LuAnn Smith asks for input about a study on nipple shields and infant growth
in the first month of life.

I assume you would recruit mothers who are already using shields (whether
for a selected group of indications or all indications) and then divide them
into two groups: 'advised to pump routinely 3-4 X daily and give hindmilk'
as per your post, and 'not advised to pump routinely etc', or perhaps
'advised to pump only if they perceived their breasts to have been poorly
drained', and then follow them closely for the entire month.  I think it
could be defended ethically.

By closely, I mean twice a week, with recording of accurate weights for the
babies, and recording of all feeding sessions, wet diapers and stools and
pumping sessions for the entire month.  If any mothers stopped breastfeeding
or stopped using shields during this time, for whatever reason, it would
need to be recorded too.  All episodes of breast problems, like mastitis and
soreness, should be recorded.  Maybe these regimens influence the continued
need for shield use in one direction or another, and that should be
determined.  I also assume you would be trying to wean the babies off the
shields at every contact.  It would be unethical to keep babies on shields
for the sake of seeing what happens.  But trying to find out the safest way
of using shields until they can be discontinued, is an admirable goal.  If
there are differences in the rate of successful weaning from shields, or in
the time frame for when it happens, between the groups, that would really be
worth knowing.

Obviously, if a baby in one group or another is not thriving, you would need
to alter the advice given to the mother about how to ensure adequate intake.
All such events would be recorded and accounted for in your data analysis.
It would be vital to know whether poor gain occurs more often in one group
than the other.

The mothers would need to keep a log of how often they pumped, in both
groups.  Note that dividing them into groups doesn't mean that they are
bound by oath to comply with the planned treatment regimen.  But when you
analyze the results, you have to analyze them by 'intent to treat', and not
by whether or not they pumped.   The mothers are divided into groups at the
outset.  They can not change from one group to the other, based on
compliance.

This way, you would learn whether 'preventive' pumping helped maintain
supply better than pumping as needed, as determined by maternal perception
or by weight gain in the baby.  You could learn how acceptable the advice
was to your research subjects.   And with twice a week contacts you don't
risk compromising BF or infant growth.

We really need this knowledge.  Hope you can carry out the study.
Rachel Myr
not the most gung-ho shield fan in
Kristiansand, Norway

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