A Study of Neurophysiologically Based Occupational Therapy Intervention (NBOTI) for Feeding in the NCCU.

NCT00766051 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-01-02

Study results available
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Summary

Many critically ill newborns in the neonatal intensive care (NICU) or critical care unit (NCCU) environment develop feeding and movement problems. The purpose of this study was to determine the extent to which neurophysiologically based occupational therapy intervention (NBOTI) for NCCU infants would affect the intervention group's oral feeding and other covariates, such as heart rate variability (HRV) during feeding. The biopsychosocial model provided the study's conceptual framework. The key research question explored whether NBOTI in the NCCU promoted healthy infant development through feeding, movement organization, and parent self-efficacy. This exploratory study with 10 NCCU infants and 10 historical matched controls utilized a mixed method design of qualitatively coded video analysis and inferential statistics such as the t test, the binomial test, hierarchal linear modeling (HLM), and multivariate analysis. Significant differences were obtained between the intervention and comparison groups in the number of days from all tube to all oral feeding before discharge and speed at which the infants gained weight. Longitudinal analyses of the intervention group data were employed to reveal significant trends and pre/post differences in the HRV data along with how quickly the infants ate, parent perceptions of self efficacy and decreased stress in the NCCU. Finally, qualitative findings obtained from videotape analysis provide further evidence that NBOTI was effective in facilitating feeding and promoting development. The recommendations are to replicate this study to validate and expand the findings of the current study. The model for infant care suggested by the findings could contribute to positive social change by fostering positive physical and emotional child development and healthy child-parent and family-caregiver relationships.

Conditions

  • Cerebral Palsy
  • Sensorimotor Deficits
  • Sensory Processing Disorder
  • Feeding Problems
  • Developmental Coordination Disorder
  • Picky Eaters
  • NICU

Interventions

OTHER

The intervention group: Neurophysiologically Based Occupational Therapy Intervention (NBOTI)

This study included a pre-feeding, feeding, and postural-respiratory protocol, given per the attending physician's order. The interventions were given daily when possible, and the infants FiO2 and heart rate, along with stress behaviors, were monitored prior to, during, and after the NBOTI. The intervention included parent education for feeding, handling, and interaction with their infant, along with nursing training during the feeding session. The occupational therapy investigator partnered with the parents and when the parents were not available, she partnered with the nursing staff.

Sponsors & Collaborators

  • Walden University

    collaborator OTHER
  • Primary Children's Hospital

    collaborator OTHER
  • Mesa State College: Grand Junction, Colorado

    collaborator UNKNOWN
  • Politecnico di Milano: P.zza Leonardo da Vinci, 32, 20133 Milano, Italy

    collaborator UNKNOWN
  • University of Utah

    lead OTHER

Principal Investigators

  • Donald Null, Jr., M.D. · University of Utah, Medical Director NCCU, Primary Children's Medical Center

  • Lynne F. La Corte, Ph.D, OTR/L, OTD · University of Utah, Division of Occupational Therapy

  • Tracy Karp, RNC, MS, NNP · Primary Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
29 Weeks
Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-06-30
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00766051 on ClinicalTrials.gov