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Oral propranolol versus placebo for retinopathy of prematurity: a pilot, randomised, double-blind prospective study
  1. Imad R Makhoul1,
  2. Ofra Peleg2,
  3. Benjamin Miller3,
  4. Benjamin Bar-Oz2,
  5. Orna Kochavi3,
  6. Hadas Mechoulam4,
  7. Eedy Mezer3,
  8. Irena Ulanovsky1,
  9. Tatiana Smolkin1,
  10. Claudia Yahalom4,
  11. Asaad Khoury5,
  12. Avraham Lorber5,
  13. Amiram Nir6,
  14. Shraga Blazer1
  1. 1 Department of Neonatology, Meyer Children's Hospital, Rambam Health Care Campus and Rappaport Faculty of Medicine, Technion—Israel Institute of Technology, Haifa, Israel
  2. 2 Department of Neonatology, Hadassah Medical Center, Faculty of Medicine, Hebrew University, Jerusalem, Israel
  3. 3 Department of Ophthalmology, Rambam Health Care Campus and Rappaport Faculty of Medicine, Technion—Israel Institute of Technology, Haifa, Israel
  4. 4 Department of Ophthalmology, Hadassah Medical Center, Faculty of Medicine, Hebrew University, Jerusalem, Israel
  5. 5 Department of Pediatric Cardiology, Meyer Children's Hospital, Rambam Health Care Campus and Rappaport Faculty of Medicine, Technion—Israel Institute of Technology, Haifa, Israel
  6. 6 Department of Pediatric Cardiology, Hadassah Medical Center, Faculty of Medicine, Hebrew University, Jerusalem, Israel
  1. Correspondence to Dr Imad R Makhoul, Associate Clinical Professor of Pediatrics, Department of Neonatology, Rambam Medical Center, Bat-Galim, Haifa 31096, Israel; makhoul{at}rambam.health.gov.il

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Retinopathy of prematurity (ROP) can progress to neovascularisation (NV) and retinal detachment. Laser photocoagulation1 or intravitreal bevacizumab (Avastin)2 are the current interventions for severe ROP. Vascular endothelial growth factor (VEGF) plays a key role in ROP pathogenesis, being downregulated and upregulated in vaso-obliterative and vaso-proliferative phases of ROP, respectively. ROP and infantile haemangiomas share the same VEGF-mediated pathogenesis. Propranolol downregulates VEGF expression, and thus, mitigates progression of infantile haemangiomas3 and NV in oxygen-induced retinopathy in animals.4 We examined the safety and feasibility of propranolol for ROP.

Twenty premature infants with ROP, born between 1 May 2010 and 31 July 2012 at 24–28 weeks’ gestation and birth weight <1500 g, were randomised either to oral propranolol (propranolol+sucrose 5%; n=10) or placebo (sucrose 5%; n=10) (figure 1). Inclusion criterion: evidence for ROP with any of the following: (a) stage 1 (zone I); (b) stage 2 or …

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Footnotes

  • Contributors IRM, OP and BB-O conceptualised and designed the study, analysed data, drafted the initial manuscript, reviewed and revised the manuscript and approved the final manuscript as submitted. BM supervised and interpreted the retinal findings, reviewed and revised the manuscript and approved the final manuscript as submitted. OK, HM, EM and CY performed and interpreted the retinal findings, reviewed and revised the manuscript and approved the final manuscript as submitted. IU and TS  designed the data collection instruments, collected the data, carried out the initial analyses, reviewed the manuscript and approved the final manuscript as submitted. AK and AL supervised safety of propranolol therapy and interpreted ECG findings and reviewed and revised the manuscript, and approved the final manuscript as submitted. SB coordinated and supervised data collection, reviewed the manuscript and approved the final manuscript as submitted.

  • Competing interests None.

  • Patient consent Obtained.

  • Ethics approval Institutional Helsinki Committees at the two participating centres, Rambam Medical Center, Haifa; and Hadassah Medical Center, Jerusalem; and also by the Israeli Ministry of Health.

  • Clinical trial registration number ClinicalTrials.gov Identifier: NCT012384.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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