title: Patterned feeding experience for preterm infants: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Neurobehavioral disabilities occur in 5-15% of preterm infants with an estimated 50-70% of very low birth weight preterm infants experiencing later dysfunction, including cognitive, behavioral, and social delays that often persist into adulthood. Factors implicated in poor neurobehavioral and developmental outcomes are hospitalization in the neonatal intensive care unit (NICU) and inconsistent caregiving patterns. Although much underlying brain damage occurs in utero or shortly after birth, neuroprotective strategies can stop lesions from progressing, particularly when these strategies are used during the most sensitive periods of neural plasticity occurring months before term age. The purpose of this randomized trial is to test the effect of a patterned feeding experience on preterm infants' neurobehavioral organization and development, cognitive function, and clinical outcomes.
  
  
  METHODS
  This trial uses an experimental, longitudinal, 2-group design with 120 preterm infants. Infants are enrolled within the first week of life and randomized to an experimental group receiving a patterned feeding experience from the first gavage feeding through discharge or to a control group receiving usual feeding care experience. The intervention involves a continuity of tactile experiences associated with feeding to train and build neuronal networks supportive of normal infant feeding experience. Primary outcomes are neurobehavioral organization as measured by Neurobehavioral Assessment of the Preterm Infant at 3 time points: the transition to oral feedings, NICU discharge, and 2 months corrected age. Secondary aims are cognitive function measured using the Bayley Scales of Infant and Toddler Development, Third Edition at 6 months corrected age, neurobehavioral development (sucking organization, feeding performance, and heart rate variability), and clinical outcomes (length of NICU stay and time to full oral feeding). The potential effects of demographic and biobehavioral factors (perinatal events and conditions of maternal or fetal/newborn origin and immunologic and genetic biomarkers) on the outcome variables will also be considered.
  
  
  CONCLUSIONS
  Theoretically, the intervention provided at a critical time in neurologic system development and associated with a recurring event (feeding) should enhance neural connections that may be important for later development, particularly language and other cognitive and neurobehavioral organization skills.
  
  
  BACKGROUND
  NCT01577615 11 April 2012.
authors.affiliation: Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA. Rita.pickler@cchmc.org.
authors.forename: Rita H
authors.initials: RH
authors.lastname: Pickler
authors.affiliation: Virginia Commonwealth University, 401 West Main Street, PO Box 843067, Richmond, VA, USA. pawetzel@vcu.edu.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Wetzel
authors.affiliation: Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA. Jareen.meinzen_derr@cchmc.org.
authors.forename: Jareen
authors.initials: J
authors.lastname: Meinzen-Derr
authors.affiliation: Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA. Heather.tubbs_cooley@cchmc.org.
authors.forename: Heather L
authors.initials: HL
authors.lastname: Tubbs-Cooley
authors.affiliation: Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA. Margo.moore@cchmc.org.
authors.forename: Margo
authors.initials: M
authors.lastname: Moore
mesh_terms: D000367:Age Factors; D001903:Bottle Feeding; D001942:Breast Feeding; D002657:Child Development; D002985:Clinical Protocols; D003071:Cognition; D004750:Enteral Nutrition; D005247:Feeding Behavior; D005248:Feeding Methods; D005260:Female; D005865:Gestational Age; D006339:Heart Rate; D006801:Humans; D007223:Infant; D018730:Infant Behavior; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D007902:Length of Stay; D008137:Longitudinal Studies; D008297:Male; D009420:Nervous System / Q000254:growth & development*; D009434:Neural Pathways / Q000503:physiopathology; D009820:Ohio; D012107:Research Design; D013391:Sucking Behavior; D013997:Time Factors; D014110:Touch; D016896:Treatment Outcome