Trial Outcomes & Findings for D-cycloserine and Treatment of Feeding Disorders (NCT NCT01923896)

Results Overview

Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ''show me''; gestural: ''show me like this'' plus modeling opening the mouth; physical: ''show me'' plus gentle pressure applied to the side of the teeth with a baby spoon).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Mealtime behavior (swallowing) at meal 1

Results posted on

2014-10-23

Participant Flow

Participants were enrolled beginning in April 2013 through July 2013

Participant milestones

Participant milestones
Measure	Behavioral Intervention & DCS Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.	Behavioral Intervention & Placebo Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Overall Study STARTED	8	8
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Behavioral Intervention & DCS Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.	Behavioral Intervention & Placebo Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Overall Study Adverse Event	1	0

Baseline Characteristics

D-cycloserine and Treatment of Feeding Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Intervention & DCS n=8 Participants Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.	Behavioral Intervention & Placebo n=8 Participants Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.	Total n=16 Participants Total of all reporting groups
Age, Continuous	33.9 Months STANDARD_DEVIATION 10.1 • n=5 Participants	32.3 Months STANDARD_DEVIATION 11.9 • n=7 Participants	33.1 Months STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Mealtime behavior (swallowing) at meal 1

Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ''show me''; gestural: ''show me like this'' plus modeling opening the mouth; physical: ''show me'' plus gentle pressure applied to the side of the teeth with a baby spoon).

Outcome measures

Outcome measures
Measure	Behavioral Intervention & DCS n=8 Participants Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.	Behavioral Intervention & Placebo n=8 Participants Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Rapid Swallowing	18.6 percentage of bites Interval 13.0 to 30.0	14.3 percentage of bites Interval 8.0 to 58.8

PRIMARY outcome

Timeframe: Mealtime behavior (swallowing) at meal 13

Population: All subjects completed up to meal 13.

Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ''show me''; gestural: ''show me like this'' plus modeling opening the mouth; physical: ''show me'' plus gentle pressure applied to the side of the teeth with a baby spoon).

Outcome measures

Outcome measures
Measure	Behavioral Intervention & DCS n=8 Participants Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.	Behavioral Intervention & Placebo n=8 Participants Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Rapid Swallowing	96.3 percentage of bites Interval 82.3 to 100.0	88.3 percentage of bites Interval 10.0 to 100.0

PRIMARY outcome

Timeframe: Mealtime behavior (disruptions) at meal 1

Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder's hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal

Outcome measures

Outcome measures
Measure	Behavioral Intervention & DCS n=8 Participants Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.	Behavioral Intervention & Placebo n=8 Participants Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Disruptions	87.6 percentage of inappropriate behaviors Interval 75.7 to 98.8	84.3 percentage of inappropriate behaviors Interval 35.4 to 98.6

PRIMARY outcome

Timeframe: Mealtime behavior (disruptions) at meal 13

Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder's hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal

Outcome measures

Outcome measures
Measure	Behavioral Intervention & DCS n=8 Participants Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.	Behavioral Intervention & Placebo n=8 Participants Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Disruptions	13.4 percentage of inappropriate behaviors Interval 0.0 to 40.0	15 percentage of inappropriate behaviors Interval 1.4 to 48.9

Adverse Events

Behavioral Intervention & DCS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Behavioral Intervention & Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Behavioral Intervention & DCS n=8 participants at risk Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.	Behavioral Intervention & Placebo n=8 participants at risk Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Gastrointestinal disorders Diarrhea	12.5% 1/8 • Number of events 1	0.00% 0/8

Additional Information

William G. Sharp Ph.D.

Emory University

Phone: 404-419-5162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place