Pediatric Annals

PRODUCT REPORT

Abstract

The Product Report was designed to provide pediatricians with up-to-date information on new medical equipment, office accessories, etc. Listings are made up from unsolicited press releases from the manufacturer. They are neither advertisements nor endorsements.

Recomblvax HB®

Recombivax HB, the first genetically engineered human vaccine to be licensed in the world, is now available in the United States for use in preventing hepatitis B infection, according to the vaccine's manufacturer, the Merck Sharp & Dohme (MSD) division of Merck & Co., Inc.

Licensed by the United States Food and Drug Administration in July, 1986, Recombivax HB was developed by the Merck Sharp & Dohme Research Laboratories (MSDRL). The vaccine manufacturing process uses recombinant DNA technology to produce hepatitis B antigen (the substance that stimulates immunity) from a genetically engineered form of baker's yeast.

In clinical studies, Recombivax HB has been shown to induce protective levels of antibodies against hepatitis B virus infection in more than 90% of 564 healthy adults and teenagers who received the recommended three-dose regimen.

The protective efficacy of the vaccine has been demonstrated in newborn children of mothers who are chronically infected with the hepatitis B virus. The infants received a single dose of hepatitis B immune globulin at birth, followed by the recommended three doses of the new vaccine. Efficacy in preventing chronic hepatitis B infection was 94% among 93 infants studied at six months and 93% among 57 infants studied at nine months.

For more information, contact Roy W. Walker, Merck Sharp & Dohme, West Point, PA 19486; telephone (215) 661-5864.

SleepTight Eases Colic Symptoms In Infants

For years doctors and scientists have not known what causes colic or how to treat it effectively A new product called SleepTight, which simulates the motion of a car ride, has been shown to lessen colic symptoms in 58 of the 60 infants tested during the three-year Infant Colic Research Project, supported by the National Institute of Child Health and Human Development (NICHD). The study also found that 85% of the babies stopped crying within four minutes of using SleepTight.

This is welcome news to parents who cope with colicky babies. Although there are no firm statistics on the number of infants affected by colic, physicians estimate that 9% to 23% of infants up to 3 months of age experience colic.

SleepTight, a patented medical device, consists of a vibration unit and a sound unit that simulate a car ride at 55 miles per hour. Mounted underneath the crib, the vibration unit gently rocks the crib while the other unit, attached to the side of the bed, provides the rushing sound of wind passing a closed car window.

The idea for the device came from a desperate parent. Armando Cuervo began work on this project five years ago after his own son, Andrew, had colic and kept Cuervo and his family awake for hours on end.

"This was the worst experience I have ever had in my life," says Cuervo. "One night at 2:30 in the morning I decided I couldn't take it anymore. I called the doctor and told him what was happening. I was ready to commit child abuse. I needed help 11 told him to do something about this child. He agreed to meet me and the baby at his office."

A strange thing happened on the way to the doctor. Cuervo noticed his son's crying began to decrease. By the time they arrived at the doctor's office the baby was sound asleep. Thus, the idea was born to make a device that would recreate that car ride. After consulting with several experts, Cuervo…

The Product Report was designed to provide pediatricians with up-to-date information on new medical equipment, office accessories, etc. Listings are made up from unsolicited press releases from the manufacturer. They are neither advertisements nor endorsements.

Recomblvax HB®

Recombivax HB, the first genetically engineered human vaccine to be licensed in the world, is now available in the United States for use in preventing hepatitis B infection, according to the vaccine's manufacturer, the Merck Sharp & Dohme (MSD) division of Merck & Co., Inc.

Licensed by the United States Food and Drug Administration in July, 1986, Recombivax HB was developed by the Merck Sharp & Dohme Research Laboratories (MSDRL). The vaccine manufacturing process uses recombinant DNA technology to produce hepatitis B antigen (the substance that stimulates immunity) from a genetically engineered form of baker's yeast.

In clinical studies, Recombivax HB has been shown to induce protective levels of antibodies against hepatitis B virus infection in more than 90% of 564 healthy adults and teenagers who received the recommended three-dose regimen.

The protective efficacy of the vaccine has been demonstrated in newborn children of mothers who are chronically infected with the hepatitis B virus. The infants received a single dose of hepatitis B immune globulin at birth, followed by the recommended three doses of the new vaccine. Efficacy in preventing chronic hepatitis B infection was 94% among 93 infants studied at six months and 93% among 57 infants studied at nine months.

For more information, contact Roy W. Walker, Merck Sharp & Dohme, West Point, PA 19486; telephone (215) 661-5864.

SleepTight Eases Colic Symptoms In Infants

For years doctors and scientists have not known what causes colic or how to treat it effectively A new product called SleepTight, which simulates the motion of a car ride, has been shown to lessen colic symptoms in 58 of the 60 infants tested during the three-year Infant Colic Research Project, supported by the National Institute of Child Health and Human Development (NICHD). The study also found that 85% of the babies stopped crying within four minutes of using SleepTight.

This is welcome news to parents who cope with colicky babies. Although there are no firm statistics on the number of infants affected by colic, physicians estimate that 9% to 23% of infants up to 3 months of age experience colic.

SleepTight, a patented medical device, consists of a vibration unit and a sound unit that simulate a car ride at 55 miles per hour. Mounted underneath the crib, the vibration unit gently rocks the crib while the other unit, attached to the side of the bed, provides the rushing sound of wind passing a closed car window.

The idea for the device came from a desperate parent. Armando Cuervo began work on this project five years ago after his own son, Andrew, had colic and kept Cuervo and his family awake for hours on end.

"This was the worst experience I have ever had in my life," says Cuervo. "One night at 2:30 in the morning I decided I couldn't take it anymore. I called the doctor and told him what was happening. I was ready to commit child abuse. I needed help 11 told him to do something about this child. He agreed to meet me and the baby at his office."

A strange thing happened on the way to the doctor. Cuervo noticed his son's crying began to decrease. By the time they arrived at the doctor's office the baby was sound asleep. Thus, the idea was born to make a device that would recreate that car ride. After consulting with several experts, Cuervo designed SleepTight. Cuervo, who has a bachelor's degree in chemistry and a master's in business administration from Washington University in St. Louis, sought funds from the NICHD to test scientifically the effectiveness of the product and, if possible, improve its design and performance.

"NICHD is particularly proud of this accomplishment because it is the first product under its Small Business Innovation Research Grants program to be marketed directly to the public for use. Other devices or services invented or funded under the program have mainly aided scientists in their research," said Dr. Duane Alexander, NICHD director.

For more information, write SleepTight at 3613 Mueller Road, St. Charles, MI 63301 or call 1-800-325-3550.

Vlrogen® Herpes Slide lest

Virogen® Herpes Slide Test is the first rapid latex immunoassay for the detection of herpes simplex virus (HSVJ antigens. This simple latex agglutination test can be performed with specimens taken directly from active lesions or from cell culture to provide a definitive identification of HSV antigens. In 30 minutes, HSV identification can be made using an identical test procedure for both the direct and cell culture tests.

For either the direct specimen or cell culture test, the procedure requires pipetting each sample, along with appropriate controls, into separate wells of a disposable slide, adding Specimen Buffer/Absorbent to each well, and rotating for 5 minutes. The Reagent and Control Latexes are then added, and the slide is rotated for an additional 25 minutes. Virogen Herpes Slide Test requires sterile 50 µl, 10µl, and 1.0 ml pipettes, a standard rotator capable of 140 to 160 rpm, virology sampling materials, a table-top centrifuge for the direct test, and routine culturing equipment for the culture test.

The Virogen Herpes Slide Test procedure provides an alternative to the difficulties of mounting, fixing, staining, and reading fluorescent immunoassays and to the more tedious handling requirements of currently available EIA assays for herpes simplex virus. The latex agglutination endpoint allows visual interpretation under a conventional lamp and eliminates the need for a fluorescence microscope or spectrophotometer.The 30-minute test time and overall simplicity make the test suitable for use in the hospital and reference laboratory as well as the physician's office.

Virogen Herpes Slide Test is available from Wampole Laboratories in a 100 test kit size (#18H4). Each Virogen Herpes Slide Test also includes a complimentary slide cover. Stored refrigerated, all kits are stable for up to 12 months. For more Information, call your local distributor, or our Wampole Laboratories Representative at (800) 257-9525. (in NJ, (609) 665-6000.

Ventrescreen Mono Test

The unique features of the Ventrescreen Mono Test are its simple color change to indicate positive results and its speed. This enzyme immunoassay is a 5 minute test that turns blue if heterophile antibody is present.

To perform the test, just add sample and reagent to antigen coated tube and wait 3 minutes. If it turns blue, heterophile antibody is present. All reagents are provided in dropper vials. This assay is offered in 20 and 100 test kits.

For further information, contact Ventrex Laboratories, Inc., 217 Read Street, Portland, ME 04103; (800) 341-0463 or (207) 773-7231.

New Catalog of Medical Toys

A bear with braces, cast or eye patch and a doll with helmet and chest protector are part of the array of medically-oriented toys in a new catalog from Pediatric Projects Incorporated.

The nonprofit group focuses on therapeutic and educational toys and books that help children understand disability and illness, whether it is their own or those of siblings or classmates

The bears, called Exceptional Animals, are soft and huggable, and each has an accurately rendered helping aid for mobility or treatment that children can safely play with. Doctors and nurses use the bears to explain treatment procedures and show the appliance on the bear before placing it on a child patient.

Anatomical dolls in the catalog include the soft-sculpture Zaadi Dolls, with a torso and back that open to show color-coded, embroidered and appliqued muscles, bones, internal organs, and systems. Designed for visual and tactile learning, the dolls also have kidney transplants, removable hair, ureter implants, removable hernia and appendix, and space to place a broken or healed bone.

Catalogs are free, although contributions are always welcomed for this nonprofit organization. Write Pediatric Projects Incorporated, P.O. Box 1880, Santa Monica, CA 90406-1880, or call (213) 828-8963.

10.3928/0090-4481-19880101-11

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