Clinical trial NCT00766051: A Study of Neurophysiologically Based Occupational Therapy Intervention (NBOTI) for Feeding in the NCCU.
Official title: The Efficacy of Neurophysiologically Based Occupational Therapy Intervention in the Neonatal Intensive Care Unit: An Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Walden University
name: Primary Children's Hospital
name: Mesa State College: Grand Junction, Colorado
name: Politecnico di Milano: P.zza Leonardo da Vinci, 32, 20133 Milano, Italy
First posted: 2008-10-03
Enrollment: 10
Sex: ALL
Minimum age (years): 29
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Cerebral palsy (CP) is the most common physical disability in childhood (Surveillance of Cerebral Palsy in Europe \[SCPE\], 2000, 2002; Winter, Autry, Boyle, \& Yeargin-Allsopp, 2002),and epidemiological studies of industrialized countries indicate that CP occurs in 2.0 to 2.5 per 1000 live births (Hagberg, Hagberg, Beckung, \& Uvebrant, 2001; Paneth \& Kiely, 1984; Parkes, Dolk, Hill, \& Pattenden, 2001). CP is defined as a movement impairment ranging from mild to severe (Bax et al., 2005; Bobath, 1954; Nelson, 2001); and occurs through social, physical and environmental causal pathways that result in a brain lesion sometime during the ante, peri or post natal period of birth (Stanley, Blair, \& Alberman, 2000).

Preterm birth accounts for 40% of all cases of cerebral palsy (Stanley et al., 2000). An infant is born preterm if the birth occurs between 17-36 weeks from their date of conception. Per 1,000 births in the United States between 1989 and 1996, the rate of preterm births increased by 4%, with African American preterm births nearly twice that of whites (Morbidity and Mortality Weekly Report \[MMWR\], 1999). The rate of preterm birth in the United States is about 10% of all births. Early born preterm infants need organ support in neonatal intensive care unit (NICU) nurseries. Problems encountered by this population due to their undeveloped systems consist of respiratory, cardiac, central nervous system (CNS) vulnerability for damage, feeding and gastrointestinal, and kidney problems (Goldenring, 2004). Very and extremely preterm infants (less than 32 weeks) have the highest rate of developmental disability. Norm referenced cognitive, social, and neuro-developmental test scores at 6 years of age indicated that 80% of extremely preterm infants exhibited mild, moderate, and severe sensorimotor (perceptual-cognitive-motor) disability; with 12% of these infants diagnosed with disabling CP (Marlow, Wolke, Bracewell, \& Samara, 2005). Rose, Feldman, \& Jankowski, (2002) found that very preterm children needed 30% more time to process visual and somatosensory perceptual information needed for intellectual tasks at 5, 7, and 12 months of age. These discrepancies in efficient processing of sensorimotor stimulation continue into childhood (DeMaio-Feldman, 1994; Feder, et al. 2005) as measured from a child's cognitive responses to their environment (Barlow \& Lewandowski, 2000), and internally from mechanisms that provide a foundation for equilibrium and perception such as information generated from within joints, muscles, and skin as tactile-kinesthetic information (Bracewell \& Marlow,2002; de Groot, van Hoek, Hopkins, \& Touwen, 1993), and as auditory, vestibular, and visual postural-spatial processing (de Graaf, Samsom, Pettersen, Schaaf, van Schie, \& de Groot, 2004; De Vries, \& De Groot, 2002). In addition to factors such as low birth weight that predispose infants to central nervous system insult (40%), the remaining 60% of infants who are diagnosed with CP suffer from acute insult to the CNS (hemorrhage, increased intracranial pressure, or hypoxic ischemic injury) for other reasons, such as respiratory disease, sepsis, and necrotizing enterocolitis in neonates (NEC). Many different factors, endogenous mediators and mechanisms, and mechanical, can alter vascular pressure. One respiratory condition in pre, near, and at term age infants that results in a composite of neuro-developmental and audiologic impairment (motor, cognitive, perceptual, and behavioral), ranging from between 15-50%, is persistent pulmonary hypertension in the newborn (PPHN) (Lipkin, Davidson, Rhines, \& Chang, 2002; Lipkin, Davidson, Rhines, \& Chang, 2002). As a respiratory disease process, PPHN can result from pulmonary hypoplasia associated with diaphragmatic, and to a lesser degree abdominal wall hernias, or from vasoconstriction associated with bacterial sepsis, in addition to other pathophysiology (Hagedorn, Gardner, Dickey, \& Abman, 2006). This exploratory within group study focuses upon pre, near, and term age infants with differing diagnoses and varying degrees of risk for a diagnoses of CP, developmental coordination disorder, or sensory processing difficulties. Feeding problems are usually prevalent in infants who sustain neurological insult in addition to near term or term age infants with serious developmental disruptions. The investigators measured the intervention effects of neurophysiologically based occupational therapy upon adaptive CNS maturation using several outcome measures. Since infants in the intervention group exhibited a large treatment effect in relationship to their feeding abilities and other covariates, this study should be replicated with infants with similar diagnoses with the same longitudinal outcome measures to learn more about and to further validate the efficacy of neurophysiologically based occupational therapy upon feeding, infant sensorimotor development, and parent efficacy in the NICU.

The following collaborators assisted on this research project:

Walden University: Minneapolis, Minnesota - Ray Thron, PhD, Lela Llorens, Ph.D, OTR, FAOTA, Chester Jones, Ph.D, and Aqueil Ahmad, Ph.D

Primary Children's Medical Center: Salt Lake City, Utah - Mr. Ramsey Worman, Department of Bioengineering, David Bradley, MD and Ms. Barbara Wright, Department of Cardiology, and Mr. Doug Wolfe, Systems Administrator

Mesa State College: Grand Junction, Colorado - Richard Ott, Ph.D, Computer Science, Mathematics, \& Statistics

Politecnico di Milano: P.zza Leonardo da Vinci, 32, 20133 Milano, Italy - Manuela Farrario, Ph.D, and Sergio Cerutti, Ph.D. Department of Bioingeneering

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).
Secondary outcomes:
measure: 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.
timeFrame: The time frame was from Baseline until discharge (at or before 20 days).
measure: A Priori H3: A Total Score of the Parents' "Global Confidence" (Wolke, 1995) Was Measured on a Pre-post Test Scale.
timeFrame: Upon an infant's entry into the study, and at discharge (at or less than 20 days).
measure: A Priori H4: A Total Scale Score of Parents' Perception of "Infant Easiness" (Wolke, 1995) Was Measured on a Pre-post Test Scale.
timeFrame: Upon an infant's entry into the study, and again at discharge (at or less than 20 days).
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah / Primary Childrens Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: Univesity of Utah / Primary Childrens Medical Center
state: Utah
Study officials:
affiliation: University of Utah, Medical Director NCCU, Primary Children's Medical Center
name: Donald Null, Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah, Division of Occupational Therapy
name: Lynne F. La Corte, Ph.D, OTR/L, OTD
role: STUDY_DIRECTOR
affiliation: Primary Children's Hospital
name: Tracy Karp, RNC, MS, NNP
role: STUDY_CHAIR
References:
citation: 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.