The purpose of this study is to look closely at the amounts of protein that infants receive during the first month of life to determine how it affects the amount of body fat. Recent studies have shown an increasing number of preterm infants with an increased risk of obesity and other health problems later in adulthood. This study will be looking at the amount of protein a baby eats during the first month and how it affects the amount of body fat he/she has while in the hospital. We also plan to look closely at stool, urine and blood samples to study the effects of protein in the diet. There will be 120 premature babies with their mothers enrolled as participants in this study.
There will be body fat measurements done twice while in the hospital. Once around 10 days of life and once at 36 weeks of age or discharge. The body fat measurement is done by placing the baby in a small machine called a Peapod®.
All parts of your baby’s care will be the standard treatments for premature babies in the NICU. We will collect information from the medical chart. This includes body measurements, detailed nutrition information, infections treated, lab results, and date of discharge to home. We will also collect maternal information such as age, race/ethnicity, education level, insurance type and health issues that may have affected this pregnancy.
Diapers will be collected for stool samples 2 times. Once around day 10 of life and once at 36 weeks or discharge. A one-time blood sample will be collected at 36 weeks of age and at the same time routine labwork is collected. The amount of blood collected is 0.3ml (less than a 1/10th of a teaspoon).
With permission a one-time urine sample will also be collected at 36 weeks or discharge using the D3 creatine dilution method to obtain a more accurate measure of fat free mass. The nurse will administer a 0.2 mg dose of D3- creatine supplement at the same time of a routine feed either by mouth or through the feeding tube. After the supplement has been given we will collect a 1ml urine sample within 24-48 hours from a special collection urine bag that is attached to your baby and made to fit over your baby’s genital area. All stool, urine and serum samples will be placed in a sterile collection tube with their unique identifying study code and the date of collection
This study may help show how monitoring body fat can provide important information when planning for the nutritional needs of preterm babies.
The alternative is not to participate in the study.
There is no cost to participate in this study. The costs of your child’s standard medical care will be billed to you and/or your insurance company in the usual manner.
There is no payment provided for participation in this study.
May I review or copy the information obtained from me or created about me?
You have the right to review and copy your health information. However, if you decide to be in this study and sign this permission form, you will not be allowed to look at or copy your information until after the research is completed.
May I withdraw or revoke (cancel) my permission?
Yes, but this permission will not stop automatically. The use of your personal health information will continue until you cancel your permission. You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the study doctor. If you withdraw your permission, you will not be able to continue being in this study.
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