Status:
COMPLETED
Excessive Crying in Children With Cerebral Palsy and Communication Deficits
Lead Sponsor:
Sathbhavana Brain Clinic
Conditions:
Cerebral Palsy
Excessive Crying
Eligibility:
All Genders
Up to 15 years
Phase:
PHASE4
Brief Summary
Management of excessive crying in children with cerebral palsy and communication deficits \[ECCCPCD\] was guided by the associated clinical findings and investigations.
Detailed Description
Pain treatments are frequently hit or miss, trial \& error, or because of the fear of litigations, not offered at all, particularly in cerebral palsy. Pain is an under-suspected and under-diagnosed ca...
Eligibility Criteria
Inclusion
- A child with cerebral palsy under the age of 15 years and could not communicate the reason for excessive crying because of young age or global developmental delay/profound intellectual retardation.
- Excessive crying of \>7.5 hours daily for 30 consecutive days unresponsive to treatment by the pediatrician, orthopedic surgeon, gastroenterologist, and physiotherapist.
- Minimum cry intensity for recording: If the intensity of crying was so high that the caregiver could not hear radio, TV, or another person talking to her \[sitting near her\], the cry duration was recorded.
- History, clinical, and neuroimaging findings (structural MRI) were suggestive of chronic static encephalopathy.
- Motor impairment could be explained by an insult that occurred in the developing fetal or infant brain.
- Exclusion Criteria:
- Medicines used in the study were used in the previous 30 days, and it was impossible to taper off the drugs without worsening of symptoms.
- Excessive crying due to known causes.
- Progressive encephalopathies.
Exclusion
Key Trial Info
Start Date :
December 7 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2020
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT04523935
Start Date
December 7 2005
End Date
August 4 2020
Last Update
October 28 2021
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