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NCT00766051 · ClinicalTrials.gov registry record · NA
A Study of Neurophysiologically Based Occupational Therapy Intervention (NBOTI) for Feeding in the NCCU.
A NA study, sponsored by University of Utah.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT00766051 is a NA study that has completed, run by University of Utah. The registered enrollment target is 10 participants.
The verdict
NCT00766051, a NA study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- OTHER The intervention group: Neurophysiologically Based Occupational Therapy Intervention (NBOTI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2007-11 |
| Est. Completion | 2010-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00766051
The ClinicalTrials.gov registry entry for NCT00766051 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which The intervention group: Neurophysiologically Based Occupational Therapy Intervention (NBOTI) is the first listed.
NCT00766051 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00766051 about?
NCT00766051 is a clinical study titled "A Study of Neurophysiologically Based Occupational Therapy Intervention (NBOTI) for Feeding in the NCCU.". 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 woul...
What is the current status of trial NCT00766051?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2007-11. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00766051?
The interventions under investigation include: The intervention group: Neurophysiologically Based Occupational Therapy Intervention (NBOTI) (OTHER).
Who is sponsoring clinical trial NCT00766051?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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