Trial Outcomes & Findings for Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study (NCT NCT01238471)

Results Overview

If ROP regresses without the need for treatment (laser and/or CRYO), this will be considered a favorable outcome. On the other hand, if ROP progresses to require treatment, it will be regarded as an unfavorable outcome. Evidence for regression of ROP was observed by serial retinal examinations performed by ophthalmologists as well as by reduction for the need of invasive interventions such as laser photocoagulation of disease areas in the retina.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

propranolol therapy for up 4 weeks

Results posted on

2014-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Propranolol Oral propranolol for premature infants allocated to this arm by randomization propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks	Oral Sucrose 5% Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propranolol n=10 Participants Oral propranolol for premature infants allocated to this arm by randomization propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks	Oral Sucrose 5% n=10 Participants Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks	Total n=20 Participants Total of all reporting groups
Age, Continuous	60.9 days STANDARD_DEVIATION 4.9 • n=5 Participants	64.4 days STANDARD_DEVIATION 10.5 • n=7 Participants	62.6 days STANDARD_DEVIATION 7.7 • n=5 Participants
Age, Categorical <=18 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Israel	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: propranolol therapy for up 4 weeks

If ROP regresses without the need for treatment (laser and/or CRYO), this will be considered a favorable outcome. On the other hand, if ROP progresses to require treatment, it will be regarded as an unfavorable outcome. Evidence for regression of ROP was observed by serial retinal examinations performed by ophthalmologists as well as by reduction for the need of invasive interventions such as laser photocoagulation of disease areas in the retina.

Outcome measures

Outcome measures
Measure	Propranolol n=10 Participants Oral propranolol for premature infants allocated to this arm by randomization propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks	Oral Sucrose 5% n=10 Participants Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks
Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy	4 cases	8 cases

SECONDARY outcome

Timeframe: 4 weeks of propranolol therapy in premature infants

Close monitoring for possible side effects of propranolol in premature infants

Outcome measures

Outcome data not reported

Adverse Events

Propranolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Sucrose 5%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Propranolol n=10 participants at risk Oral propranolol for premature infants allocated to this arm by randomization propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks	Oral Sucrose 5% n=10 participants at risk Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks
Cardiac disorders bradycardia	0.00% 0/10	0.00% 0/10

Other adverse events

Adverse event data not reported

Additional Information

Professor Imad Makhoul

Rambam Medical Center

Phone: 972-4-8542219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER