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"The CHIME Study"

The Collaborative Home Infant Monitoring Evaluation (CHIME) study is an NIH funded, multi-center study which began in 1991. We are hopeful that it will continue until August, 1999. The study was mandated by Congress to answer questions about the possible role of home infant monitors in preventing SIDS. We all know that home monitors have not prevented SIDS, and have probably not even reduced the incidence of SIDS. Further, home monitors have never been scientifically proven to "protect" infants who use them from death. Therefore, this study was instituted to try to determine what home monitors do.

The most convincing scientific study to prove that home monitors work would be to take a very large group of infants in a group of interest; for example, SIDS siblings. One would divide the group into two halves. One half would get a working home monitor. The other group would get a "placebo" home monitor (one that looks like a real monitor and alarms randomly [so you think it works], but which does not actually alert caregivers to an apnea or low heart rate). Neither the family nor the local physician caring for the child would know whether he/she was on the real or placebo monitor. After several thousand babies had been enrolled, the scientists would then see which group had the most deaths. I suspect that few, if any, of you would agree to enroll in this study. Therefore, it will never be done.

Instead, CHIME took a different approach. They decided to see what happens to babies who are placed on infant monitors, and compare them to a control group. The goals of the study are to find out what types of events these babies have, how many they have, whether they can be predicted, and whether they are harmful. CHIME designed a sophisticated home monitor which is actually a computer. It can record central and obstructive apneas, low heart rate, oxygen levels in the blood, and the baby's position. The strength of this study is that it is the first time so much information is collected on babies in their homes for a full 6-months. In addition, babies also have analysis of a cry which is recorded, developmental evaluations, and a polysomnogram. A wealth of other medical and demographic data are also collected. We believe this study will provide important new information that will be important to the understanding of SIDS.

CHIME studies four groups of infants: 1) healthy term infants without a family history of SIDS [controls]; 2) SIDS siblings; 3) Apparent life-threatening event [ALTE]; and 4) Preterm infants. There are five clinical sites, which are the only places babies can be enrolled: Los Angeles, Toledo, Honolulu, Cleveland, and Chicago. You would have to call the nearest site to see if you live close enough to participate. A number of visits to the CHIME Clinic are required, and a number of home visits are made by respiratory therapists to download the computer's memory.

We would welcome inquiries from anyone interested in participating in the CHIME study in any of the five clinical sites. We are especially in need of control infants. You could call Lucy Kunzman, the CHIME Research Nurse at Children's Hospital Los Angeles, to ask about the study in the Southern California area, or for the name of the clinical site nearest to you [phone: 213/669-2101].

I hope this is helpful. Thank you.

Tom Keens
Children's Hospital Los Angeles

There have been a number of questions about enrolling subsequent babies in the CHIME Study.

The CHIME Study is a fairly intense 6-month commitment, plus a visit at one-year of age. Babies must use the CHIME Monitor, which is bigger and has more leads than a conventional monitor, for 6-months. Babies must also be seen at one of the Clinical Sites (Los Angeles, Honolulu, Chicago, Cleveland, and Toledo) on at least 5 clinic visits, plus have an overnight sleep study at a site. In addition, because the CHIME Monitor is a computer, babies enrolled need to be near a Clinical site so investigators can visit the home every 2-4 weeks to download the computer from the monitor.

While we would love to enroll all of your babies, from a practical point of view, it is unlikely that your baby can be enrolled unless you live near a Clinical site. However, each Clinical Site makes its own decision about families that may live near, but not in the city. For example, in Los Angeles, we will enroll families in Los Angeles, Orange, San Diego, and parts of Riverside and San Bernardino counties.

For more specific information, you may call the Research Nurse Coordinators at the Clinical Site nearest to where you live, as follows:

Los Angeles: Lucy Kunzman 213/669-2101.
Honolulu: Linda Kapuniai 808/973-3006.
Chicago: Sheilah Pearsall 312/942-2723.
Cleveland: Roberta O'Bell 216/459-4944.
Toledo: Mary Ann Oess 419/471-5620.

I hope this helps. Thank you all for your enthusiasm and interest in the CHIME Study. Those of us involved in it are very excited about it, and we are hopeful that important information will be derived from it. Thank you.

Tom Keens
Children's Hospital Los Angeles

01/25/97

The CHIMES project in Boston (and probably the other sites) has a device it used to determine the position of the infant. I would encourage any one interested to contact on of those programs to learn what is currently available and how it detects position.

Jodi Shaefer
Center for Infant and Child Loss
Baltimore, MD

Jodi:
As 1 of the CHIME sites, I am responding to your question. As a part of the CHIME home memory monitor, we are using a small device called an accelerometer to determine position. The device is placed on the diaper, and sends a signal into the monitor that distinguishes between supine, prone, or side position. Although it is too early to say whether we can or should use a position sensor for all home monitors, it is providing valuable information to the CHIME project regarding the relationship between sleep position and monitor events. At present, this cannot be done with any other home monitor. Stay tuned for some results soon.

I hope this is helpful.

Dr. Carl Hunt
CHIME, at Medical College of Ohio

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