Clinical Trials

As part of your child’s care, he/she may be invited to participate in one of the many Clinical Research Protocols we have at Mount Sinai. If your child meets specific criteria for enrollment, food challenges will be performed in our General Clinical Research Center (GCRC). All clinical protocols carried out in the GCRC are supported through grants from the National Institutes of Health (NIH). As a result, there is no cost either to you or your insurance carrier.

The GCRC is located on the second floor of 1184 Fifth Avenue. This patient care unit provides space for both inpatient and outpatient care. The GCRC is staffed by Nurse Practitioners who will be working together with our Clinical Research Coordinators in supervising your child’s food challenge.

Some of our Clinical Research Protocols include:

• History and course of peanut and nut protein allergy
• Characteristics of cow milk allergy
• Tolerance of processed milk and egg protein in the diet
• Food Protein-Induced Enterocolitis Syndrome
• Immune responses that casue food allergy

Food Challenges

What to Expect
Two types of challenges are done at Mount Sinai. These are done to determine if your child still has an allergy to a particular food, or to determine if your child can safely eat a food.

Double-Blind Placebo-Controlled Food Challenge
For these challenges, the patient, family, physician and nurse are blinded to the contents of the challenge. This type of challenge is given in two sessions, one in the morning and the other at lunchtime. Only the dietitian who prepared the challenge knows if it is the real food or the placebo. The food being challenged is hidden in another food or drink that is known to be safe for your child. Prior to your visit, the dietitian will speak with you about your child’s food preferences in order to provide a substance that your child will take most readily.

Open Challenge
For this type of challenge, the food is given to the patient in a “normal serving” amount. It is not hidden in any way, so all are aware of the food being given. A challenge is not considered to be negative until the open challenge is eaten without symptoms.

Challenge Procedure

1. In most cases we will ask that you arrive at the hospital at 7:30AM. This allows the actual challenge to begin at approximately 8:30AM.
2. It is best that your child have nothing but sips of water for two hours prior to the challenge. Some children cannot wait this long to eat. In this case, we allow a light (approximately ½ portion) breakfast to be eaten by 7:00AM. This is important in order to avoid food in the stomach from delaying the absorption of the challenge substance.
3. A saline-lock is necessary for most challenges. The heparin-lock will be inserted prior to beginning the challenge. This is an intravenous access device that allows for blood to be drawn and for medications to be given if they are needed. EMLA cream (a local anesthetic) is applied to the skin prior to the heparin-lock insertion to decrease the pain from the needle stick.
4. The challenge substance is fed to your child in very small doses, at fifteen-minute intervals. The purpose of this is to closely observe your child for any sign of a reaction. We are able to stop the challenge and treat a reaction before the child ingests the entire serving. It takes approximately 1-1/4 hour to complete each portion of the double blind placebo controlled challenge. Meals will be provided for your child after each challenge.
5. Emergency medications such as Epinephrine and Benadryl are prepared and ready throughout the challenge period.
6. If a reaction occurs, we will observe your child for a period of four hours before discharge.
7. If your child completes the double blind challenge without reaction, he/she will have an open challenge to that food. This usually occurs around 3:00PM. We will continue to observe your child for two hours after the open challenge.
8. We encourage you to bring any toys, games or videos to help your child feel more comfortable while at the hospital.

We hope that these points will help to answer some of your questions about food challenges. Please do not hesitate to call us at (212) 241-5548 if you have any other questions or concerns that you would like to discuss.