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Prophylaxis of Ophthalmia neonatorum - A nationwide survey of the current

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'. 38.043-

I Original Article I wie n e r kli11i sc 11 e

wo c hen s c h ri f t
the middle european journal
of medicine
Wien Klin Wochenschr (2002) 114/5-6: 194-199
Printed in Austria
0 Springer-Verlag 2002

Prophylaxis of Ophthalmia neonatorum - A nationwide survey

of the current practice in Austria
Ojan Assadian', Afshin Assadian', Christoph Aspöck', Daniela Hahn', and Walter Koller'
I Division of Hospital Hygiene. Institute of Hygiene of the University of Vienna Medical School, and
* Department of Gynaecology & Obstetrics, Wilhelminenspital, Vienna. Austria

Prophylaxe der Ophthalmia neonatorum Spektrum - substances were Tetracycline, Povidone-lodine, Neomy-
der eingesetzten Substanzen und aktuelle
Handhabung in Österreich
Zusammenfassung. Hintergrund: Ziel der österreich-
weit durchgeführten Studie war es, Praxis sowie eingesetz-
te Substanzen zur Prophylaxe der Ophthalmia neonatorum
zu analysieren. Fragebögen wurden an 107 Krankenhäu-
ser und 490 Hebammen verschickt. 91,6% der Kranken-
häuser und 7,6% der Hebammen haben geantwortet.
Ergebnis: Insgesamt kommen in &erreich 7 Sub-
stanzen mit folgender Häufigkeit zur Anwendung: Ery-
thromycin 41,8%; Gentamicin 21,3%; Silbernitrat 19,7%;
Tetracyclin 9%; PVP-Jod 4,9%; Neomycin 2,5%; Chlor-
amphenicol 1 ,l%.
Schlussfolgerung: Wir beobachten ein heterogenes
Spektrum von sieben Substanzen zur Prophylaxe. Da-
runter wurden zwei Antiseptika und fünf Antibiotika an-
gegeben. 71. Y der Anwender setzen dabei Substanzen
ein, die auch in internationalen Empfehlungen für diese
Indikation genannt werden (Erythromycin, Silbernitrat und
Tetracyclin).
83,5% der Krankenhäuser Österreichs wollen ihr der-
zeit eingesetztes Regime nicht ändern, solange es keine phylaxis, neonatal conjunctivitis, antibiotic prophylaxis,
einheitliche österreichweit gültige Richtlinie gibt, obwohl chemical conjunctivitis, bacterial conjunctivitis, question-
43,6% von ihnen regelmäßig eine chemisch induzierte naire, prophylactic agents.
Konjunktivitis bei Neugeborenen beobachten
Schlüsselwörter: Ophthalmia neonatorum, Crede-
sche Prophylaxe, Neugeborenenkonjunktivitis, Antibioti-
kaprophylaxe, chemisch induzierte Konjunktivitis, bakte-
rielle Konjunktivitis, Fragebogenstudie, Prophylaktika.
Summary. The aim of this study was to analyze the
current practice of Ophthalmia neonatorum prophylaxis in
Austria. Questionnaires were sent to 107 hospitals with
obstetric units, as well as to 490 registered community
midwives, together looking after a yearly total of approx-
imately 70,000births. The Overall return of the hospitals
and midwives was 91.6% and 7.6%, respectively.
Results: Ophthalmia neonatorum prophylaxis is be-
ing applied by 93.8% of all respondents (hospitals 96.9%,
and community midwives 82.3%). The three most fre-
quently applied substances were Erythromycin (41.8%),
Gentamicin (21.3%) and Silver nitrate (19.7%). Other
cin and Chloramphenicol. The reported overall-obsewa-
tion of chemical conjunctivitis after application of a pro-
phylactic agent was 42.3% (59133), typically after the
use of Silver nitrate, Erythromycin or Tetracycline. The
agent was determined by pediatricians (29%), in accord-
ance to governmental decree (15%), by hospital policy
(12%), effectiveness against Chlamydia and- Gonococci
(9%), by pharmacists (3%) and ophthalmologists (3%).
18% did not give any reason for the choice of agent.
Conclusion: The rationale for prophylaxis and the
substances used in Austria show heterogeneity. Seven
prophylactic agents are used, two antiseptics and five
antibiotics. 25% of the routine applicants are using sub-
stances (Gentamicin, Neomycin or Chloramphenicol) for
which no evidence based efficacy for prophylaxis of Oph-
thalmia neonatorum has been demonstrated through clin-
ical trials. However, 83.5% of the maternity units do not
Want changes in their current routine, unless there is a
nation-wide agreement for Ophthalmia neonatorum
prophylaxis.
Key words: Ophthalmia neonatorum, Crede's pro-
Introduction
In 1881 the gynecologist Carl Sigmund Franz CredC
(1 8 19-1 892) introduced the use of 2% Silver nitrate solu-
tion as a prophylactic agent against ophthalmia gonor-
rhoica neonatorum. After Observation of frequent eye-
imtations, this was changed to a 1% Silver nitrate solu-
tion. This Change of regimen reduced the yearly incidence
of neonatal conjunctivitis from 13.6% to 0.5% [ I , 21.
Since 1928 Austrian law has regulated the routine use of
Ophthalmia neonatorum prophylaxis. Austrian midwives
have been obliged to execute the prophylaxis in two steps:
First, mechanical cleansing of the eye-lids before the in-
fant Opens them for the first time and second, instillation
of one 1% Silver nitrate drop into each conjunctival sac.
Due to the extended knowledge of other possible patho-
gens such as Chlamydia trachomatis, S taphylococci,
gramnegative bacteria and viruses as well as the avail-
 Assadian et al., Prophylaxis of Ophthalmia neonatorum in Austria 195

ability of different antimicrobial agents, the decree was hospital-questionnaires, only 97 could be evaluated since one
modified in 1970. From then on midwives could either use Hospital had recently closed down the maternity-unit. Three of
1% Silver nitrate or any substance recommended by the the questionnaires sent to community midwives returned with
public health authorities for prophylaxis of Ophthalmia the postal remark “receiver unknown”, one midwife responded
neonatorum. In 1990 Austrian health authorities recom- from Switzerland. where routine application of CredC’s prophy-
mended 1% Silver nitrate Solution, 1% Tetracycline oint- laxis was discontinued ten years ago. Thirty-three of the miid-
ment, 0.5% Oxytetracycline-hydrochloride ointment with wife-questionnaires were evaluated, making a total of 96.3%
Polymyxin-B-Sulfate or 1% Erythromycin ointment for ( 130/135) evaluable questionnaires.
prophylaxis [3]. The last Change in the legal Situation of
Ophthalmia neonatorum prophylaxis took place in 1998. Results
Midwives were now allowed to use prophylactic medica- Routine application of Ophthalmia neonatorum
tion without a doctor’s prescription if the application of prophylaxis in Austria
the substance used was in accordance with good medical Ophthalmia neonatorum prophylaxis is being rdutine-
practice in addition to being recommended by the public ly administered by 96.9% (94197) of responding matemity
health authorities. However, the use of prophylaxis and units and by 84.9% (28133) of responding community
the suitability of prophylactic agents have continued to be midwives. Two hospitals only applied prophylaxis after
challenged during the last decade [MI.The aim of our vaginal births or premature rupture of membranes. In one
’nation-wide survey was to elicit the present Situation and hospital, Ophthalmia neonatorum prophylaxis is only
practice of Ophthalmia neonatorum prophylaxis for the applied after informed consent of the parents regarding
first time after 71 years of use in Austria. Also, we wanted advantages and side effects. Five community midwives
to know which substances were in use, the mode and did not apply any prophylaxis unless the parents explicitly
timing of application and if any desire for an unequivocal wished so.
guideline for the prevention of Ophthalmia neonatorum
exists. Reasons behind the choice of prophylactic agent
Methods In 28.7% (35/122), pediatricians determined the
agent, 14.8% (18/122) were following recommendations
An anonymous questionnaire was sent to 107 hospitals according to previous govemmental decrees, 12.3% (15/
with obstetric units and to all 490 registered community mid-
122) executed hospital policy. Good experience with the
wives in Austria, together looking after a yearly total of ap-
proximately 70,000 births. We inquired about the routine of agent in the past determined the choice in 9.0% (1 11122).
Ophthalmia neonatorum prophylaxis and the agents used, the 4.9% (6/122) Chose the agent because of specific effec-
reason for selecting agents, details about the modalities of tiveness against Chlamydia and gonococci and 4.1% (51
administration and the frequent Observation of complications. 122) claimed effectiveness against Chlamydia infection to
particularly chemical conjunctivitis (e.g. postprophylactic eye explain their decision. Hospital pharmacists determined
irritation). Chemical conjunctivitis was defined as eye dis- the choice in 3.3% (4/122) and ophthalmologists in 2.5%
Charge lasting no longer than 24 hours after application of a (3/122). One answer was illegible, one claimed tradition
prophylactic agent [7]. The total numbers of post prophylactic to be the reason for applying the prophylactic agent and
eye irritations were not enquired. We concentrated on the ques- one argued with hygiene requirements. 18% (221122) of
tion. whether health professionals using Ophthalmia neonato- the respondents gave no reason for the choice of agent.
rum prophylaxis observed adverse effects, and if so. to which
substances. Analysis of the data was performed with SPSS 9.0 Substnnces used for propliylnris of Ophthalrriia
(SPSS Inc., Chicago, 111.). Two-tailed p-values were calculated neonatorum in Austria
by applying Chi-Square test or Fisher’s exact Test, where ap-
propriate. Mantel-Haenszel weighted Odds ratio (OR) together Seven different substances are used by hospitals and
with Comtield 95% Confidence intervals (CI) were computed. community midwives for prophylaxis of Ophthalmia
91.6% (98/107) of the Hospitals and 7.6% (371490) of the neonatorum. Substances and their use are listed in detail in
community midwives retumed the questionnaire. Of the 98 Table 1. Altogether, the three most commonly used sub-

Table 1. Substances used for prophylaxis of Ophthalmia neonatorum in Austria

~~ ~ ~~~ ~~~

Substance * Total Hospitals Community midwives OR 958CI P

n % n % n %

Eryt hromyci n 51 41.8 38 40.4 13 46.4 0.78 0.3 1-2.01 0.57

Gentamicin 26 21.3 20 21.3 6 21.4 . 0.99 0.33-3.40 0.99
Silver nitrate 24 19.7 23 24.5 1 3.6 8.75 1.27-373.42 0.015*
Tetracycline I1 9.0 6 6.4 5 17.9 ’ 0.31 0.07-1.44 0.12
Povidone-Iodine 6 4.9 4 4.3 2 7.1 0.58 0.08-6.76 0.62
Neomycin 3 2.5 2 2.1 1 3.6 0.59 0.03-35.90 0.55
Chloramphenicol 1 0.8 1 1.1 0 0.0 - - 1.oo
 196 Assadian et al., Prophylaxis of Ophthalmia neonatorum in Austria

stances for Ophthalmia neonatorum proph'ylaxis in Austria Desire for charige of the current practice:
are Erythromycin (41.8%; 51/122), Gentamicin (21.3%; (only hospitals with rorrtine application included)
?6/122) and Silver nitrate ( 1 9.7%; 24/122). Hospitals 43.6% (41194) of hospitals stated, that they do not
used, in decreasing Order, Erythromycin, Silver nitrate and wish to Change their current practice, unless unequivocal
Gentamicin, whereas community midwives used Erythro- nation-wide guidelines are released.
mycin, Gentamicin and Tetracycline.
Discussion
Observation of cheriiical conjunctivitis @er the Even after 115 years of use, Ophthalmia neonatorum
roirtine application of prophylactic cigents prophylaxis is not obsolete and an important issue in
43.6% (41/94) of the hospitals reported frequent ob- maintaining public health. Countries having discontinued
servation of chemical conjunctivitis after the instillation the practice of Ophthalmia neonatorum prophylaxis like
of prophylactic agents as did fifty percent (14/28) of the Sweden and Denmark experience a rise in the incidence of
community midwives. Details are shown in Table 2. Ophthalmia neonatorum due to gonococci [8, 91. Interest-
Chemical conjunctivitis was observed most frequently ingly, although prophylaxis is not administered routinely
with Silver nitrate (OR 4.95, 95% CI 1.67-16.42, in the UK a decreasing incidence of Ophthalmia neonato-
p = 0.001), whereas Gentamicin was the best-tolerated rum has been reported. On the other hand, in the USA and
substance (0.22, 95%CI 0.06-0.66, p = 0.003). Canada a rise in the incidence of Ophthalmia neonatorum
bas been observed, even though the respective health
authorities recommend prophylaxis of Ophthalmia neona-
Timing and mode of application of prophylaxis torum. Austrian authorities believe in prophylaxis, since
Asked about the timing of prophylaxis, 55.4% (72 prevention, especially in pediatric patients, is preferable to
130) answered that application occurs within 1 to 30 treatment of a manifest disease. The German-Austrian
minutes after birth (64 Hospitals and 8 community mid- Society for Perinatal Medicine also recommends the fur-
wives). 40.88 (53/130) stated that prophylaxis is applied ther use of Ophthalmia neonatorum prophylaxis [ 101.
between 30 minutes and 2 hours post partum (32 hospitals The onset of Ophthalmia neonatorum Symptoms usu-
and 21 community midwives). One hospital and 4 mid- ally develops days after discharge from hospital. It de-
wives (3.8%; 9130) did not comment on this question. pends on the causative pathogen and ranges from 2 up to
73.1 % (95430) stated that medication is simply instilled 14 days post partum. Conjunctivitis presenting after 2 to 4
(72 hospitals and 23 community midwife). 23.1% (301 days post partum is usually due to an infection caused by
130) reported that they first cleaned the eyes of the new- Neisseria gonorrhoeae, after 5 to 7 days due to Herpes
bom mechanically (24 hospitals and 6 community mid- Simplex Virus and after 5 up to 14 days due to Chfamydia
wives). 3.8% (5/130) used other modes of application trachomatis [ 11).
(1 hospital and 4 community midwives) without any fur- The most severe form of Ophthalmia neonatorum is
ther specification. caused by Neisseria gonorrhoeae. It may result in blind-

Table 2. Observation of chemical conjunctivitis (CC) according to substance. stratified by hospitals and comrnunity midwives

Hospitals Community midwives

CCpos. CC neg. OR 95%CI P CC POS. CC neg. OR 95%CI P
Erythromycin 18 20 1.29 0.69-2.41 0.55 7 6 1.33 0.24-7.56 0.14
Gentamicin 3 17 0.17 0.03-0.66 0.004* 2 4 0.42 0.03-3.73 0.36
Silver nitrate 17 6 5.55 1.76-19.15 0.0008* 1 0 - - 1.oo
Tetracycline 2 4 0.63 0.054.67 0.63 2 3 0.61 0.046.54 1.00
PVP-Iodine 1 3 0.42 0.001-5.46 0.69 1 1 1.00 0.01-84.46 1.00
Neomycin 0 1 0.00 0.00-50.41 1.00 1 ' 0 - - 1.00
Chloramph. 0 1 0.00 0.00-50.41 1.00 0 0 - - I .oo
* Total
~~ ~~~

CCpos. CC neg. OR 958CI P

Erythromycin 25 26 1.33 0.60-2.88 0.46
Gentamicin 5 11 0.22 0.06-0.66 0.003*
Silver nitrate 18 6 4.95 1.67-16.42 0.001*
Tetracycline 4 7 0.67 0.14-2.83 0.75
PVP-Iodine 2 4 0.59 0.05-4.35 0.69
Neom ycin 1 2 0.60 0.01-1 1.90 1 .OO
Chloramph. 0 1 0.00 0.00-47.51 1.00

* Significant difference in Observation of chemicd conjunctivitis

 Assadian et al., Prophylaxis of Ophthalmia neonatorum in Austria
ness by penetration of the Cornea in a very short time.
Gonococcal Ophthalmia neonatorum has a dramatic clin-
ical presentation, though it is a treatable condition when
diagnosed promptly. Presently, the incidence of gonococ-
cal infections is falling in many industrialized countries.
Nevertheless, an increase of non-gonococcal Ophthalmia
neonatorum can be observed with an incidence of up to
22% in industrial countries [12].
According to the Centers for Disease Control and
Prevention, the most commonly isolated pathogen causing
Ophthalmia neonatorum is Chlamydia trnchomatis. It in-
duces a symptomatic conjunctivitis after five to fourteen
days post partum. At that time, most newboms and their
mothers are already discharged from hospital care and are
no longer under close medical Observation. Chlarnydia
trachomatis may impair Vision as a result of comeal and
conjunctival scaring, vascularisation [ 131 and formation
. of pseudo-membranes [ 14). However, this complication
results only, if the Patient is frequently re-infected [15-
171, which usually does not occur in industrialized coun-
tries. Therefore, this clinical presentation is most com-
monly Seen in developing countries. Without recurrent
infections with Chlarnydia trachomatis, the Symptoms
subside within one to three weeks, making chlamydial
Ophthalmia neonatorum a usually self-limiting infection.
Other pathogens, less frequently causing Ophthalmia
neonatorum are Staphylococci, S treptococci, Pseudomon-
ades, other gram-negative organisms and Herpes viruses.
The latter are not as frequently observed as are gonococci
or chlamydia, and most of them do not lead to severe
complications.
Properties of an ideal substance for Ophthalrnia
neonatorum prophylaxis
The ideal substance for Ophthalmia neonatorum
prophylaxis should be active against all relevant bacterial
and viral pathogens. To avoid a decrease of bonding in the
first days of life, it should not induce chemical conjuncti-
vitis. Additionally, the substance should be inexpensive.
Bacterial contamination of eye drop bottles ranges from
12.98 to 27% [18, 191, showing signifrcant differences
between in-hospital and outpatient use. Hence, to avoid
potential Cross-infections by contaminated eye drop bot-
tles or ointment vehicle [20], disposable Containers should
be used.
International guidelines and recommended
Substances
Our study revealed a variety of substances and prac-
tices used for prophylaxis against Ophthalmia neonatorum
in Austria. In 1990, Austrian health authorities recom-
mended the use of Silver nitrate, Erythromycin, Tetra-
cycline or Oxytetracycline-hydrochlorid ointment in com-
bination with Polymyxin-B-Sulfate for the mandatory
prophylaxis against Ophthalmia neonatorum. In 1998, the
CDC recommended the use of Silver nitrate, Erythro-
mycin or Tetracycline [2 11. Other substances mentioned
as prophylactic agents wem Bacitracin and Povidone-
Iodine. The Canadian STD Guidelines of 1992 [22] did
recommend the use of Silver nitrate, Erythromycin or
Tetracycline. In the 1998 Canadian STD Guidelines [23],
197
other pathogens causing Ophthalmia neonatorum like
Herpes Simplex Virus and Staphylococcus aureus were
mentioned. In these guidelines it was stated, that none of
the above substances Cover the whole spectrum of possible
causat ive pat hogens.
In the UK, the North Thames (East) Regional Audit
does not recommend the use of prophylaxis against Oph-
thalmia neonatorum, and no prophylaxis is suggested be-
cause of the following reasons: ocular prophylaxis with
Silver nitrate, Erythromycin or Tetracycline eye ointment
mask parental infection. Extra-ocular sites are not treated
and prophylactic substances are not necessarily effective
in preventing both 'gonococcal and chlamydial Ophthal-
mia neonatorum [24]. Furthermore, facilities for early
diagnosis and management are available.
*
The foundation of the above guidelines is the fact,
that Ophthalmia neonatorum is still a health issue. How-
ever, there has been a shift in the spectrum of the causa-
tive pathogens. As the CDC and the Canadian STD Guide-
lines explicitly mention, the prevalence of chlamydial
infection is on the rise, whereas the numbers of gonococ-
cal infections are falling. However, Silver nitrate is highly
active against Neisseria gonorrhoeae but much less effec-
tive against Chlamydia trachomatis and viruses [25-271.
It is also the substance with the highest potential for
chemical conjunctivitis. In our survey, 75% of the re-
spondents using Silver nitrate observed chemical conjunc-
tivitis. If not applied in single use Containers, the solvent
will evaporate with time increasing the concentration of
Silver nitrate. This will lead to higher numbers of eye
imtations. To our knowledge, there are no reports of
resistance of Neisseria gonorrhoeae to Silver nitrate. Tet-
racycline is active against Neisseria gonorrhoeae and
Chlaniydia trachomntis. It also Covers Streptococci,
Haemophilus influenzae, Pseudomonas spp. and Staphylo-
cocci. However, resistances are reported [28-301, making
this substance no longer a suitable first line agent for the
empirical prevention of Ophthalmia neonatorum. 36% of
the respondents using Tetracycline observed chemical
conjunctivitis. Erythromycin is highly potent against
Chlamydia trachomatis, but less effective against gono-
cocci than Tetracycline or Silver nitrate. In our survey, it
was reported to less frequently cause chemical conjuncti-
vitis (49% vs. 75%) than Silver nitrate but more frequent-
ly than Tetracycline (49% vs. 36%). It is expensive and
ineffective against viruses. Finally, the use of antimicrobi-
al substances like Erythromycin and Tetracycline cannot
prevent conjunctival infection with pathogens resistant to
these substances [31, 321. Each of the above named sub-
stances fulfill only some aspects of the desired Profile for
an ideal agent for prophylaxis against Ophthalmia neo-
natorum and no single topical agent is effective to ideally
prevent ocular complications of both Neisseria gonor-
rhoeae and Chlaniydia trachomatis.
Even though only briefly mentioned in the CDC
Guideline, Povidone-Iodine has advantages compared to
Erythromycin, Tetracycline and Silver nitrate. It has a
broader antimicrobial espectrum as well as effectiveness
against viruses including herpes Simplex Virus 11 [331.
Besides its antibacterial and antiviral capacity, there are
no reports of resistance, which is explained by the chem-
ical mechanism of action due to oxidizing effects of free
 198 Assadian et al.. Prophylaxis of Ophthalmia neonatorum in Ausiria

iodine on functional groups of amino acids, nucleotides HO, et al (1 988) Prophylaxis of gonococcal and chlamy-
and the double bonds of unsaturated fatty acids (341. dial Ophthalmia neonatorum. A comparison of Silver ni-
Additionally, it turns the surface of the eye brown for a trate and Tetracycline. N Engl J Med 3 18/11 : 653-657
few minutes. This feature can be used as a control of 7. Nishida H, Risemberg HLM (1975) Silver nitrate ophthal-
proper application into the eye of the newbom. mic solution and chem'ical conjunctivitis. Pediatrics 56/3:
Good clinical results were published with Povidone- 368-373
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of concentrations still needs to be evaluated in further I (1991) Neonatal conjunctivitis after the abolition of com-
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gists, ophthalmologists and clinical microbiologists was Schnittes. In: Lund OE, Waubke TN (Hrsg) Früherkennung
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.1.2. Bell TA, Grayton JT, Krohn MA, Krnmal RA (1993) Eye
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(Received August 20, 2001, accepted after revision October 17, 2001)
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Dermatology (accepted for publication)
36. Oberster Sanitätsrat im Bundesministerium für soiiale Si-
cherheit und Gesundheit, 4. Vollversammlung am 18. No-
'
vember 2000
Correspondence: Ojan Assadian, M.D., DTM & H, Insti-
tute of Hygiene of the University of Vienna Medical School,
Division of Hospital Hygiene, University Hospital Vienna,
Währinger Gürtel 18-20, A- 1090 Vienna, Austria,
Email: ojan.assadian@akh-wien.ac.at

I,
i
 LITERATURSERVICE
Betaisodona@Nr.: 3

Quelle:
Wiener Klinische Wochenschrift (2002) 114/5-6:171-172 - Editorial: Prof. Dr. Axel Kramer,
Institut für Hygiene und Umweltmedizin, Ernst-Moritz-Arndt Universität Greifswald
Wiener Klinische Wochenschrift (2002) 114/5-6:194-1999- Original Article: Ojan
Assadian, Afshin Assadian, Christoph Aspöck, Daniela Hahn und Walter Koller;
Hygieneinstitut Wien, Gynäkologische Abteilung Wilhelminenspital Wien.

Neue Aspekte zur Prophylaxe der Ophtalmia

neonatorum (Crede prophylaxis)
Nach derzeitigem Stand der Wissenschaft ist PVP-Jod 1,25% als isoosmolarische
Lösung das Antiseptikum der Wahl für die Credesche Prophylaxe. PVP-Jod ist die
beste Alternative zu Silbernitrat, weil es ein breites Keimspektrum abdeckt und
besser verträglich ist.

Empfohlene Rezeptur:
- Povidone iodine
(Low molecular with a K-value of 4 8 ) 0.125 g
- sodium Chloride 0.08 g
- disodium hydrogen Phosphate X 12 H200.025 g
- water for injection ad 10 g

H:\Literaturverservice\BetaisodonaLiteratwBeta-03 CredCsche Prophylaxe.doc

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