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Patterned feeding experience for preterm infants: study protocol for a randomized controlled trial
Rita H Pickler1, Paul A Wetzel2, Jareen Meinzen-Derr3
1Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA. Rita.pickler@cchmc.org.
Insights
A patterned feeding experience may improve neurobehavioral organization and cognitive function in preterm infants. This intervention aims to enhance neural connections during critical developmental periods for better long-term outcomes.
Area of Science:
- Neonatal Development
- Neuroscience
- Developmental Pediatrics
Background:
- Preterm infants, especially those with very low birth weight, face high risks of neurobehavioral disabilities, including cognitive, behavioral, and social delays.
- Hospitalization in the neonatal intensive care unit (NICU) and inconsistent caregiving are linked to poor neurobehavioral outcomes.
- Neuroprotective strategies during sensitive periods of neural plasticity can mitigate brain damage progression.
Purpose of the Study:
- To evaluate the impact of a patterned feeding experience on the neurobehavioral organization and development of preterm infants.
- To assess the intervention's effects on cognitive function and clinical outcomes in this vulnerable population.
- To explore the potential of early-life interventions to improve long-term neurodevelopmental trajectories.
Main Methods:
- A randomized trial involving 120 preterm infants, comparing a patterned feeding experience group with a usual care control group.
- The intervention provided tactile feeding experiences from gavage feeding initiation to NICU discharge.
- Primary outcomes included neurobehavioral organization (assessed at multiple time points), with secondary outcomes encompassing cognitive function, feeding development, and clinical measures.
Main Results:
- The study is designed to measure the effects of the intervention on neurobehavioral organization, cognitive function, and clinical outcomes.
- Analysis will consider the influence of demographic and biobehavioral factors on the observed outcomes.
- Specific results regarding the intervention's efficacy are pending the trial's completion and data analysis.
Conclusions:
- The patterned feeding intervention, delivered during a critical neurodevelopmental window, is hypothesized to strengthen neural connections.
- This may lead to improvements in language, cognitive skills, and overall neurobehavioral organization.
- The study aims to provide evidence for a novel, non-pharmacological approach to enhance preterm infant development.
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.
Discussion:
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.
Trial Registration:
NCT01577615 11 April 2012.
