Cerebral Palsy, GERD
Conditions
Keywords
GERD
Brief summary
Despite the use of proton pump inhibitors and available prokinetics, medical therapy is ineffective in an important number of children with cerbreal palsy (CP) and gastroesophageal reflux disease (GERD), and failure of medical therapy is associated with a substantial morbidity. Many patients, particularly children with CP and GERD, continue to experience complications despite aggressive therapy because antisecretory medications do not address the primary reflux mechanism (TLESR). Furthermore, in patients with CP, surgical options are fraught with serious complications and long-term morbidity. Because the available treatment options for children with CP and intractable GERD are limited, new therapies are urgently needed. Baclofen, which has been shown in animals and humans to decrease TLESRs, may be a good alternative for the treatment of children with CP with intractable GERD.
Detailed description
Despite the use of proton pump inhibitors and available prokinetics, medical therapy is ineffective in an important number of children with cerbreal palsy (CP) and gastroesophageal reflux disease (GERD), and failure of medical therapy is associated with a substantial morbidity. Many patients, particularly children with CP and GERD, continue to experience complications despite aggressive therapy because antisecretory medications do not address the primary reflux mechanism (TLESR). This is a placebo controlled trial of baclofen for the treatment of GERD in children with CP.
Interventions
DRUGBaclofen
The final baclofen dose will be 0.7 mg/kg (to a maximum of 40 mg/day) divided in three doses.
DRUGplacebo
placebo. No other names
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 3-18 years old * Diagnosis of Cerebral Palsy * Symptoms of GERD for at least 3 months * At least 8 weeks on BID therapy with a PPI at a therapeutic dose at time of enrollment * Normal upper gastrointestinal barium contrast study (UGI) * Have a g-tube that is used for more than 75% of calories and a stable feeding schedule for at least 2 weeks * If seizures are present, they need to be controlled and on stable medications for 4 weeks
Exclusion criteria
* Underlying electrolyte disturbance * History of Nissen fundoplication * Renal insufficiency * Currently receiving baclofen * Baclofen allergy * Uncontrolled seizure disorder * Lack of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom control | 3 weeks | Symptom frequency during the 2 weeks of placebo and baclofen administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GERD control | 3 weeks | Frequency and duration of reflux episodes detected by MII during 24 hours of recording after two weeks of maximum dose. Proportion of full-column and non-acid reflux episodes detected by MII during 24 hours after two weeks of maximum dose. Frequency of TLESRs and reflux associated with TLESRs at half of the maximum dose, and after two weeks of maximum dose are administered |
| side effects of baclofen | 3 weeks | Incidence of side effects and rate of discontinuation of the study |
Countries
United States
Outcome results
None listed