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Trial record 25 of 27 for:    "Developmental Dyspraxia"

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

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ClinicalTrials.gov Identifier: NCT00766051
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : September 11, 2012
Last Update Posted : January 2, 2017
Sponsor:
Collaborators:
Walden University
Primary Children's Hospital
Mesa State College: Grand Junction, Colorado
Politecnico di Milano: P.zza Leonardo da Vinci, 32, 20133 Milano, Italy
Information provided by (Responsible Party):
University of Utah

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cerebral Palsy
Sensorimotor Deficits
Sensory Processing Disorder
Feeding Problems
Developmental Coordination Disorder
Picky Eaters
NICU
Intervention Other: The intervention group: Neurophysiologically Based Occupational Therapy Intervention (NBOTI)
Enrollment 10
Recruitment Details 12 infants were recruited for the study. Later, matched historical controls were utilized for comparison (Nov. 2007-March 2010).
Pre-assignment Details There were no group assignments. This study was quasi-experimental as matched historical controls were utilized.
Arm/Group Title Intervention Group Matched Historical Comparison Group
Hide Arm/Group Description This is the only intervention group that the analysis apply to. Matched Historical Controls drawn from a three year period.
Period Title: Overall Study
Started 12 10
Completed 10 10
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Matched Historical Comparison Group Intervention Group Total
Hide Arm/Group Description This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee (1978) and consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia. This is the only Matched Historical Comparison group infants that the analysis refer to. The intervention group consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
10
 100.0%
10
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Gestational age in weeks
Number Analyzed 10 participants 10 participants 20 participants
34.4  (5.8) 32.4  (6) 32.4  (5.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
5
  50.0%
4
  40.0%
9
  45.0%
Male
5
  50.0%
6
  60.0%
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).
Hide Outcome Measure Data
Hide Analysis Population Description
The intervention group and matched historical comparison group consisted of Four pairs of Extremely Preterm to Preterm infants with high risk factors, Three pairs of term or near term infants with Gastroschisis, Two pairs of infants term or near term with Omphalocele, and One pair of infants term age with Congenital Diaphragmatic Hernia.
Arm/Group Title Intervention Group Matched Historical Comparison Group
Hide Arm/Group Description:
This is the only intervention group that the analysis apply to. The intervention and the matched historical comparison group consisted of preterm, near term and full term infants with feeding problems.
This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee, (1978).
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Days
10.8  (5.6) 18.8  (8.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Matched Historical Comparison Group
Comments The expected outcome was that infants in the intervention group would exhibit significantly less number of days to attain oral feeding.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments The P value is not adjusted for multiple comparisons or for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8
Confidence Interval (2-Sided) 95%
5 to 11
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.76
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame The time frame was from Baseline until discharge (at or before 20 days).
Hide Outcome Measure Data
Hide Analysis Population Description
The intervention group consisted of Four Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, and Two near term infants with Omphalocele. This outcome measured the correlation between the percentage of oral feedings and the percentage of High Frequesncy Heart Rate Variability.
Arm/Group Title Intervention Group
Hide Arm/Group Description:
This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: Percentage
Percentage of Oral Feeding 42.60  (33.34)
High Frequency Percentage of Heart Rate Var. (HRV) 34.25  (13.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group
Comments Pearson Correlation, 2-tailed
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments This correlation is between the intervention groups' initial level of relaxation and final level of relaxation during the oral feeding period.
Method of Estimation Estimation Parameter Slope
Estimated Value 0.275
Estimation Comments [Not Specified]
3.Secondary Outcome
Title A Priori H3: A Total Score of the Parents' "Global Confidence" (Wolke, 1995) Was Measured on a Pre-post Test Scale.
Hide Description 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.
Time Frame Upon an infant's entry into the study, and at discharge (at or less than 20 days).
Hide Outcome Measure Data
Hide Analysis Population Description
The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.
Arm/Group Title Intervention Group Pre-test Intervention Group Post Test
Hide Arm/Group Description:
This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
This is the only intervention group that the analysis apply to.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: scores on scale
1  (5.9) 4.56  (4.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group Pre-test, Intervention Group Post Test
Comments Parent pre-post one sided t test of parents' "global confidence", measured parental confidence in feeding, handling, and interacting with their infant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < .02
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.6
Confidence Interval (1-Sided) 95%
6.7
Parameter Dispersion
Type: Standard Deviation
Value: 5.2
Estimation Comments An increase in this test scale score means more parent confidence.
4.Secondary Outcome
Title A Priori H4: A Total Scale Score of Parents' Perception of "Infant Easiness" (Wolke, 1995) Was Measured on a Pre-post Test Scale.
Hide Description 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.
Time Frame Upon an infant's entry into the study, and again at discharge (at or less than 20 days).
Hide Outcome Measure Data
Hide Analysis Population Description
The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.
Arm/Group Title Intervention Group Pre-test Intervention Group Post Test
Hide Arm/Group Description:
This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
This is the only intervention group that the analysis apply to.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: Scores on Scale
3.89  (4.4) 6.67  (4.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group Pre-test, Intervention Group Post Test
Comments Parent pre-post one sided t test on the Easiness Scale of the Mother and Baby Scales in how parents percieve their interactions (alert-responsiveness, mood) with their infant and infant sleep patterns .
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < .03
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.8
Confidence Interval (1-Sided) 95%
4.54
Parameter Dispersion
Type: Standard Deviation
Value: 4.3
Estimation Comments An increase in this test scale score means an increase in the parents' perception of their infants' easiness during caregiving.
Time Frame [Not Specified]
Adverse Event Reporting Description Other adverse events were not collected.
 
Arm/Group Title Intervention Group
Hide Arm/Group Description This is the only intervention group that the analysis apply to.
All-Cause Mortality
Intervention Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Group
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group
Affected / at Risk (%)
Total   0/0 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lynne La Corte, PhD, OTR/L, OTD
Organization: University of Utah at the time of the study
Phone: 970 4330981
Publications of Results:
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.
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00766051     History of Changes
Other Study ID Numbers: 23739
First Submitted: September 3, 2008
First Posted: October 3, 2008
Results First Submitted: April 4, 2011
Results First Posted: September 11, 2012
Last Update Posted: January 2, 2017