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

NCT00766051 | Completed Results

• 1 other identifier: 23739
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cerebral Palsy; Sensorimotor Deficits; Sensory Processing Disorder; Feeding Problems; Developmental Coordination Disorder; Picky Eaters; NICU

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).

Secondary Outcomes (3)

• 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.

  The time frame was from Baseline until discharge (at or before 20 days).

• A Priori H3: A Total Score of the Parents' "Global Confidence" (Wolke, 1995) Was Measured on a Pre-post Test Scale.

  Upon an infant's entry into the study, and at discharge (at or less than 20 days).

• A Priori H4: A Total Scale Score of Parents' Perception of "Infant Easiness" (Wolke, 1995) Was Measured on a Pre-post Test Scale.

  Upon an infant's entry into the study, and again at discharge (at or less than 20 days).

Study Arms (2)

Intervention Group

EXPERIMENTAL

The infants in the intervention group were problem eaters with various diagnosis

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

Matched Historical Comparison Group

NO INTERVENTION

The matched historical comparison group were also problem eaters and these infants did not receive the neurophysiologically based occupational therapy Intervention.

Interventions

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

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.

Intervention Group

Eligibility Criteria

• Age: 29 Weeks - 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Walden University: collaborator
• Primary Children's Hospital: collaborator
• Mesa State College: Grand Junction, Colorado: collaborator
• Politecnico di Milano: P.zza Leonardo da Vinci, 32, 20133 Milano, Italy: collaborator

Study Sites (2)

University of Utah / Primary Childrens Medical Center

Salt Lake City, Utah, 84132, United States

Location

Univesity of Utah / Primary Childrens Medical Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• La Corte, L.F. (2010). The efficacy of neurophysiologically based occupational therapy intervention in the neonatal intensive care unit: An exploratory study. ProQuest/UMI Dissertation Publishing, no. 3408874. All other citations can be found in the above reference.

  RESULT

MeSH Terms

Conditions

Cerebral Palsy; Motor Skills Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

The limitation of this study is that the effectiveness of the neurophysiologically based occupational therapy intervention applies to the diagnostic groups of the infants that participated in this study.

Results Point of Contact

• Title: Lynne La Corte, PhD, OTR/L, OTD
• Organization: University of Utah at the time of the study

lflacorte@independence.net

970 4330981

Study Officials

• Donald Null, Jr., M.D.

  University of Utah, Medical Director NCCU, Primary Children's Medical Center

  PRINCIPAL INVESTIGATOR

• Lynne F. La Corte, Ph.D, OTR/L, OTD

  University of Utah, Division of Occupational Therapy

  STUDY DIRECTOR

• Tracy Karp, RNC, MS, NNP

  Primary Children's Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: October 3, 2008
• Study Start: November 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: March 1, 2010
• Last Updated: January 2, 2017
• Results First Posted: September 11, 2012

Record last verified: 2016-11

Locations

US (2)