Trial Outcomes & Findings for Prophylactic Phenobarbital After Neonatal Seizures (NCT NCT01089504)
NCT ID: NCT01089504
Last Updated: 2016-02-03
Results Overview
The Bayley Scales of Infant Development (BSID) measure the mental and motor development and test the behavior of infants from one to 42 months of age. The test is intended to measure a child's level of development in three domains: cognitive, motor, and behavioral. The primary outcome is the Bayley assessment of development at 2 years of age. This is a standardized developmental exam that is normalized to the age of the child in months. The mean adjusted score is 100 with a standard deviation of 15 (higher being better) - very similar to the more familiar IQ score.
TERMINATED
PHASE4
13 participants
18-22 months
2016-02-03
Participant Flow
Participant milestones
| Measure |
Phenobarbital
Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months
|
Placebo
Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Phenobarbital
Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months
|
Placebo
Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Prophylactic Phenobarbital After Neonatal Seizures
Baseline characteristics by cohort
| Measure |
Phenobarbital
n=8 Participants
Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months
|
Placebo
n=5 Participants
Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
5 participants
n=107 Participants
|
13 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 18-22 monthsPopulation: Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.
The Bayley Scales of Infant Development (BSID) measure the mental and motor development and test the behavior of infants from one to 42 months of age. The test is intended to measure a child's level of development in three domains: cognitive, motor, and behavioral. The primary outcome is the Bayley assessment of development at 2 years of age. This is a standardized developmental exam that is normalized to the age of the child in months. The mean adjusted score is 100 with a standard deviation of 15 (higher being better) - very similar to the more familiar IQ score.
Outcome measures
| Measure |
Phenobarbital
n=8 Participants
Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months
|
Placebo
n=5 Participants
Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months
|
|---|---|---|
|
Mean Bayley Scales of Infant Development (BSID) Score - Cognitive
|
87.50 units on a scale
Standard Deviation 11.90
|
92.50 units on a scale
Standard Deviation 26.61
|
SECONDARY outcome
Timeframe: 18-22 monthsPopulation: Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.
This part of the BSID assesses the degree of body control, large muscle coordination, finer manipulatory skills of the hands and fingers, dynamic movement, postural imitation, and the ability to recognize objects by sense of touch.
Outcome measures
| Measure |
Phenobarbital
n=8 Participants
Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months
|
Placebo
n=5 Participants
Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months
|
|---|---|---|
|
Mean Bayley Scales of Infant Development (BSID) Score - Motor
|
82.80 units on a scale
Standard Deviation 24.59
|
83.75 units on a scale
Standard Deviation 20.65
|
SECONDARY outcome
Timeframe: 18-22 monthsPopulation: Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.
Any clinical or electrographic seizures occurring between study entry and all follow-up examinations and contacts.
Outcome measures
| Measure |
Phenobarbital
n=8 Participants
Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months
|
Placebo
n=5 Participants
Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months
|
|---|---|---|
|
Number of Participants With One or More Seizures
|
2 participants
|
1 participants
|
Adverse Events
Phenobarbital
Placebo
Serious adverse events
| Measure |
Phenobarbital
n=8 participants at risk
Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months
|
Placebo
n=5 participants at risk
Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months
|
|---|---|---|
|
Metabolism and nutrition disorders
failure to thrive
|
0.00%
0/8
|
20.0%
1/5
|
|
Nervous system disorders
poor quality sleep
|
12.5%
1/8
|
0.00%
0/5
|
Other adverse events
| Measure |
Phenobarbital
n=8 participants at risk
Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months
|
Placebo
n=5 participants at risk
Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
apnoea
|
0.00%
0/8
|
20.0%
1/5
|
|
Nervous system disorders
convulsion
|
12.5%
1/8
|
20.0%
1/5
|
|
General disorders
Pyrexia
|
37.5%
3/8
|
20.0%
1/5
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/8
|
20.0%
1/5
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/8
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
seborrhoeic dermatitis
|
0.00%
0/8
|
20.0%
1/5
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/8
|
20.0%
1/5
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
37.5%
3/8
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
rash
|
12.5%
1/8
|
0.00%
0/5
|
|
Nervous system disorders
status epilepticus
|
12.5%
1/8
|
0.00%
0/5
|
|
Nervous system disorders
poor quality sleep
|
12.5%
1/8
|
0.00%
0/5
|
|
Infections and infestations
influenza
|
12.5%
1/8
|
0.00%
0/5
|
|
Ear and labyrinth disorders
ear infection
|
25.0%
2/8
|
0.00%
0/5
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
12.5%
1/8
|
0.00%
0/5
|
|
Infections and infestations
sinusitis
|
12.5%
1/8
|
0.00%
0/5
|
|
Ear and labyrinth disorders
otitis media
|
50.0%
4/8
|
0.00%
0/5
|
|
Gastrointestinal disorders
vomiting
|
12.5%
1/8
|
0.00%
0/5
|
|
Infections and infestations
Croup infection
|
12.5%
1/8
|
0.00%
0/5
|
|
Infections and infestations
Candidiasis
|
12.5%
1/8
|
0.00%
0/5
|
|
Infections and infestations
Rhinovirus infection
|
12.5%
1/8
|
0.00%
0/5
|
|
Infections and infestations
Respiratory Syncytial Virus infection
|
12.5%
1/8
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place