Trial Outcomes & Findings for A Study of Neurophysiologically Based Occupational Therapy Intervention (NBOTI) for Feeding in the NCCU. (NCT NCT00766051)
NCT ID: NCT00766051
Last Updated: 2017-01-02
Results Overview
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.
COMPLETED
NA
10 participants
The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).
2017-01-02
Participant Flow
12 infants were recruited for the study. Later, matched historical controls were utilized for comparison (Nov. 2007-March 2010).
There were no group assignments. This study was quasi-experimental as matched historical controls were utilized.
Participant milestones
| Measure |
Intervention Group
This is the only intervention group that the analysis apply to.
|
Matched Historical Comparison Group
Matched Historical Controls drawn from a three year period.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Intervention Group
This is the only intervention group that the analysis apply to.
|
Matched Historical Comparison Group
Matched Historical Controls drawn from a three year period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
A Study of Neurophysiologically Based Occupational Therapy Intervention (NBOTI) for Feeding in the NCCU.
Baseline characteristics by cohort
| Measure |
Matched Historical Comparison Group
n=10 Participants
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.
|
Intervention Group
n=10 Participants
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
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.4 gestational age in weeks
STANDARD_DEVIATION 5.8 • n=5 Participants
|
32.4 gestational age in weeks
STANDARD_DEVIATION 6 • n=7 Participants
|
32.4 gestational age in weeks
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Gender
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).Population: 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.
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.
Outcome measures
| Measure |
Intervention Group
n=10 Participants
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.
|
Matched Historical Comparison Group
n=10 Participants
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).
|
|---|---|---|
|
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.
|
10.8 Days
Standard Deviation 5.6 • Interval 1.15 to 9.18
|
18.8 Days
Standard Deviation 8.2 • Interval 1.15 to 9.18
|
SECONDARY outcome
Timeframe: The time frame was from Baseline until discharge (at or before 20 days).Population: 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.
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.
Outcome measures
| Measure |
Intervention Group
n=9 Participants
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.
|
Matched Historical Comparison Group
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).
|
|---|---|---|
|
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.
Percentage of Oral Feeding
|
42.60 Percentage
Standard Deviation 33.34 • Interval 0.99 to 2.79
|
—
|
|
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.
High Frequency Percentage of Heart Rate Var. (HRV)
|
34.25 Percentage
Standard Deviation 13.96
|
—
|
SECONDARY outcome
Timeframe: Upon an infant's entry into the study, and at discharge (at or less than 20 days).Population: 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.
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.
Outcome measures
| Measure |
Intervention Group
n=9 Participants
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.
|
Matched Historical Comparison Group
n=9 Participants
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).
|
|---|---|---|
|
A Priori H3: A Total Score of the Parents' "Global Confidence" (Wolke, 1995) Was Measured on a Pre-post Test Scale.
|
1 scores on scale
Standard Deviation 5.9
|
4.56 scores on scale
Standard Deviation 4.03
|
SECONDARY outcome
Timeframe: Upon an infant's entry into the study, and again at discharge (at or less than 20 days).Population: 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.
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.
Outcome measures
| Measure |
Intervention Group
n=9 Participants
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.
|
Matched Historical Comparison Group
n=9 Participants
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).
|
|---|---|---|
|
A Priori H4: A Total Scale Score of Parents' Perception of "Infant Easiness" (Wolke, 1995) Was Measured on a Pre-post Test Scale.
|
3.89 Scores on Scale
Standard Deviation 4.4
|
6.67 Scores on Scale
Standard Deviation 4.03
|
Adverse Events
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lynne La Corte, PhD, OTR/L, OTD
University of Utah at the time of the study
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place