Dear Parents,

I am a SIDS researcher at Children’s National Medical Center in Washington, DC. I have been working on the issue of SIDS in day care settings for many years now. Babies experience a lot of change when they start day care. These changes may affect the baby’s risk for SIDS. We want to see how these changes for the baby during the weeks before and after s/he starts day care affect the baby.

I would like to study young babies, half of whom are entering day care and half of whom are at home during the day with a parent, by measuring sleep patterns and hormones that are markers for stress and circadian rhythm in infants.

Here are the criteria for participating in the study:

1. Your baby has to be less than 3 months of age when you begin the study.
2. If your baby will be entering day care, it needs to be a licensed day care center (not a family day care home), and your baby has to start at the day care center when s/he is between 60 days (2 months) and 120 days (4 months) of age.
3. Your baby has to be born full term (at least 37 weeks gestation) or with a birth weight of at least 5-1/2 pounds.
4. Your baby cannot have any medical problems that require ongoing care by a subspecialty doctor.

If you agree to participate in the study, this is what we will be doing:

1. We will ask you to sign an informed consent form, basically stating that you understand the study and what your and your baby’s roles in the study are. Someone from our research team will review this document with you.
2. We will ask you questions about yourself, your baby, and what you do at home with the baby, such as what the baby eats and where the baby sleeps. This will take approximately 10-15 minutes and can be done over the phone.
3. We will ask you to put an Actigraph watch (see picture) on your baby’s ankle for 4 weeks. If your baby will be starting day care, you will put the watch on the baby’s ankle 2 weeks before s/he starts day care. The Actigraph looks like a small watch and measures your baby’s movements, so that we can tell when s/he is asleep and when s/he is awake. The watch is waterproof and shockproof, so you do not have to take it off.
4. You will fill out a diary of the baby’s feeds and sleep times on the days that the Actigraph watch is on.
5. On 6-8 different days, we will ask you to collect your baby’s urine and the baby’s mother’s urine in the morning and the evening. We will give you a special pad (it looks like a sanitary pad) to put in the baby’s diaper to collect the urine. It does not stick to the skin or cause any pain or discomfort. You will then use a syringe (which we will give you) to draw out the urine from the pad and put it in a special container. You will need to put the urine samples in your freezer (we will give you a special box to put it in) until you are ready to send them to us. The urine will be tested for two hormones that tell us about stress levels and about your sleep and awake patterns.
6. We will remind you, by email, phone call, and or text message, on the days when you have to collect the urine. We will also remind you when you are to place the Actigraph watch on your baby’s ankle.
7. You will be in the study for approximately 4 weeks.

If you live in the Baltimore-Washington area, we will likely come to your home to bring the Actigraph watch and other study materials to you. If you do not live in this area, we can send the materials to you in the mail and provide instructions on returning it back to us (we will pay for the shipping).

Families that complete the study will receive a total of $150 ($50 at the beginning and $100 at the end). If your child is in day care, the day care center will receive a total of $50 at the end of the study. The $150 will be in the form of gift cards. (Target has been the most popular for participants in other studies; I am open to other suggestions.)

We have received approval from the Children’s National Medical Center institutional review board to assure that there are no ethical concerns with the research study. If you are currently pregnant or have a baby who is 3 months or younger, I hope that you will consider participating in this study.

If you are interested in participating, or if you have questions about the details of the study, please contact me directly. I’m happy to answer any and all questions.

Thank you very much for considering participation.

Best,

Rachel Moon, M.D.
Director, Academic Development
Associate Chief, Division of General Pediatrics and Community Health
Goldberg Center for Community Pediatric Health
Children’s National Medical Center
Professor of Pediatrics
George Washington University School of Medicine and Health Sciences
Tel: 202-476-5476
Email: rmoon@cnmc.org