Recurrent Crying Spells in Cerebral Palsy

Phase 4CompletedNCT01955655

Sathbhavana Brain Clinic70 enrolled

Overview

This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.

This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Recurrent Crying Spells

Interventions

BaclofenDRUG

Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used.

PlaceboOTHER

Eligibility

Sex: ALLMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Sathbhavana Brain Clinic

Secunderabad, Andhra Pradesh, India

Outcomes

Primary Outcomes

Change from baseline cry duration in seconds over a 10-day period while on placebo.

Cry duration in seconds over a 10-day period while on placebo was compared to that of Baclofen.

Time frame: 11th to 20th day and 51st day to 60th day

Data from ClinicalTrials.gov

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