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Oral Propranolol Improve Retinopathy of Prematurity Outcomes in Very Preterm Infants

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ClinicalTrials.gov Identifier: NCT02977000
Recruitment Status : Unknown
Verified November 2016 by Huiqing Sun, Zhengzhou Children's Hospital, China.
Recruitment status was:  Recruiting
First Posted : November 30, 2016
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Huiqing Sun, Zhengzhou Children's Hospital, China

Brief Summary:

Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in children in both developing and developed countries around the world. ROP is a multifactorial disease characterized by perturbation of normal vascular development in the retina. The pathogenesis of ROP is hypothesized to consist of two distinct phases of which the second phase is characterized by hypoxia-induced up-regulation of vascular endothelial growth factor (VEGF) and retinal neovascularization.

Recent studies have shown a relationship between the β-adrenergic system and angiogenesis. This relationship has been observed in several diseases, like infantile hemangiomas, ROP, and neoplasias. Studies in animal models have shown that norepinephrine stimulates VEGF expression and secretion in retinal cells. In oxygen induced retinopathy, blockage of β-adrenergic receptors (β-AR) can inhibit the angiogenic cascade and interfere with further proliferation of retinal vasculature. Also, angiogenesis seems to be impaired in β-Argene deficient mice, when exposed to hypoxia and other stimuli, but this function is restored after gene therapy.

Assuming in human preterm newborns with ROP that VEGF overexpression and retinal neovascularization in response to hypoxia might involve b-AR activation, we design prospective randomized study to assess the effect of oral propranolol on the progression of early stages of ROP in very low birth weight infants.


Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Drug: Propranolol Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Department of Neonatology, Children's Hospital of Zhengzhou
Study Start Date : May 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2018


Arm Intervention/treatment
Experimental: Propranolol
Propranolol was administered orally as a dose of 1.5 mg/kg.d divided q8h. investigators used powdered drug, dissolved in 5% dextrose. The treatment was continued until complete development of retinal vascularization, although administration was not permitted for more than 90 days.
Drug: Propranolol
Propranolol was administered orally as a dose of 1.5 mg/kg.d divided q8h.investigators used powdered drug, dissolved in 5% dextrose. The treatment was continued until complete development of retinal vascularization, although administration was not permitted for more than 90 days.




Primary Outcome Measures :
  1. The rates of regression of Retinopathy of Prematurity [ Time Frame: 2 years ]


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Ages Eligible for Study:   24 Weeks to 45 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • preterm newborns with GA <32 weeks of age and Stage 2 ROP without plus in zone II

Exclusion Criteria:

  • newborns with congenital or acquired cardiovascular anomalies, renal failure or cerebral hemorrhage at enrollment, and newborns with ROP in zone I or at a more advanced stage than Stage 2 without plus in zone II.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977000


Contacts
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Contact: Hunqing Sun, PhD 13838112692 s_huiqing@sina.com

Locations
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China, Henan
Propranolol Recruiting
Zhengzhou, Henan, China, 450000
Contact: Huiqing Sun, PhD    13838112692    s_huiqing@sina.com   
Sponsors and Collaborators
Huiqing Sun
Investigators
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Study Chair: Ligong Hou, MD Chidren's Hospital of Zhengzhou

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Responsible Party: Huiqing Sun, Department of Neonatology, Zhengzhou Children's Hospital, China
ClinicalTrials.gov Identifier: NCT02977000     History of Changes
Other Study ID Numbers: ROP-PROP
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Propranolol
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents