Interventions for preventing ophthalmia neonatorum

Interventions for preventing ophthalmia neonatorum
(Protocol)
Kapoor VS, Whyte R, LaRoche RR
This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The CochraneLibrary 2009, Issue 1 Interventions for preventing ophthalmia neonatorum (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
T A B L E O F C O N T E N T S
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Interventions for preventing ophthalmia neonatorum (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]
Interventions for preventing ophthalmia neonatorum
Vimal S Kapoor1, Robin Whyte2, Robert R LaRoche3 1University of Toronto, Toronto, Canada. 2Department of Neonatal Pediatrics, IWK-Grace Health Centre, Halifax, Canada.
3Department of Ophthalmology, IWK-Grace Health Centre, Halifax, Canada (Editorial group: Cochrane Eyes and Vision Group.) Cochrane Database of Systematic Reviews, Issue 1, 2009 (Status in this issue: Edited)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DOI: 10.1002/14651858.CD001862
This version first published online: 25 October 1999 in Issue 4, 1999. Re-published online with edits: 21 January 2009 in Issue 1,
2009. (Help document - explained)
This record should be cited as: Kapoor VS, Whyte R, LaRoche RR. Interventions for preventing ophthalmia neonatorum. Cochrane
Database of Systematic Reviews 1999, Issue 4. Art. No.: CD001862. DOI: 10.1002/14651858.CD001862.
A B S T R A C T
This is the protocol for a review and there is no abstract. The objectives are as follows: (1) to determine if any type of ophthalmic prophylaxis reduces the incidence of conjunctivitis in neonates.
(2) to determine which ophthalmic prophylactic medication is most effective at reducing the incidence of conjunctivitis in neonates.
Interventions for preventing ophthalmia neonatorum (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
B A C K G R O U N D
Recently, promising results have been found for povidone-iodineas a prophylactic agent ). It has Ophthalmia neonatorum, also called neonatal conjunctivitis, is an many advantages over silver nitrate, erythromycin and tetracycline, inflammatory disorder of the ocular surface of neonates caused including a broader antibacterial spectrum and lack of bacterial primarily by bacteria and less often by viruses and chemical agents (It can lead to permanent damage of the eye andblindness.
Currently, it remains unresolved which drug regimen to administerfor ophthalmia neonatorum prophylaxis. This is partly due to the The major pathogens responsible for ophthalmia neonatorum are lack of studies, partly due to a lack of good quality, conclusive Chlamydia trachomatis, Staphylococcus aureus, Neisseria gonor- studies, and partly due to the lack of appropriate reviews of the rhoeae, Streptococcus and Haemophilus (). The most serious type of ophthalmia neonatorum is gonococcal con-junctivitis which is caused by Neisseria gonorrhoeae ). This can lead to perforation of the intact corneal epithe-lium and loss of the eye ). In some settings, the O B J E C T I V E S
most common type of ophthalmia neonatorum is chlamydial con- junctivitis which is caused by Chlamydia trachomatis ).
(1) to determine if any type of ophthalmic prophylaxis reduces theincidence of conjunctivitis in neonates.
Ophthalmia neonatorum is mainly contracted from the mother’sinfected birth canal during delivery, but can also be contracted (2) to determine which ophthalmic prophylactic medication is in-utero by ascending infections and postnatally by contaminated most effective at reducing the incidence of conjunctivitis in secretions from family members (; ).
The World Health Organization estimates that in 1995 there were62.2 million new cases of gonorrhoea and 89.1 million new casesof chlamydia in adults aged 15-49 years of age globally ). Most of these new cases occurred in the developing world.
Approximately 28 per cent of the infants born to women with Criteria for considering studies for this review
Neisseria gonorrhoeae will develop gonococcal conjunctivitis and18 to 50 per cent of infants born to women with Chlamydia tra- Types of studies
chomatis will develop chlamydial conjunctivitis ).
We will consider randomised and quasi-randomised trials.
Hence, the worldwide potential for ocular morbidity and blind- Types of participants
Participants will be all newborn infants receiving some prophylac- Prophylaxis has significantly reduced the risk of the newborn de- tic medication or placebo for ophthalmia neonatorum after birth.
veloping ophthalmia neonatorum. However, the relative efficacy Types of interventions
of various prophylactic agents has not been resolved. Karl S.F.
Crede introduced silver nitrate prophylaxis in 1881, which re- We will consider any topical, systemic or combination medication duced the incidence of gonococcal conjunctivitis from 10 to 0.3 which has been compared to placebo and/or other topical, systemic per cent ). However, the emergence of Chlamydia trachomatis as the leading cause of ophthalmia neonatorum and Types of outcome measures
the ineffectiveness of silver nitrate against Chlamydia trachomatis has driven a re-examination of the prophylactic agent ( (1) Proportion of infants developing infectious conjunctivitis by type of organism, for example gonococcal conjunctivitis, chlamy- Erythromycin and tetracycline gained acceptance as prophylactic agents in the 1980’s because of their allegedly superior activity (2) Number of colony-forming units per eye against Chlamydia trachomatis and because they lacked some side (3) Number of different species of bacteria cultured per eye effects of silver nitrate, such as chemical conjunctivitis (4) Time to onset of ophthalmia neonatorum ). However, it remains unresolved whether these antibiotic agents are, in fact, any more effective than silver nitrate in prevent- (6) Impairment of maternal-infant bonding ing chlamydial conjunctivitis. Further, the emergence of beta-lac- Maternal and infant behaviours during care and during breast tamase-producing Neisseria gonorrhoeae has reduced the prophy- feeding have been assessed in some studies by observation and in- lactic effectiveness of erythromycin and tetracycline ).
terviews. During observation, behaviour has been quantified by Interventions for preventing ophthalmia neonatorum (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
tally four to five days postpartum after administration of prophy- Three reviewers will assess the titles and abstracts resulting from laxis. Structured interviews have been carried out four to five days the electronic searches. The full copy of all relevant or potentially postpartum and six to eight weeks postpartum.
relevant trials will be obtained and assessed according to the ’Cri- teria for considering studies for this review’. Only trials meeting Visual alertness has been assessed by the ability of the infant to these criteria will be assessed for methodological quality. The re- open their eyes for alertness and scanning after administration viewers will not be masked to any trial details during the assess- of eye prophylaxis. This has been scored according to the scale ment. Disagreements about whether a trial should be included will be resolved by discussion and consensus. In cases where additional information is needed before a decision can be made whether to (1) opens eyes for short moments several times include a trial, we will attempt to obtain this information from Assessment of methodological quality
Trial quality will be assessed according to the methods set out in Section 6 of the Cochrane Reviewer’s Handbook and the Cochrane Eyes and Vision Group Methodology Guide for Reviewers. This (a) proportion of infants developing noninfectious conjunctivitis, assessment will be made by at least two reviewers. We will use the following components to determine methodological quality: (b) incidence of nasolacrimal duct obstruction (1) Allocation concealment: This is determined by the method of (c) pain reaction. Assessed by measuring the length of the cry allocation used in the randomised trial and graded as adequate, unclear or inadequate. In this way, any selection bias can be ascer- (d) eye irritation including swelling of eyelids, redness of conjunc- (2) Performance bias: Trials will be graded based on whether the recipients of care were unaware of their assigned treatment and whether the persons providing care were unaware of the assigned Compliance includes aspects such as ease of administration of the (3) Detection bias: The trials will be graded according to the aware- prophylactic medication, ease of preparation of the prophylactic ness of the persons responsible for outcome assessment to the as- medication, stability of the medication, and whether the prophy- lactic medication marks the eye in some way (for example, colour) (4) Attrition bias: This will be assessed in the trials by comparing to determine if the medication has been administered.
the rates of follow-up in the treatment groups and by determiningwhether the analysis was ’intention to treat’.
Search methods for identification of studies
A global rating will be made of the trial as ’low risk of bias’, ’mod-erate risk of bias’ or ’high risk of bias’ based on the responses to the Electronic searches
above four components. This rating will be applied according to We will identify studies by searching the Cochrane Controlled the guidelines in the Cochrane Eyes and Vision Group Method- Trials Register - CENTRAL (which includes the Cochrane Eyes and Vision Group specialised register) and MEDLINE.
The independent appraisals will be compared for differences and See: for details of search strategies for the electronic any discrepancies will be resolved by discussion. The consensus agreement will be recorded using a separate printed form. Relia- Searching other resources
bility will be examined throughout the data collection process toavoid ’coder drift’.
We will use the Science Citation Index to locate studies whichhave cited the identified trials. We will check the reference lists Data collection
of identified trial reports and existing review articles to identify Two reviewers independently will extract data onto forms devel- additional trials. We will contact the authors of identified trials, oped by the Cochrane Eyes and Vision Group using Section 7 pharmaceutical companies and experts in the area to locate fur- of the Cochrane Reviewer’s Handbook, the Cochrane Eyes and ther trials. Hand-searching efforts will be undertaken to identify Vision Group Methodology and Statistical Guides for Reviewers.
Authors of trials will be contacted to try to obtain missing data.
Data analysis
Data collection and analysis
Data analysis will be conducted using the following as guides:Section 8 of the Cochrane Reviewer’s Handbook and the Cochrane Selection of trials
Eyes and Vision Group Statistical Guide for Reviewers.
Interventions for preventing ophthalmia neonatorum (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
For dichotomous data, results will be expressed as odds ratio esti- (1) Excluding studies of lower methodological quality mates or risk ratio estimates (95% confidence intervals). Also, the risk difference or the number needed to treat will be obtained (95% confidence intervals). Results will be summarised across studies using the odds ratio or relative risk and/or the risk difference.
(b) excluding trials conducted in developed country settings For continuous data, the mean and standard deviation will be ob- (c) excluding trials conducted in developing country settings tained; if the data are skewed, the median and inter quartile range (4) Excluding studies which have assumed that eyes within an will be obtained. Standard errors will be converted to standard deviations. If trial results are only reported as mean differences, in- (5) Excluding studies where follow-up has not been continued for vestigators will be contacted to obtain the mean and standard de- viation. Results will be summarised across studies using weighted We will perform cost-effectiveness analysis where data permit.
mean differences (95% confidence intervals).
The effect of differences in the definitions and measurement ofoutcomes, such as diagnosis of conjunctivitis and infections anddifferences in length of follow-up, will be examined using meth-ods for addressing clinical heterogeneity: sub-group analysis and A C K N O W L E D G E M E N T S
meta-regression. If any other significant heterogeneity is detectedbetween studies, sub-group analysis will be carried out and pool- • We wish to thank Karen Neves at the Kellogg Health Sciences Library, Chris Emeneau at Medical Comput- Sensitivity analysis will be conducted with the following adjust- ing, and the Cochrane Eyes and Vision Group for their • We are grateful to Haroon Saloojee for peer review com- R E F E R E N C E S
Additional references
Isenberg 1994
Isenberg SJ (Ed). The eye in infancy. 2nd Edition. St Louis: Mosby, Albert 1994
Albert DM, Jakobiec FA (Eds). Principles and practice of ophthalmol-ogy: clinical practice. Philadelphia: W.B. Saunders Company, 1994.
Isenberg 1994b
Canadian 1992
Isenberg SJ, Apt L, Yoshimori R, Leake R, Rich R. Povidone-iodine Canadian Task Force on the Periodic Health Examination. Periodic for ophthalmia neonatorum prophylaxis. American Journal of Oph- health examination, 1992 update: 4. Prophylaxis for gonococcal and thalmology 1994;118(6):701–706.
chlamydial ophthalmia neonatorum. Canadian Medical Association
Journal 1992;147(10):1449–1454.
Isenberg 1995
Isenberg SJ, Apt L, Wood M. A controlled trial of povidone-iodine Clarke 2000
as prophylaxis against ophthalmia neonatorum. The New England Clarke M, Oxman AD, editors. Cochrane Reviewers’ Handbook Journal of Medicine 1995;332(9):562–566.
4.1 [updated June 2000]. Review Manager (RevMan) [Computer pro-gram]. Version 4.1. Oxford, England: The Cochrane Collaboration, Ison 1998
Ison A, Dillon JR, Tapsall JW. The epidemiology of global antibiotic Deschenes 1990
resistance among Neisseria gonorrhoeae and Haemophilus ducreyi.
Deschenes J, Seamone C, Baines M. The ocular manifestations of The Lancet 1998;351(Supplement):SM8–SM11.
sexually transmitted diseases. Canadian Journal of Ophthalmology
1990;25:177–185.
Wahlberg 1982
Gerbase 1998
Wahlberg V. Reconsideration of Crede prophylaxis. A study of ma- Gerbase AC, Rowley JT, Mertens TE. Global epidemiology of sexu- ternity and neonatal care. Acta Paediatrica Scandinavica 1982;295
ally transmitted diseases. The Lancet 1998;351(Supplement):SM2–
∗ Indicates the major publication for the study Interventions for preventing ophthalmia neonatorum (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
A P P E N D I C E S
Appendix 1. CENTRAL search strategy
#1 GONORRHEA*:ME#2 NEISSERIA-GONORRHOEAE*:ME#3 GONORR*#4 ((#1 or #2) or #3)#5 CHLAMYDIA*:ME#6 CHLAMYDIA-INFECTIONS*:ME#7 CHLAMYD*#8 ((#5 or #6) or #7)#9 EYE-INFECTIONS*:ME#10 CONJUNCTIVITIS*:ME#11 (#9 or #10)#12 ((#4 or #8) or #11)#13 INFANT-NEWBORN*:ME#14 ((((#13 or INFANT*) or NEWBORN*) or NEW-BORN*) or NEONATE*)#15 (#12 and #14)#16 OPHTHALMIA-NEONATORUM*:ME#17 (OPHTHALMIA and NEONATORUM)#18 (#16 or #17)#19 (#15 or #18) Appendix 2. MEDLINE search strategy
#1 explode “GONORRHEA”/ all subheadings#2 “NEISSERIA-GONORRHOEAE”/ all subheadings#3 GONORR*#4 #1 or #2 or #3#5 “CHLAMYDIA”/ all subheadings#6 “CHLAMYDIA-TRACHOMATIS”/ all subheadings#7 CHLAMYD*#8 #5 or #6 or #7#9 ’OPHTHALMIA NEONATORUM’#10 explode “CONJUNCTIVITIS,-BACTERIAL”/ all subheadings#11 #4 or #8 or #9 or #10#12 explode “INFANT,-NEWBORN”/ all subheadings#13 INFANT* or NEW?BORN* or NEO?NAT*#14 #12 or #13#15 #11 and #14This strategy will be combined with the Cochrane Highly Sensitive Search Strategy as described in the Cochrane Reviewer’s Handbook().
Interventions for preventing ophthalmia neonatorum (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
W H A T ’ S N E W
D E C L A R A T I O N S O F I N T E R E S T
Vimal Kapoor is being funded by a Pharmaceutical Manufacturers’ Association of Canada/IWK-Grace Studentship for this systematicreview. However, no one involved with this review has any financial links with Pharmaceutical Manufacturers’ Association of Canada.
S O U R C E S O F S U P P O R T
Internal sources
• Pharmaceutical Manufacturers’ Association of Canada / IWK-Grace Studentship, Canada.
External sources
Interventions for preventing ophthalmia neonatorum (Protocol)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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