
* Level of vacuum used (adjusted) by the user throughout the pump sessions
o measured through the data logger
Background summary
The study hypothesizes that mothers who are both breastfeeding and pumping in
the first
days report improved comfort levels with the new Symphony program card INITIATE
2.0
compared to the standard of care.
Medela received market feedback from staff in maternity units who were
supporting mothers
to express their milk in addition to breastfeeding their infant. The feedback
consisted of a)
that as the pattern progresses, pre-programmed vacuum changes appeared to cause
discomfort and b) that the INITIATE 1.0 pattern on the Symphony PLUS program
card did
not extract enough milk when clinical/physiological signs indicated that milk
was present.
This study aims to investigate whether the proposed changes to the INITIATE 2.0
program
card (see chapter Device Description) lead to an improvement in comfort during
pumping as
well as increased milk removal during a pumping session.
The results of this study will provide important information that a) validates
the proposed
changes as well as b) builds clear recommendations for which vacuum level
should be used
for Symphony program cards in this population.
Study objective
This study aims to assess the safety and user acceptance (comfort and
satisfaction with pumping program) of a modified Symphony program card, the
INITIATE 2.0.
Study design
Prospective, comparative, confirmatory, Proof of Concept.
Study burden and risks
There are no follow-up visits.
There are no lab measurements.
There are no radiological or other examinations.
The risks are minimal.
The investigational device is a class IIa device. Differences to the comparable
device are an
extension of the INITIATE program by 5 min to the current 15 min and, lowering
some
vacuum levels within the first 15 min of the program.
Lättichstrasse 4b
Baar 6340
CH
Lättichstrasse 4b
Baar 6340
CH
Listed location countries
Age
Inclusion criteria
1. Subject * 18 years old
2. Infant was born maximum 4 (96 hours) days ago
3. Subject aims to provide breastmilk for the baby through breastfeeding.
At least 50% of the milk removal sessions in the last 24hrs were breastfeeds.
This means:
In the last 24 hours, the mum should have been stimulating her
breasts:
100% baby (Include)
75% baby 25% pump (Include)
50% baby 50% pump (Include)
25% baby 75% pump (exclude)
100% pump (exclude)
4. Subject has an indication to pump for reasons such as:
a) infant feeding ineffectively, for example because of nipple
pain/soreness, or other.
b) infant weight gain issues
c) infant formula supplementation
d) maternal risk factors for delayed milk 'coming in'
5. The subject signs the informed consent documentation
Exclusion criteria
1. Woman is exclusively pumping
2. Woman is experiencing a mastitis event
3. Woman is still breastfeeding with the previous child
4. Woman has been breastfeeding in the last 6 months
5. Woman received morphine pain medication in the last 8 hours
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04619212 |
| CCMO | NL75613.100.20 |