a Prospective Cohort Study for Propranolol Treatment in Retinopathy of Prematurity

NCT03038295 | Unknown Phase 2 DMC

• 1 other identifier: lqiong
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of Prematurity; propranolol; ROP

Outcome Measures

Primary Outcomes (4)

• Number of newborns who have ROP progression

  participants will be followed for the duration of hospital stay, an expected average of 2 months

• Number of newborns who need surgical treatment

  participants will be followed for the duration of hospital stay, an expected average of 2 months

• Number of newborns who have side effects

  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

  10th day of treatment

Secondary Outcomes (2)

• visual assessment of enrolled newborns

  about 12 months

• Scores of Gesell development scale of enrolled newborns

  about 12 months

Study Arms (4)

oral propranol group

EXPERIMENTAL

Enrolled preterm newborns will receive oral propranolol 0.25mg/kg daily(every 24 hours). The treatment will be started as soon as the diagnosis of stage 1 or 2 ROP without plus is made and will be continue until the development of retinal vascularization is completed, but no more than 90 days.

Drug: Propranolol

oral placebo group

PLACEBO COMPARATOR

Enrolled preterm newborns will receive oral normal saline 0.25mg/kg daily(every 24 hours) and other disposals will be done similarily to the oral propranol group.

Drug: placebo

eye drop propranol group

EXPERIMENTAL

Enrolled preterm newborns will receive propranolol as ophthalmic solution (0.2%). 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette,in each eye, four times daily (every 6 hours) . The treatment will be started as soon as the diagnosis of stage 1 or 2 ROP without plus is made and will be continue until the development of retinal vascularization is completed, but no more than 90 days.

Drug: Propranolol

eye drop placebo group

PLACEBO COMPARATOR

Enrolled preterm newborns will receive placebo as ophthalmic solution in the same way of eye drop propranolol and other disposals will be done similarily to the eye drop propranol group.

Drug: placebo

Interventions

Propranolol DRUG

Oral propranolol:0.25mg/kg daily(every 24 hours)；Eye drop propranolol(0.2%):3 microdrops,in each eye, four times daily (every 6 hours) .Both administration routes will be discontinued until retinal vascularization will be completed, but no more than 90 days.The study will be discontinued immediately in the presence of serious adverse effects attributable to the pharmacological actions of propranolol (severe hypotension, bradycardia or bronchospasm).In case of surgery or induction of anesthesia during the administration of propranolol, the drug should be discontinued at least 24 hours before surgery.In cases of severe hypotension or bradycardia may be administered one or more of the following drugs:Atropine.Isoproterenol hydrochloride (isoprenaline).Terlipressin.Glucagon In case of severe bronchospasm may be used salbutamol aerosol or salbutamol + ipratropium bromide. Betamethasone could be used for aerosol or systemic (intravenous or intramuscular).

eye drop propranol group; oral propranol group

placebo DRUG

Oral/eye drop placebo will be taken in enrolled newborns. Other treatment will follow the standard treatment schedule of Early Treatment For Retinopathy Of Prematurity Cooperative Group.

Also known as: normal saline

eye drop placebo group; oral placebo group

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm newborns (birth weight less than 1500g) with stage 1/2 ROP in Zone 2 or 3 without plus
• A signed parental informed consent

You may not qualify if:

• Newborns with heart failure
• Newborns with recurrent bradycardia (heart rate \< 90 beat per minute)
• Newborns with second or third degree atrioventricular block
• Newborns with congenital cardiovascular anomalies, except for persistent ductus arteriosus, patent foramen ovale and small ventricular septal defects
• Newborns with hypotension
• Newborns with renal failure
• Newborns with actual cerebral haemorrhage
• Newborns with other diseases which contraindicate the use of beta-adrenoreceptor blockers.
• Newborns with a more severe stage of ROP than stage 2 or in Zone 1

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

Related Publications (4)

• Zin A, Gole GA. Retinopathy of prematurity-incidence today. Clin Perinatol. 2013 Jun;40(2):185-200. doi: 10.1016/j.clp.2013.02.001.

  PMID: 23719304 BACKGROUND

• Fierson WM; American Academy of Pediatrics Section on Ophthalmology; American Academy of Ophthalmology; American Association for Pediatric Ophthalmology and Strabismus; American Association of Certified Orthoptists. Screening examination of premature infants for retinopathy of prematurity. Pediatrics. 2013 Jan;131(1):189-95. doi: 10.1542/peds.2012-2996. Epub 2012 Dec 31.

  PMID: 23277315 BACKGROUND

• Filippi L, Cavallaro G, Bagnoli P, Dal Monte M, Fiorini P, Donzelli G, Tinelli F, Araimo G, Cristofori G, la Marca G, Della Bona ML, La Torre A, Fortunato P, Furlanetto S, Osnaghi S, Mosca F. Oral propranolol for retinopathy of prematurity: risks, safety concerns, and perspectives. J Pediatr. 2013 Dec;163(6):1570-1577.e6. doi: 10.1016/j.jpeds.2013.07.049. Epub 2013 Sep 18.

  PMID: 24054431 BACKGROUND

• Dal Monte M, Casini G, la Marca G, Isacchi B, Filippi L, Bagnoli P. Eye drop propranolol administration promotes the recovery of oxygen-induced retinopathy in mice. Exp Eye Res. 2013 Jun;111:27-35. doi: 10.1016/j.exer.2013.03.013. Epub 2013 Mar 23.

  PMID: 23528535 BACKGROUND

Related Links

• Drug Information

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Propranolol; Saline Solution

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Chuan Nie, Doctor

  Guangdong Women and Children Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuan Nie, Doctor

CONTACT

+86-136-8227-0294; chuannie@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of Department of Neonatology

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 31, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share