Health Condition 1: P968- Other specified conditions originating in the perinatal period Health Condition 2: D492- Neoplasm of unspecified behavior of bone, soft tissue, and skin
Conditions
Interventions
Intervention1: Topical beta blocker, 0.5% timolol solution (ophthalmic solution): Topical timolol 0.5% eye drops, (calculated number of drops as per body weight) would be applied twice daily with glov
Sponsors
All India Institute of Medical sciences, Raebareli, U.P.
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: All children less than 1. Superficial ICH on Doppler, including mucosal surfaces, and ulcerated ICH 2. Size of lesion > 1.5 Cm 3.No H/O prior tt for ICH 4. Patients at risk of adverse effects of systemic beta-blockers like Cardiac arrhythmias, first-degree heart block; recovered pts of cardiogenic or hypotensive shock, sinus bradycardia, Asthma, history of hypoglycemia, birth weight
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Age at the time of enrolment is >36 months Dermal invasive ICH 2. Life-threatening ICH 3. Persistent arrhythmias, wheezing, heart failure 4. Associated Visceral vascular (liver/ renal/brain) lesions 5. Patients Having Raynaud phenomena 6. Bradycardia below the age-specific range for normal 7. Low blood pressure according to age-specific ranges for normal 8. known case of Pheochromocytoma 9. Breast-feeding mothers who are on treatment with oral propranolol 10. Renal failure 11. liver failure 12. Hyperkalemia 13. Psoriasis in infant 14. Infant or mother taking other drugs having synergistic, antagonistic action with beta blockers viz calcium channel blocker (Diltiazem, Verapamil, bepridil), Quinidine, Amiodarone (antiarrhythmic), Digitalis, Lidocaine, Dihydropyridines, Antihypertensives (ACE Inhibitors, angiotensin II-receptors antagonists, diuretics, alpha-blocker, Corticosteroid, (nitrates derivatives, type 5-phosphodiesterase inhibitors, tricyclic antidepressants, antipsychotics, dopaminergic agonists, levodopa, amifostine, baclofen, rifampicin or phenobarbital and Hypoglycaemic agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures would be followed in the Proportion of patients in each group. To compare combined VAS scores in two groups (excellent & good responses will be taken as treatment success).Timepoint: VAS scores in two groups at the 1st week, 2nd week, 3rd week, 4th week, 8th week, 12th week, 16th week, 20th week, 24th week months. A follow-up of 12 months will be done till the stop of treatment to see the rebound growth of ICH. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events/Side effects of topical therapy viz local burning, stinging, or irritant reactions. Timolol Safety would be assessed by measuring heart rate & systolic and diastolic blood pressure. Parental satisfaction on 10 points line scale at the 24th week and stoppage of treatment. Timepoint: At 1st week, 2nd week, 3rd week, 4th week, 8th week, 12th week, 16th week, 20th week, 24th week. | — |
Countries
India
Contacts
Public ContactDr Sunita Singh
All India Institute of Medical Sciences, Raebareli
Outcome results
None listed