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Subject:
From:
Judy Hopkinson <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Tue, 13 Jan 2004 14:47:18 -0600
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Hi Meg,
I do not know whether there is an Institutional Review Board for the
Protection of Human Subjects at the institution.  If you so, they should be
able to provide guidance after hearing specifics of the proposed study
procedures.

In general, it is ethical to offer one group "standard care" and to offer a
randomly determined intervention group additional care.  The "standard care"
group cannot be restricted from accessing additional services (equipment or
counseling) from another source.  That is, if mothers have a way to obtain
care or equipment from an alternate source, that option cannot be ethically
denied to them.  However, control mothers would still have to access
additional care on their own initiative and using their own resources just
as they do currently.  In reality, the study tests the impact of the
institution OFFERING ACCESS to additional care.  It does not test the impact
of the mother UTILIZING said care.

This is a good thing -  because the institution can only control what it
offers to mothers - not what the mothers do.  Analysis of the results would
be done by "intent to treat".

If the investigators record which mothers in each group do obtained pumps
and actually do follow the milk expression protocols, then it might be
possible to evaluate the impact of the treatment received -- BUT this is
more complicated.  Because of potential confounding variables, it would be
very easy to misinterpret the results if the later analysis is done
incorrectly.

Wishing you good luck and good science,
Judy Hopkinson, Ph.D.
Assistant Professor
Children's Nutrition Research Center at
Baylor College of Medicine
1100 Bates St.
Houston, Texas 77030

Date:    Tue, 13 Jan 2004 19:34:42 +0400
From:    Pascoes in Dubai <[log in to unmask]>
Subject: Research proposal

My friend works in a hospital  with a NICU that cares for about 30 new
patients every month. She is writing a research proposal for funding to
assess the impact on breastfeeding success and milk volumes, by
incorporating a milk expression program into early post partum care of
mothers with babies in the NICU-by the provision of hospital grade breast
pumps to take home for as long as necessary, support and information.

This is opposed to leaving mothers to manage with the standard NICU
lactation care, which is minimal and not highly skilled, and offers breast
pump availability on the ward only, for mothers visiting their baby/ies.

Is it possible for this question to be addressed in a randomized trial?
If randomization is not an option can anyone suggest another study design?

We are concerned that there are serious ethical implications in denying
pumps to mothers in the control group when there are in fact pumps
available.

Any suggestions greatly appreciated.
Meg Kingsley IBCLC
Dubai UAE


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