S Fadavi1, I C Punwani, D Vidyasagar. 1. Department of Pediatric Dentistry (Drs. Fadavi and Punwani), College of Dentistry, University of Illinois at Chicago; and the Department of Neonatology (Dr. Vidyasagar), University of Illinois Hospital, Chicago, Illinois.
Abstract
OBJECTIVE: Previous studies demonstrated that the use of a custom-made intraoral acrylic appliance, known as a palatal stabilizing device, prevents palatal groove formation and reduces the frequency rate of accidental extubations in premature, intubated babies. In this study, we compared the effectiveness of a prefabricated palatal device with an acrylic custom-made palatal stabilizing device. Specifically, we compared the stability, fit, and retention of these two devices. DESIGN: Randomized comparative study. SETTING: Clincal trial. PATIENTS: A total of 70 medically stable, premature, intubated babies. INTERVENTIONS: A total of 70 medically stable, premature, intubated babies randomly receivedPala-nate (experimental group, n = 34) or palatal stabilizing device (control group, n = 36). MEASUREMENTS AND MAIN RESULTS: Differences among birth weight, gestational age, and period of intubation of the two groups were statistically nonsignificant at p </=.05. Although both appliances were effective in the prevention of palatal grooves, the Pala-nate was less retentive, thus requiring greater monitoring, and it was associated with a larger number of accidental extubations. The differences between the two groups were statistically significant at p </=.05. CONCLUSIONS: We concluded that the custom-made, acrylic, palatal stabilizing device was more stable and more effective in the prevention of spontaneous extubations in premature orally intubated infants.
RCT Entities:
OBJECTIVE: Previous studies demonstrated that the use of a custom-made intraoral acrylic appliance, known as a palatal stabilizing device, prevents palatal groove formation and reduces the frequency rate of accidental extubations in premature, intubated babies. In this study, we compared the effectiveness of a prefabricated palatal device with an acrylic custom-made palatal stabilizing device. Specifically, we compared the stability, fit, and retention of these two devices. DESIGN: Randomized comparative study. SETTING: Clincal trial. PATIENTS: A total of 70 medically stable, premature, intubated babies. INTERVENTIONS: A total of 70 medically stable, premature, intubated babies randomly received Pala-nate (experimental group, n = 34) or palatal stabilizing device (control group, n = 36). MEASUREMENTS AND MAIN RESULTS: Differences among birth weight, gestational age, and period of intubation of the two groups were statistically nonsignificant at p </=.05. Although both appliances were effective in the prevention of palatal grooves, the Pala-nate was less retentive, thus requiring greater monitoring, and it was associated with a larger number of accidental extubations. The differences between the two groups were statistically significant at p </=.05. CONCLUSIONS: We concluded that the custom-made, acrylic, palatal stabilizing device was more stable and more effective in the prevention of spontaneous extubations in premature orally intubated infants.