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

Purpose

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.

Condition	Intervention
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)


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Efficacy of Neurophysiologically Based Occupational Therapy Intervention in the Neonatal Intensive Care Unit: An Exploratory Study

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Cerebral Palsy

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

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). ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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). ] [ Designated as safety issue: No ]
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). ] [ Designated as safety issue: No ]
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). ] [ Designated as safety issue: No ]
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.


Enrollment:	10
Study Start Date:	November 2007
Study Completion Date:	March 2010
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Show Detailed Description

Eligibility


Ages Eligible for Study:	29 Weeks to 44 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A mixed group of infants included preterm to term age infants at various levels of risk (per diagnoses) for central nervous system damage and feeding problems; but not small for dates by obstetrical dating and neurological exam, or genetic anomaly. Occupational therapy intervention began per physician approval; when patients were medically stable, and with consistent levels of blood oxygen and stable levels of supplemental oxygen (FiO2), and who were off of medication for paralysis and weaned from sedation. Historical matched control participants were matched with the intervention group participants who have the same diagnosis, gestational age, and neonatal complications.

Exclusion criteria included infants with specific cardiac distress syndrome, genetic anomalies, and small for dates.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766051

Locations


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

Sponsors and Collaborators

Lynne La Corte

Walden University

Primary Children's Hospital

Mesa State College: Grand Junction, Colorado

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

Investigators


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

More Information

No publications provided


Responsible Party:	Lynne La Corte, study director, University of Utah
ClinicalTrials.gov Identifier:	NCT00766051 History of Changes
Other Study ID Numbers:	23739
Study First Received:	September 3, 2008
Results First Received:	April 4, 2011
Last Updated:	September 9, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:


Neurophysiologically Based Occupational Therapy Intervention (NBOTI) NBOTI NICU NCCU Developmental Biology	Critical Period Brain Development Sensory Integration Neurodevelopment Sensitive Period

Additional relevant MeSH terms:


Motor Skills Disorders Mental Disorders Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on March 03, 2015