Clinical Trial: a Prospective Cohort Study for Propranolol Treatment in Retinopathy of Prematurity

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Safety and Efficacy of Propranolol Treatment in Newborns With Retinopathy of Prematurity:a Prospective Cohort Study

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of oral/local propranolol in preterm newborns who diagnosed as early phase of retinopathy of prematurity (ROP).

Detailed Summary:

The incidence of Retinopathy of Prematurity (ROP) in preterm newborns less than 1500g is about 60% in the developed countries around the world, while there are much more preterm newborns more than 1500g and 32 weeks gestational age with Retinopathy of Prematurity (ROP) had to be treated in the developing countries. ROP has listed top of the five causes lead to blindness in children, which seriously threated children's vision and quality of life.

The ablation of the retina with photocoagulation by laser or cryotherapy reduces the incidence of blindness by suppressing the neovascular phase of ROP. However, those Surgeries require anesthesia and some of them may result in complications such as apnea, neonatal necrotizing enterocolitis, sepsis, and hemorrhage of digestive tract. As a result, it's important to study an alternative non-surgical treatment method.

The development of ROP depends largely from vascular endothelial growth factor (VEGF). The reduction of VEGF expression in the neovascular phase might prevent destructive neovascularization in ROP.

Propranolol is a kind of beta-adrenergic receptor (β-AR) which can inhibit the expression of VEGF and has been first choice of treating infantile hemangioma, the most common tumor of infancy. There are some pilot studies suggesting that the administration of oral propranolol is effective in counteracting the progression of ROP in patients without operation indication. Nevertheless that safety is a concern, for oral propranolol may result in associated complications and side effects such as bradycardia, hypotension, injury of cerebrum growth and olfactory.

Recently a research of eye drop propranolol in a mouse model of oxygen-induced retinopathy (OIR) has shown that proprano
Sponsor: Guangdong Women and Children Hospital

Current Primary Outcome:

  • Number of newborns who have ROP progression [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  • Number of newborns who need surgical treatment [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  • Number of newborns who have side effects [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 months ]
  • Plasma concentrations of propranolol at the steady state measured by dried blood spots [ Time Frame: 10th day of treatment ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • visual assessment of enrolled newborns [ Time Frame: about 12 months ]
  • Scores of Gesell development scale of enrolled newborns [ Time Frame: about 12 months ]


Original Secondary Outcome: Same as current

Information By: Guangdong Women and Children Hospital

Dates:
Date Received: January 19, 2017
Date Started: March 2017
Date Completion: December 2019
Last Updated: February 1, 2017
Last Verified: February 2017