X-ray is the “gold standard” for initial tube placement verification.(1) X-ray is not an option for the required maintenance checks every 4-8 hours and prior to the introduction of anything into the tube. Since no reliable, non-radiographic method exists in pediatrics to locate the distal end of a feeding tube, a combination of verification methods is used to improve the odds of placement.(2) No consensus exists among 242 pediatric hospitals in the US as to which combination of placement methods is best to use. A solution to this problem will require focused attention and development of specific protocols, possibly using new technologies.(3)

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Unmet Need In Pediatrics

 

X-ray is the “gold standard” for initial tube placement verification.(1) X-ray is not an option for the required maintenance checks every 4-8 hours and prior to the introduction of anything into the tube. Since no reliable, non-radiographic method exists in pediatrics to locate the distal end of a feeding tube, a combination of verification methods is used to improve the odds of placement.(2) No consensus exists among 242 pediatric hospitals in the US as to which combination of placement methods is best to use. A solution to this problem will require focused attention anddevelopment of specific protocols, possibly using new technologies.(3)

 

Feeding tubes are a common medical device used worldwide to provide nutrition and medication when an infant is unable to eat orally. The procedure is a blind placement of a temporary nasal (NG) or oral (OG) feeding tube passing through the esophagus and ending in the stomach. The placement of this tube is highly dependent on trained healthcare professionals or parents. In a NOVEL project at 63 hospitals, nearly 2000 subjects, revealed 61% of the enteral tubes were in the NICU population.(4)

 

Even with training, average hospital based misplacement rates for pediatrics was reported up to 40% (5) with ~2% of those placed in the pulmonary system and 59% in neonates. (6) Assessment of a feeding tubes location after blind placement is a conundrum and associated with a long history of discredited confirmation methods. Improper placements in infants can lead to death, pneumonia, lobectomy, feeding intolerances, malabsorption of medication, poor outcomes for babies and increased health costs.

 

The SurTube™ Infant feeding tube system is intended for use in patients from birth to 2 years old weighing 1.5kg to 13 kg. The 2014 US market size from 242 pediatric hospitals is estimated at 1.5 million tubes for neonates, 925,000 tubes in pediatrics with over 2.4 million total nasogastric and oral gastric tubes (7). The intended patient population would be children in hospital and home based care settings.








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