Recurrent Crying Spells in Cerebral Palsy

Phase 4

Completed

• Conditions: Recurrent Crying Spells
• Interventions: Other: Placebo; Drug: Baclofen

• Registration Number: NCT01955655
• Lead Sponsor: Sathbhavana Brain Clinic

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.

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted: 2013-09-21
• Study First Submitted QC: 2013-09-29
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-06
• Study First Posted: 2013-10-07
• Last Update Posted: 2013-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Placebo contained fructose powder in equal quantity in packets mimicking those of Baclofen.
Baclofen	Baclofen	The starting dose was 0.75 mg/kg in four divided doses daily and was cautiously increased at three-day intervals until crying subsided or symptoms of over dosage or side effects appeared. The usual maximum dose was two mg/kg in four divided doses daily.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sathbhavana Brain Clinic; 🇮🇳 Secunderabad, Andhra Pradesh, India