A Study of Neurophysiologically Based Occupational Therapy Intervention (NBOTI) for Feeding in the NCCU. (NBOTI)
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|ClinicalTrials.gov Identifier: NCT00766051|
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : September 11, 2012
Last Update Posted : January 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy Sensorimotor Deficits Sensory Processing Disorder Feeding Problems Developmental Coordination Disorder Picky Eaters NICU||Other: The intervention group: Neurophysiologically Based Occupational Therapy Intervention (NBOTI)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Neurophysiologically Based Occupational Therapy Intervention in the Neonatal Intensive Care Unit: An Exploratory Study|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||March 2010|
Experimental: Intervention Group
The infants in the intervention group were problem eaters with various diagnosis
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.
No Intervention: Matched Historical Comparison Group
The matched historical comparison group were also problem eaters and these infants did not receive the neurophysiologically based occupational therapy Intervention.
- A Priori H1. The Number of Days to Achieve Oral Feeding Between the Intervention Group and the Matched Historical Comparison Group - From All Tube to All Oral Feeding - Was Analyzed. [ Time Frame: The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days). ]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.
- A Priori H2: The Increase in Oral Feeding Percentage Over Days Was Correlated With Increasing Respiratory Competency During Oral Feeding; Measured as the High Frequency Percentage (HF%) of Intervention Groups' Heart Rate Variability (HRV) During Feeding. [ Time Frame: The time frame was from Baseline until discharge (at or before 20 days). ]Oral feeding percentage was based upon 150 kc/kg/day. Heart rate data was recorded about once per week during feeding using a Holter monitor connected to the bedside ecg. This data was downloaded in Cardiology, converted to numerical data as HRV by bioengineers at Politecnico di Milano, Italy. As infants reached 100% of oral feedings, heart rate variability data was analyzed to determine the infants' overall trend toward relaxation, measured as increasing High Frequency Percentage (HF %). Hierarchical linear modeling (HLM) (Singer and Willett, 2003) SPSS Grad Pack 17, mixed model analysis.
- A Priori H3: A Total Score of the Parents' "Global Confidence" (Wolke, 1995) Was Measured on a Pre-post Test Scale. [ Time Frame: Upon an infant's entry into the study, and at discharge (at or less than 20 days). ]The Global Confidence Scale of The Mother and Baby Scales (Wolke [in Brazelton and Nugent], 1995]) is a total score measure of mother/parent self efficacy in the NICU as a result of training in NBOTI. It is a total score measure of the parent's perceived efficacy of themselves as confidence in the feeding, handling, caretaking, and interactions needed to foster relationships with their infants. An increase in this score denotes an increase in the parent's perception of their global confidence in caring for their infant. Global Confidence Measure uses a Likert scale. There are three questions, ranging from -3-3. The maximum score is 9, and the minimum score is -9.
- A Priori H4: A Total Scale Score of Parents' Perception of "Infant Easiness" (Wolke, 1995) Was Measured on a Pre-post Test Scale. [ Time Frame: Upon an infant's entry into the study, and again at discharge (at or less than 20 days). ]The Easiness Scale measures the parent's perceived efficacy in the areas of infant irritability, sleeping habits, alertness and responsiveness, and difficulty. The Easiness Scale(Wolke [in Brazelton and Nugent], 1995]) was used to determine mother/parent perceptions of their infants' mood and state in the NICU as a result of training in NBOTI. An increasing score denotes an improvement in parent efficacy in their perception of their infant's easiness.uses a Likert scale. There are four questions, ranging from -3-3. The maximum score is 12, and the minimum score is -12.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766051
|United States, Utah|
|University of Utah / Primary Childrens Medical Center|
|Salt Lake City, Utah, United States, 84132|
|Univesity of Utah / Primary Childrens Medical Center|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Donald Null, Jr., M.D.||University of Utah, Medical Director NCCU, Primary Children's Medical Center|
|Study Director:||Lynne F. La Corte, Ph.D, OTR/L, OTD||University of Utah, Division of Occupational Therapy|
|Study Chair:||Tracy Karp, RNC, MS, NNP||Primary Children's Hospital|