Trial Outcomes & Findings for Mechanisms and Management of Infant Dysphagia (NCT NCT02583360)
NCT ID: NCT02583360
Last Updated: 2021-08-23
Results Overview
The primary endpoint is the feeding success defined as full oral feeding (no tube feeds feeds) without symptoms that require interventions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
Up to 4 weeks after enrollment
Results posted on
2021-08-23
Participant Flow
Participant milestones
| Measure |
Study
Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.
Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy
|
Control
Eligible subjects who had VFSS alone with provider recommendations from the same single center.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
49
|
|
Overall Study
COMPLETED
|
60
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanisms and Management of Infant Dysphagia
Baseline characteristics by cohort
| Measure |
Study
n=60 Participants
Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.
Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy
|
Control
n=49 Participants
Eligible subjects who had VFSS alone with provider recommendations from the same single center.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
60 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
109 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
|
45.7 weeks
n=5 Participants
|
45.7 weeks
n=7 Participants
|
45.7 weeks
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
49 participants
n=7 Participants
|
109 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks after enrollmentThe primary endpoint is the feeding success defined as full oral feeding (no tube feeds feeds) without symptoms that require interventions
Outcome measures
| Measure |
Study
n=60 Participants
Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.
Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy
|
Control
n=49 Participants
Eligible subjects who had VFSS alone with provider recommendations from the same single center.
|
|---|---|---|
|
Number of Participants With Successful Safe Oral Feeding
|
51 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Unable to get growth velocity on all patients as they were not all hospitalized or weight at 4 weeks after study
The investigators will measure and track growth velocity (grams/day) during this time period. This will be completed through chart reviews of weight from subsequent clinic visits and parent interviews.
Outcome measures
| Measure |
Study
n=27 Participants
Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.
Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy
|
Control
n=46 Participants
Eligible subjects who had VFSS alone with provider recommendations from the same single center.
|
|---|---|---|
|
Weight Growth Velocity in Grams/Day
|
27 grams/day
Standard Deviation 11.1
|
26.7 grams/day
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: from hospital admission until dischargePopulation: Some patients in study group were outpatient
The investigators will track the subjects length of hospitalization which included their initial study procedure.
Outcome measures
| Measure |
Study
n=38 Participants
Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.
Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy
|
Control
n=49 Participants
Eligible subjects who had VFSS alone with provider recommendations from the same single center.
|
|---|---|---|
|
Hospital Length of Stay From Admission to Discharge in Days
|
43.6 days
Standard Deviation 49.7
|
49.9 days
Standard Deviation 58.4
|
Adverse Events
Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sudarshan Jadcherla MD
The Research Institute at Nationwide Children's Hospital
Phone: 614-355-6433
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place