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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: Completed NA study, sponsored by University of Utah.

NCT00766051 is a NA study that has completed, run by University of Utah. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

This outcome measured the number of days it took to go from all tube to all oral feeding or at discharge, whichever came first. Oral feeding percentages were based upon 150 kcal/kg/day. Feeding volumes and weights were taken directly from the nurses notes, and averaged daily. A two sample t-test was used to detect differences between the groups.

Interventions

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

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2007-11
Est. Completion 2010-03
Phase NA
University of Utah

818 total trials

What the finished NCT00766051 record still lists

NCT00766051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00766051's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00766051, the US trial registry maintained by the National Library of Medicine. NCT00766051 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.