NCT00642135

Brief Summary

Pupillary dilation to perform a fundus in premature newborns and neonates is often difficult to obtain, because of the non mature iris sphincter. The fundus is essential to detect retinal anomalies (as retinopathy of prematurity or chorioretinal or disk anomalies). The aim of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study will evaluate the mydriasis in premature newborns, neonates and infants justifying a mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic insert Mydriasert® can control drug dispensation and decrease the number of nurse interventions to obtain mydriasis in patients.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 10, 2008

Status Verified

January 1, 2006

Enrollment Period

2.1 years

First QC Date

March 17, 2008

Last Update Submit

April 9, 2008

Conditions

Retinal AnomaliesPremature Birth

Keywords

prematureneonatesinfantschildrenMydriasert®mydriasisfundusTropicamidePhenylephrineclinical trialInfantpremature newbornsbilateral diagnosis fundus

Outcome Measures

Primary Outcomes (1)

  • Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.

    75 minutes

Secondary Outcomes (5)

  • Frequency of the nurse intervention to obtain the mydriasis

    during 215 minutes maximum

  • Calculation of the dose of active drugs administrated

    one day

  • Local and systemic clinical tolerance

    one day

  • Occurrence of adverse reactions

    one day

  • Stability of a mydriasis of good quality at T+195

    at T+195 minutes

Study Arms (2)

1

ACTIVE COMPARATOR

Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops

Drug: phenylephrine and tropicamide eyedrops

2

ACTIVE COMPARATOR

Premature newborns and neonates treated using insert Mydriasert®

Drug: Mydriasert®

Interventions

Mydriasert®DRUG

Premature newborns and neonates treated using ophthalmologic insert Mydriasert®

2
phenylephrine and tropicamide eyedropsDRUG

Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)

1

Eligibility Criteria

AgeUp to 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Premature newborns, neonates and infants of less 18 months-old indoor in the neonatology clinical department of Robert Debre Hospital with cardiologic monitoring
  • Presenting a risk of retinopathy of prematurity or fundus anomaly (chorioretinal and/or disk anomalies).
  • Needing a bilateral fundus
  • Parents, tutor or legal representing of the patient had been informed of objectives of the study and had given their written consent.
  • Covered by French social security or CMU

You may not qualify if:

  • Contra-indication to one of the evaluated drugs
  • Any treatment that could provoke a dangerous drug interaction for the patient if associated with one of the drug of the study
  • Anatomical predisposition to glaucoma, hypertension or any other contra-indication noted by the physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Robert Debré

Paris, 75019, France

Location

MeSH Terms

Conditions

Premature BirthMydriasis

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPupil DisordersEye Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Dominique BREMOND GIGNAC, MD

    Hôpital Robert Debré, APHP, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 24, 2008

Study Start

January 1, 2006

Primary Completion

February 1, 2008

Study Completion

June 1, 2008

Last Updated

April 10, 2008

Record last verified: 2006-01

Locations

FR(1)