Trial record 4 of 14 for:    Developmental Dyspraxia

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

This study has been completed.
Sponsor:
Collaborators:
Walden University
Primary Children's Medical Center: Salt Lake City, Utah
Mesa State College: Grand Junction, Colorado
Politecnico di Milano: P.zza Leonardo da Vinci, 32, 20133 Milano, Italy
Information provided by (Responsible Party):
Lynne La Corte, University of Utah
ClinicalTrials.gov Identifier:
NCT00766051
First received: September 3, 2008
Last updated: September 9, 2012
Last verified: September 2012
  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:


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.

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

Locations
United States, Utah
Univesity of Utah / Primary Childrens Medical Center
Salt Lake City, Utah, United States, 84132
University of Utah / Primary Childrens Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Lynne La Corte
Walden University
Primary Children's Medical Center: Salt Lake City, Utah
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 Medical Center
  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:
Cerebral Palsy
Motor Skills Disorders
Ataxia
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014