Initially, recruitment was difficult owing to the institution of family-centered care policy, compounded by provider variability with feeding therapeutic strategies, and lack of provider and parental support for randomization.
#Above and beyond group therapy download trial
Originally, this study was designed as a randomized clinical trial to compare the effects of thickened formula vs nipple flow change feeding modifications in infants undergoing VFSS evaluation. The study was registered on clinical : NCT02583360. In accordance to institutional guidelines and regulations involving human subjects, the protocol was approved by the Institutional Review Board at Nationwide Children’s Hospital, Columbus, OH (Supplement). This is an observational cohort study conducted between 20 at a single tertiary all-referral center at the Nationwide Children’s Hospital, Columbus, OH, in infants referred for feeding difficulties and VFSS evaluation. A sub-aim was to test the hypothesis that infants with penetration or aspiration have distinct clinical and motility outcomes. HRM allows evaluation of swallowing function by examining dynamic and kinetic relationships between the airway (glottal closure and respiratory changes) and the entire foregut (pharynx, upper esophageal sphincter- UES, esophagus, lower esophageal sphincter- LES).Īs HRM may be complementary to VFSS, the aim of the current study was to test the main hypothesis that clinical outcomes of an integrated feeding approach (parental preference informed by VFSS and HRM testing) are superior to the standard-of-care approach (control) based on VFSS information alone. High resolution manometry (HRM) is an emerging technology in infants that permits prolonged evaluation of swallowing function without radiation exposure 12, 13, 14, 15, 16, 17, 18, 19, 20. Additionally, standardization is still being developed for infants 10, 11, and evaluation is typically limited to observation of the oral cavity and upper aerodigestive tract as well as only those swallows as captured by the radiologist. If penetration or aspiration is observed during the VFSS, feeding modifications are trialed and typically include nipple flow rate or fluid thickness changes further increasing the infant’s radiation exposure and associated risks 7, 8, 9. In infants with feeding difficulties or frequent symptoms, it is common practice to assess the infants’ eating skills via dynamic x-ray imaging or videofluoroscopy swallowing study (VFSS) to provide structural and functional insight 5, 6. Establishment of safe feeding is required prior to discharge 3, 4. Overall, prevalence of infant feeding difficulties is increased and rising in medically complex infants 1, 2. Infants with feeding difficulties can be described as having frequent aerodigestive symptoms such as coughing, apnea, bradycardia, or desaturation with oral feeding, or the inability to achieve exclusive oral feeding. Implementation of new knowledge of physiology of swallowing and airway protection may be contributory to our findings. In conclusion, an integrated approach with parent-preferred therapy based on mechanistic understanding of VFSS and HRM metrics improves oral feeding outcomes despite the evidence of penetration or aspiration. In study infants with PAS ≥ 2, motility metrics differed for increased deglutition apnea during interphase ( p = 0.02), symptoms with pharyngeal stimulation ( p = 0.02) and decreased distal esophageal contractility ( p = 0.004) with barium. Hospital-stay and growth velocity did not differ between approaches or PAS ≥ 2 (all P > 0.05). Oral feeding success was 85% in study (N = 60) vs. Basal and adaptive HRM motility characteristics were analyzed for study infants.
Clinical outcomes were oral-feeding success (primary), length of hospital stay and growth velocity. Feeding therapies were nipple flow, fluid thickness, or no modification. We hypothesized that: (a) an integrated approach (study: parent-preferred feeding therapy based on VFSS and HRM) is superior to the standard-of-care (control: provider-prescribed feeding therapy based on VFSS), and (b) motility characteristics are distinct in infants with penetration or aspiration defined as penetration-aspiration scale (PAS) score ≥ 2. Videofluoroscopy swallow studies (VFSS) and high-resolution manometry (HRM) methods complement to ascertain mechanisms of infant feeding difficulties.
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