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The Efficacy of Occupational Therapy Intervention in the Neonatal Intensive Care Unit: An Exploratory Study
This study is ongoing, but not recruiting participants.
First Received: September 3, 2008   Last Updated: March 9, 2009   History of Changes
Sponsored by: University of Utah
Information provided by: University of Utah
ClinicalTrials.gov Identifier: NCT00766051
  Purpose

The overall research problem is that cerebral palsy and accompanying sensory neuro-impairments is a major epidemiological problem for some pre, near, and term age infants. Both infant and parent self efficacy and stress is related to the neonatal intensive care unit environment. The purpose of this study is to determine whether or not occupational therapy treatment activities for NICU infants with various diagnoses and degrees of risk for developmental delay, will affect the intervention group's oral feeding, and co-variates such as respiration and movement quality; and to determine whether or not parent efficacy can be improved and parent stress decreased. The key research question is: Can occupational therapy in the NICU promote typical infant development, and parent self efficacy? This exploratory study with 10 pre, near, and term age infants with differing diagnoses utilizes a "mixed method" design that incorporates numerical components of continuous feeding volume data, and a qualitative component of coded intervention analysis.

Additionally, data will be drawn from the chart within a three year period, for 10 historical matched controls for comparison. The investigator will use hierarchal linear modeling, correlation, and multivariate analysis to analyze the changes in the dependent variable that are predicted by the independent treatment variable. The key results will center on oral feeding, movement quality, respiration, and parent -child interactions. The data will be analyzed and the results described. The implications and recommendations for further study will be discussed in light of the best possible clinical care and programs for NICU infants. Studies of this nature inform future practice and enhance positive social change for infants at risk for cerebral palsy and or developmental delay, and for their families.


Condition
Cerebral Palsy

MedlinePlus related topics: Cerebral Palsy Paralysis
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Retrospective
Official Title: The Efficacy of Occupational Therapy Intervention in the Neonatal Intensive Care Unit: An Exploratory Study

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Will the infants in the intervention group demonstrate significant feeding efficiency on a repeated measure of daily feeding, and as compared to data from historical matched controls, as a result of the occupational therapy intervention? [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 10
Study Start Date: June 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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 (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. 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. Feeding problems are usually prevalent in infants who sustain neurological insult. The investigators will measure the intervention effects of occupational therapy upon adaptive CNS maturation using several outcome measures. If infants in the intervention group exhibit a moderate treatment effect in relationship to their feeding abilities and other covariates, perhaps the independent variable could be applied to infants with similar diagnoses in a multicenter clinically controlled randomized trial with longitudinal outcome measures to asses the efficacy of occupational therapy upon CP and/or accompanying sensory neuro-impairments.

  Eligibility

Ages Eligible for Study:   up to 3 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A mixed group of infants to include preterm to term age infants at various levels of risk (per diagnoses) for central nervous system damage and feeding problems; and some of whom may be small for dates by obstetrical dating and neurological exam. Occupational therapy intervention will begin per physician approval; when patients are medically stable, and with consistent levels of blood oxygen and stable levels of supplemental oxygen (FiO2), and who are off of medication for paralysis and weaned from sedation. Historical matched control participants will be matched with the intervention group participants who have the same diagnosis, gestational age, and neonatal complications.

Criteria

Inclusion Criteria:

  • A mixed group of infants to include preterm to term age infants at various levels of risk (per diagnoses) for central nervous system damage and feeding problems; and some of whom may be small for dates by obstetrical dating and neurological exam. Occupational therapy intervention will begin per physician approval; when patients are medically stable, and with consistent levels of blood oxygen and stable levels of supplemental oxygen (FiO2), and who are off of medication for paralysis and weaned from sedation. Historical matched control participants will be matched with the intervention group participants who have the same diagnosis, gestational age, and neonatal complications.
  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
University of Utah
Investigators
Principal Investigator: Donald .Null, M.D. University of Utah
  More Information

No publications provided

Responsible Party: Univesity of Utah / Primary Childrens Medical Center ( Donald Null M.D. )
Study ID Numbers: 23739
Study First Received: September 3, 2008
Last Updated: March 9, 2009
ClinicalTrials.gov Identifier: NCT00766051     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Occupational
Therapy
Intervention
NICU

Study placed in the following topic categories:
Paralysis
Cerebral Palsy
Brain Damage, Chronic
Central Nervous System Diseases
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 07, 2009