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ELIGIBILIBILITY
Q: Can my baby join?
A: We’re currently accept infants from southeastern Michigan who were
a) born prior to 37 weeks and/or at less than 2500g (5 lbs, 8 oz);
b) who are less than one year of age at time of enrollment into the study; and
c) who’ve been released from hospital care.
Q: I don’t live in southeastern Michigan; can my baby still join?
A: Yes, but we can’t offer the same level of support services and your family’s pediatrician would have to be very involved. You can e-mail us at (link) for more details.
Q: My baby has brain damage/a birth defect/is sick. Can I still join?
A: Yes, as long as your child was born prior to 37 weeks/<2500g (5 lbs, 8 oz), is less than one year of age at time of entrance into the study, and has been released from hospital care.
Q: My child is 13 months old/11 months adjusted. Can we still join?
A: At this time, only children who are less than one year of “actual” age at the time of enrollment into the study are being accepted.
Q: I am breastfeeding; can my child still participate?
Q:
I am using formula; can my child still participate?
Q:
My child has formula allergies; can my child still participate?
MEDICAL ISSUES
Q: My baby has brain damage/a birth defect/is sick. Will this fix it?
A: Participation in this study will not cure brain damage, repair birth defects, or fight infection.
Q: If I use the products being employed in this study, do I still need to go to a doctor?
A: Yes. The supplements used in this study are intended to be an “addition” to your baby’s normal health care. Babies without a pediatrician will not be accepted into the study.
COST
Q: How much does it cost?
A: Our study participants pay nothing. All support services and products are provided to them free.
Q: Someone is paying for it. Who?
A: The Preemie Growth Project is a non-profit organization funded by private charitable donations. You can help by donating here: (link)
Q: Will you reimburse my co-pays/pay when my child visits the doctor?
PRODUCTS
Q: What nutritional supplements are you using?
A: We use two different products, and we aren’t releasing the names of the products until the study is complete.
Q: Why don’t you say the name of the products you are using?
A: We’re not “advertising” for either of the companies providing the products for this study, nor do we want someone to simply read about it on the web, and then possibly use incorrect dosages, or not follow all of the safety steps the parents in our program are using.
Q: Do your participants know what they are using?
A: Yes, but they sign a confidentiality agreement.
PARTICIPANT SUPPORT
Q: I am in desperate need of formula / diapers / clothing / bedding / financial help. Can you help me?
A: We have limited resources, but will do our best to assist participants in emergency situations on a case-by-case basis with supplies, but cannot assist with finances.
Q: I am in desperate need of formula / diapers / clothing / bedding / financial help. Can you help me, even if I don’t participate in your study?
A: At this time, our limited resources are directed toward assisting our participants.
DONATIONS
Q: I am a caring, supportive person. How can I help?
A: You can donate (create link to donations page). If you are in southeastern Michigan, you can fill out a volunteer application (create link to volunteer page). And we also very much appreciate prayer support.
Q: I have baby clothing / diapers / formula / bedding that I am willing to donate. How can I get it to you?
A: Please send us a message at (e-mail address) and we will gratefully make arrangements to get it to someone who needs it.
Q: Are my donations tax-deductible?
A: We are organized under law as a Michigan non-profit and qualify under Section 501(c)(3) of the Internal Revenue Code; HOWEVER, we are currently waiting word from them that they agree with us on this designation, and until then, please assume your gift is a “non-tax deductible” gift.
STUDY DETAILS
Q: How many participants will be in your study?
A: Our goal is 200 in 2010, and 1,000 by the end of 2012.
Q: What do you expect to see as a result of this study?
A: A decrease in infant mortality rates, and faster than expected achievement of growth and developmental milestones.
Q: Is there any research backing up what you are studying?
A: Yes. This study builds on already established research. You can view some of it here (create link to page)
Q: Does this study have a formal name?
A: Yes. The current name of the study is “The Effects of Trace Mineral Supplemenation on the Growth of the Premature Neonate.”
Q: How long will the study run?
A: Between three and five years. Each child entered into the study will be followed for 36 months, which is why there is a range of time.
Q: Do you have any FDA approvals?
A: No, the compounds being used are "over the counter supplements" and as such, not under the governance of the FDA. Appropriate documentation as to content via essay has been obtained from each company providing product.
Q: Why are you testing two different compounds?
A: To determine if there are any measurable differences in results between each of them and the control group; also, one is "trace minerals only" while the other is "trace minerals plus a little extra."
Q: What are the outcome that will be measured / how often?
A: Weight, Length, Head Circumference; also, standard developmental milestone checklist, with medical history (ongoing/updated); all assessments to be performed by either home visiting pediatric nurses -or- filled out by the participant's pediatrician during weeks when infant sees pediatrician; schedule: once a week for 16 weeks; bi-weekly for 2-4 months (depending on age at entrance into study); once a month thereafter for a total of 36 months
Q: Are there target cofactors within specific metabolic pathways targeted?
A: No. This is a "pilot/preliminary" study to determine if this nutritional approach (based on pg 631 of the Textbook of Pediatric Gastroenterology & Nutrition, among other sources) can duplicate the results experienced by the twins.
Q: When does this start?
A: Target dates are to begin participant recruitment in December, 2009/January, 2010.
MORE QUESTIONS?
Q: Isn’t a classic study “double blind”? Why are you letting parents pick?
A: Preemie parents struggle with being out of control; in our study, we let the parents pick which cohort they wish to join, and we support them in their decisions.
Q: I am a professional/researcher. How can I learn more?
A: Credentialed professionals can access our data by completing an application here: (create link to application page for professionals). Please note access will be restricted at certain times while we are updating data/being reviewed by our Medical Advisory Board.
Q: I am a parent. How can I learn more?
A: Fill out an application at (create link). We know you are under a great deal of stress, and will do our best to answer your questions promptly.
Q: I want to learn more. Do you have a mailing list?
A: Yes, we do. You can sign up for it here: (create link to mailing list sign-up page)
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