Recurrent Crying Spells
Conditions
Keywords
Baclofen, cerebral palsy, colic, crying infant, recurrent crying spells, spasticity, therapy
Brief summary
This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.
Detailed description
This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.
Interventions
DRUGBaclofen
Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used.
OTHERPlacebo
Sponsors
Sathbhavana Brain Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
No
Inclusion criteria
* Recurrent Crying Spells in Cerebral Palsy with Spastic Quadriparesis. * Age range 0-12 years.
Exclusion criteria
* Crying due to known causes (like hunger, sleep, food intolerance etc.), * Crying that responded to routine management (changes in food or feeding techniques, anticolic, analgesics), * Fever of ≥100.4ºF (38ºC), * The infant refuses to eat or drink for more than a few hours, vomits excessively, has bloody stools, or has a change in behavior (lethargy or decreased responsiveness). * Colic * Worst ever crying occurring for the first time * Respiratory, renal and hepatic diseases, * Progressive encephalopathies, * Received Baclofen in the previous 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline cry duration in seconds over a 10-day period while on placebo. | 11th to 20th day and 51st day to 60th day | Cry duration in seconds over a 10-day period while on placebo was compared to that of Baclofen. |
Countries
India
Outcome results
None listed