Jim Kling

October 04, 2010

October 5, 2010 (San Francisco, California) — Use of a pharyngeal electrical stimulation device (VitalStim, Empi Inc.) improves swallowing in preterm and term infants in the neonatal intensive care unit (NICU), according to a study presented here at the American Academy of Pediatrics 2010 National Conference and Exhibition. Neonates were also less likely to require a gastrostomy tube when the device was employed.

Feeding problems are a common complication in infants in the NICU, noted John Patrick Cleary, MD, a neonatologist and director of extracorporeal membrane oxygenation and cardiovascular intensive care at the Children's Hospital of Orange County, in California, who presented the research. Delays in feeding can prolong an infant's hospital stay and can require insertion of a gastrostomy tube.

VitalStim electrical stimulation of the pharyngeal muscles is currently approved by the US Food and Administration for treating dysphagia, or swallowing difficulty. There is evidence that it improves swallowing in adults with stroke or throat cancer and in older pediatric patients with swallowing problems. The researchers sought to study its application in neonates.

"NICUs in general are seeing the sickest of the sick and premature babies who already have complications. One of the major determinants of why they're in the hospital is a delay in learning to feed, or feeding problems, or problems with safety of feeding," Dr. Cleary told Medscape Medical News.

Infants in the study were at least 35 weeks of gestation and taking no more than 25% of feeding volume by mouth in spite of previous dysphagia therapy. The researchers randomized 18 patients to continue standard dysphagia therapy combined with sham treatment or to continue standard therapy with twice-daily pharyngeal electrical stimulation.

To evaluate results, the researchers used feeding volume, the Neonatal Oral–Motor Assessment Scale, and a radiologic swallow study. Therapists, radiologists, nurses, and treating physicians were blinded. After 2 weeks, patients in the active treatment group had a higher percentage of feeding by mouth than those in the control group (64% vs 29%; P < .05), and were less likely to meet the criteria for gastrostomy (1 of 9 vs 7 of 9; P < .05). Safety of feeding also improved in the treatment group (P < .05).

"There was both statistically and clinically significant improvement in feedings. There's a possibility that such procedures could get patients home sooner or avoid surgical gastrostomy tubes and the problems that come with those," Dr. Cleary said.

"It's a very important study. Feeding difficulties are quite prevalent in preterm infants. Like many areas of neonatology, we're trying to adapt adult-tested therapies in the newborn field," said DeWayne Pursley, MD, MPH, chief of neonatology at Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, Massachusetts, who attended the session.

The most critical question is safety, and then efficacy, according to Dr. Pursley. He doesn't believe that the technique is ready for wide adoption. "I think [Dr. Cleary and colleagues are] approaching that area of inquiry very carefully in trying to address both those areas. There's quite a way to go in trying to determine if this is a therapy that can be safely and effectively incorporated into newborn care."

The study did not receive commercial support. Dr. Cleary and Dr. Pursley have disclosed no relevant financial relationships.

American Academy of Pediatrics (AAP) 2010 National Conference and Exhibition: Abstract 10905. Presented October 2, 2010.


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