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Meta-Analysis
. 2020 Sep 21;9(9):CD001862.
doi: 10.1002/14651858.CD001862.pub4.

Interventions for preventing ophthalmia neonatorum

Vimal Scott Kapoor  1 , Jennifer R Evans  2 , S Swaroop Vedula  3
Affiliations
Meta-Analysis

Interventions for preventing ophthalmia neonatorum

Vimal Scott Kapoor et al. Cochrane Database Syst Rev. .

Abstract

Background: Ophthalmia neonatorum is an infection of the eyes in newborns that can lead to blindness, particularly if the infection is caused by Neisseria gonorrhoeae. Antiseptic or antibiotic medication is dispensed into the eyes of newborns, or dispensed systemically, soon after delivery to prevent neonatal conjunctivitis and potential vision impairment.

Objectives: 1. To determine if any type of systemic or topical eye medication is better than placebo or no prophylaxis in preventing ophthalmia neonatorum. 2. To determine if any one systemic or topical eye medication is better than any other medication in preventing ophthalmia neonatorum.

Search methods: We searched CENTRAL, MEDLINE, Embase, LILACS, and three trials registers, date of last search 4 October 2019. We also searched references of included studies and contacted pharmaceutical companies. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials of any topical, systemic, or combination medical interventions used to prevent ophthalmia neonatorum in newborns compared with placebo, no prophylaxis, or with each other.

Data collection and analysis: We used standard methods expected by Cochrane. Outcomes were: blindness or any adverse visual outcome at 12 months, conjunctivitis at 1 month (gonococcal (GC), chlamydial (CC), bacterial (BC), any aetiology (ACAE), or unknown aetiology (CUE)), and adverse effects. MAIN RESULTS: We included 30 trials with a total of 79,198 neonates. Eighteen studies were conducted in high-income settings (the USA, Europe, Israel, Canada), and 12 were conducted in low- and middle-income settings (Africa, Iran, China, Indonesia, Mexico). Fifteen of the 30 studies were quasi-randomised. We judged every study to be at high risk of bias in at least one domain. Ten studies included a comparison arm with no prophylaxis. There were 14 different prophylactic regimens and 12 different medications in the 30 included studies. Any prophylaxis compared to no prophylaxis Unless otherwise indicated, the following evidence comes from studies assessing one or more of the following interventions: tetracycline 1%, erythromycin 0.5%, povidone-iodine 2.5%, silver nitrate 1%. None of the studies reported data on the primary outcomes: blindness or any adverse visual outcome at any time point. There was only very low-certainty evidence on the risk of GC with prophylaxis (4/5340 newborns) compared to no prophylaxis (5/2889) at one month (risk ratio (RR) 0.79, 95% confidence interval (CI) 0.24 to 2.65, 3 studies). Low-certainty evidence suggested there may be little or no difference in effect on CC (RR 0.96, 95% CI 0.57 to 1.61, 4874 newborns, 2 studies) and BC (RR 0.84, 95% CI 0.37 to 1.93, 3685 newborns, 2 studies). Moderate-certainty evidence suggested a probable reduction in risk of ACAE at one month (RR 0.65, 95% 0.54 to 0.78, 9666 newborns, 8 studies assessing tetracycline 1%, erythromycin 0.5%, povidone-iodine 2.5%, silver nitrate 1%, colostrum, bacitracin-phenacaine ointment). There was only very low-certainty evidence on CUE (RR 1.75, 95% CI 0.37 to 8.28, 330 newborns, 1 study). Very low-certainty evidence on adverse effects suggested no increased nasolacrimal duct obstruction (RR 0.93, 95% CI 0.68 to 1.28, 404 newborns, 1 study of erythromycin 0.5% and silver nitrate 1%) and no increased keratitis (single study of 40 newborns assessing silver nitrate 1% with no events). Any prophylaxis compared to another prophylaxis Overall, evidence comparing different interventions did not suggest any consistently superior intervention. However, most of this evidence was of low-certainty and was extremely limited.

Authors' conclusions: There are no data on whether prophylaxis for ophthalmia neonatorum prevents serious outcomes such as blindness or any adverse visual outcome. Moderate-certainty evidence suggests that the use of prophylaxis may lead to a reduction in the incidence of ACAE in newborns but the evidence for effect on GC, CC or BC was less certain. Comparison of individual interventions did not suggest any consistently superior intervention, but data were limited. A trial comparing tetracycline, povidone-iodine (single administration), and chloramphenicol for GC and CC could potentially provide the community with an effective, universally applicable prophylaxis against ophthalmia neonatorum.

PubMed Disclaimer

Conflict of interest statement

VK was funded by a three‐month Pharmaceutical Manufacturers' Association of Canada/IWK‐Grace Scholarship for part of the time spent on this systematic review. However, neither Dr Kapoor nor anyone else involved with this review has ever had any financial links with the Pharmaceutical Manufacturers' Association of Canada. JE has no known interests to declare. SSV's earlier effort on this review was supported by the Cochrane Eyes and Vision Group US Project with funding through Contract N‐01‐EY‐2‐1003 with the National Eye Institute, National Institutes of Health, USA. The Cochrane Eyes and Vision Group US Project is now supported by co‐operative agreement 1 U01 EY020522, National Eye Institute, National Institutes of Health, USA.

Figures

1
1
PRISMA flow diagram
2
2
Table of Trial Settings
3
3
Table of Trials, Interventions, Method of Allocation, Settings
4
4
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
5
5
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
6
6
Forest plot of comparison: 1 Any prophylaxis versus no prophylaxis, outcome: 1.1 Gonococcal conjunctivitis
7
7
Forest plot of comparison: 8 Erythromycin versus silver nitrate, outcome: 8.1 Gonococcal conjunctivitis.
8
8
Forest plot of comparison: 8 Erythromycin versus silver nitrate, outcome: 8.2 Chlamydial conjunctivitis.
9
9
Forest plot of comparison: 9 Tetracycline versus silver nitrate, outcome: 9.1 Gonococcal conjunctivitis.
10
10
Forest plot of comparison: 9 Tetracycline versus silver nitrate, outcome: 9.2 Chlamydia conjunctivitis.
11
11
Forest plot of comparison: 9 Tetracycline versus silver nitrate, outcome: 9.3 Any conjunctivitis of any aetiology
12
12
Forest plot of comparison: 17 Povidone‐iodine versus erythromycin, outcome: 17.1 Gonococcal conjunctivitis
13
13
Prophylaxis of GC
14
14
Prophylaxis of CC
15
15
Prophylaxis of BC
16
16
Prophylaxis of ACAE
17
17
Prophylaxis of CUE
1.1
1.1. Analysis
Comparison 1: Any prophylaxis versus no prophylaxis, Outcome 1: Chlamydial conjunctivitis
1.2
1.2. Analysis
Comparison 1: Any prophylaxis versus no prophylaxis, Outcome 2: Bacterial conjunctivitis
1.3
1.3. Analysis
Comparison 1: Any prophylaxis versus no prophylaxis, Outcome 3: Any conjunctivitis of any aetiology
1.4
1.4. Analysis
Comparison 1: Any prophylaxis versus no prophylaxis, Outcome 4: Conjunctivitis of unknown aetiology
1.5
1.5. Analysis
Comparison 1: Any prophylaxis versus no prophylaxis, Outcome 5: Nasolacrimal duct obstruction
1.6
1.6. Analysis
Comparison 1: Any prophylaxis versus no prophylaxis, Outcome 6: Keratitis
2.1
2.1. Analysis
Comparison 2: Silver nitrate versus no prophylaxis, Outcome 1: Gonococcal conjunctivitis
2.2
2.2. Analysis
Comparison 2: Silver nitrate versus no prophylaxis, Outcome 2: Chlamydial conjunctivitis
2.3
2.3. Analysis
Comparison 2: Silver nitrate versus no prophylaxis, Outcome 3: Any conjunctivitis of any aetiology
2.4
2.4. Analysis
Comparison 2: Silver nitrate versus no prophylaxis, Outcome 4: Corneal abrasion
2.5
2.5. Analysis
Comparison 2: Silver nitrate versus no prophylaxis, Outcome 5: Nasolacrimal duct obstruction
3.1
3.1. Analysis
Comparison 3: Erythromycin versus no prophylaxis, Outcome 1: Gonococcal conjunctivitis
3.2
3.2. Analysis
Comparison 3: Erythromycin versus no prophylaxis, Outcome 2: Chlamydial conjunctivitis
3.3
3.3. Analysis
Comparison 3: Erythromycin versus no prophylaxis, Outcome 3: Bacterial conjunctivitis
3.4
3.4. Analysis
Comparison 3: Erythromycin versus no prophylaxis, Outcome 4: Any conjunctivitis of any aetiology
3.5
3.5. Analysis
Comparison 3: Erythromycin versus no prophylaxis, Outcome 5: Conjunctivitis of unknown aetiology
3.6
3.6. Analysis
Comparison 3: Erythromycin versus no prophylaxis, Outcome 6: Nasolacrimal duct obstruction
4.1
4.1. Analysis
Comparison 4: Tetracycline versus no prophylaxis, Outcome 1: Gonococcal conjunctivitis
4.2
4.2. Analysis
Comparison 4: Tetracycline versus no prophylaxis, Outcome 2: Chlamydial conjunctivitis
4.3
4.3. Analysis
Comparison 4: Tetracycline versus no prophylaxis, Outcome 3: Any conjunctivitis of any aetiology
5.1
5.1. Analysis
Comparison 5: Povidone‐iodine versus no prophylaxis, Outcome 1: Gonococcal conjunctivitis
5.2
5.2. Analysis
Comparison 5: Povidone‐iodine versus no prophylaxis, Outcome 2: Chlamydial conjunctivitis
5.3
5.3. Analysis
Comparison 5: Povidone‐iodine versus no prophylaxis, Outcome 3: Bacterial conjunctivitis
5.4
5.4. Analysis
Comparison 5: Povidone‐iodine versus no prophylaxis, Outcome 4: Any conjunctivitis of any aetiology
5.5
5.5. Analysis
Comparison 5: Povidone‐iodine versus no prophylaxis, Outcome 5: Conjunctivitis of unknown aetiology
6.1
6.1. Analysis
Comparison 6: Bacitracin‐phenacaine versus no prophylaxis, Outcome 1: Gonococcal conjunctivitis
7.1
7.1. Analysis
Comparison 7: Colostrum versus no prophylaxis, Outcome 1: Any conjunctivitis of any aetiology
8.1
8.1. Analysis
Comparison 8: Erythromycin versus silver nitrate, Outcome 1: Chlamydial conjunctivitis
8.2
8.2. Analysis
Comparison 8: Erythromycin versus silver nitrate, Outcome 2: Bacterial conjunctivitis
8.3
8.3. Analysis
Comparison 8: Erythromycin versus silver nitrate, Outcome 3: Any conjunctivitis of any aetiology
8.4
8.4. Analysis
Comparison 8: Erythromycin versus silver nitrate, Outcome 4: Conjunctivitis of unknown aetiology
8.5
8.5. Analysis
Comparison 8: Erythromycin versus silver nitrate, Outcome 5: Nasolacrimal duct obstruction
9.1
9.1. Analysis
Comparison 9: Tetracycline versus silver nitrate, Outcome 1: Chlamydial conjunctivitis
9.2
9.2. Analysis
Comparison 9: Tetracycline versus silver nitrate, Outcome 2: Nasolacrimal duct obstruction
10.1
10.1. Analysis
Comparison 10: Sulfacetamide versus silver nitrate, Outcome 1: Gonococcal conjunctivitis
10.2
10.2. Analysis
Comparison 10: Sulfacetamide versus silver nitrate, Outcome 2: Bacterial conjunctivitis
10.3
10.3. Analysis
Comparison 10: Sulfacetamide versus silver nitrate, Outcome 3: Any conjunctivitis of any aetiology
10.4
10.4. Analysis
Comparison 10: Sulfacetamide versus silver nitrate, Outcome 4: Conjunctivitis of unknown aetiology
11.1
11.1. Analysis
Comparison 11: Cetyl‐pyridinium chloride versus silver nitrate, Outcome 1: Bacterial conjunctivitis
11.2
11.2. Analysis
Comparison 11: Cetyl‐pyridinium chloride versus silver nitrate, Outcome 2: Any conjunctivitis of any aetiology
11.3
11.3. Analysis
Comparison 11: Cetyl‐pyridinium chloride versus silver nitrate, Outcome 3: Conjunctivitis of unknown aetiology
12.1
12.1. Analysis
Comparison 12: Penicillin versus silver nitrate, Outcome 1: Gonococcal conjunctivitis
12.2
12.2. Analysis
Comparison 12: Penicillin versus silver nitrate, Outcome 2: Bacterial conjunctivitis
12.3
12.3. Analysis
Comparison 12: Penicillin versus silver nitrate, Outcome 3: Any conjunctivitis of any aetiology
12.4
12.4. Analysis
Comparison 12: Penicillin versus silver nitrate, Outcome 4: Conjunctivitis of unknown aetiology
13.1
13.1. Analysis
Comparison 13: Penicillin IM versus silver nitrate, Outcome 1: Gonococcal conjunctivitis
13.2
13.2. Analysis
Comparison 13: Penicillin IM versus silver nitrate, Outcome 2: Bacterial conjunctivitis
13.3
13.3. Analysis
Comparison 13: Penicillin IM versus silver nitrate, Outcome 3: Any conjunctivitis of any aetiology
13.4
13.4. Analysis
Comparison 13: Penicillin IM versus silver nitrate, Outcome 4: Conjunctivitis of unknown aetiology
14.1
14.1. Analysis
Comparison 14: Povidone‐iodine versus silver nitrate, Outcome 1: Gonococcal conjunctivitis
14.2
14.2. Analysis
Comparison 14: Povidone‐iodine versus silver nitrate, Outcome 2: Chlamydial conjunctivitis
14.3
14.3. Analysis
Comparison 14: Povidone‐iodine versus silver nitrate, Outcome 3: Bacterial conjunctivitis
14.4
14.4. Analysis
Comparison 14: Povidone‐iodine versus silver nitrate, Outcome 4: Any conjunctivitis of any aetiology
14.5
14.5. Analysis
Comparison 14: Povidone‐iodine versus silver nitrate, Outcome 5: Conjunctivitis of unknown aetiology
15.1
15.1. Analysis
Comparison 15: Tetracycline versus erythromycin, Outcome 1: Chlamydial conjunctivitis
15.2
15.2. Analysis
Comparison 15: Tetracycline versus erythromycin, Outcome 2: Any conjunctivitis of any aetiology
16.1
16.1. Analysis
Comparison 16: Colostrum versus erythromycin, Outcome 1: Any conjunctivitis of any aetiology
17.1
17.1. Analysis
Comparison 17: Povidone‐iodine versus erythromycin, Outcome 1: Chlamydial conjunctivitis
17.2
17.2. Analysis
Comparison 17: Povidone‐iodine versus erythromycin, Outcome 2: Bacterial conjunctivitis
17.3
17.3. Analysis
Comparison 17: Povidone‐iodine versus erythromycin, Outcome 3: Any conjunctivitis of any aetiology
17.4
17.4. Analysis
Comparison 17: Povidone‐iodine versus erythromycin, Outcome 4: Conjunctivitis of unknown aetiology
18.1
18.1. Analysis
Comparison 18: Pencillin IM versus tetracycline, Outcome 1: Gonococcal conjunctivitis
18.2
18.2. Analysis
Comparison 18: Pencillin IM versus tetracycline, Outcome 2: Chlamydial conjunctivitis
19.1
19.1. Analysis
Comparison 19: Povidone‐iodine versus tetracycline, Outcome 1: Gonococcal conjunctivitis
19.2
19.2. Analysis
Comparison 19: Povidone‐iodine versus tetracycline, Outcome 2: Chlamydial conjunctivitis
19.3
19.3. Analysis
Comparison 19: Povidone‐iodine versus tetracycline, Outcome 3: Bacterial conjunctivitis
19.4
19.4. Analysis
Comparison 19: Povidone‐iodine versus tetracycline, Outcome 4: Any conjunctivitis of any aetiology
19.5
19.5. Analysis
Comparison 19: Povidone‐iodine versus tetracycline, Outcome 5: Conjunctivitis of unknown aetiology
20.1
20.1. Analysis
Comparison 20: Povidone‐iodine versus chloramphenicol, Outcome 1: Gonococcal conjunctivitis
20.2
20.2. Analysis
Comparison 20: Povidone‐iodine versus chloramphenicol, Outcome 2: Chlamydial conjunctivitis
21.1
21.1. Analysis
Comparison 21: Povidone‐iodine versus carbethopendecinium bromide, Outcome 1: Any conjunctivitis of any aetiology
22.1
22.1. Analysis
Comparison 22: Povidone‐iodine twice versus povidone‐iodine once, Outcome 1: Gonococcal conjunctivitis
22.2
22.2. Analysis
Comparison 22: Povidone‐iodine twice versus povidone‐iodine once, Outcome 2: Chlamydial conjunctivitis
22.3
22.3. Analysis
Comparison 22: Povidone‐iodine twice versus povidone‐iodine once, Outcome 3: Bacterial conjunctivitis
22.4
22.4. Analysis
Comparison 22: Povidone‐iodine twice versus povidone‐iodine once, Outcome 4: Any conjunctivitis of any aetiology
22.5
22.5. Analysis
Comparison 22: Povidone‐iodine twice versus povidone‐iodine once, Outcome 5: Conjunctivitis of unknown aetiology
23.1
23.1. Analysis
Comparison 23: Penicillin IM versus topical penicillin, Outcome 1: Gonococcal conjunctivitis
23.2
23.2. Analysis
Comparison 23: Penicillin IM versus topical penicillin, Outcome 2: Bacterial conjunctivitis
23.3
23.3. Analysis
Comparison 23: Penicillin IM versus topical penicillin, Outcome 3: Any conjunctivitis of any aetiology
23.4
23.4. Analysis
Comparison 23: Penicillin IM versus topical penicillin, Outcome 4: Conjunctivitis of unknown aetiology
See this image and copyright information in PMC

Comment in

References

References to studies included in this review

Ali 2007 {published data only}
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Chen 1992 {published data only}
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Christian 1960 {published data only}
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Cousineau 1952 {published data only}
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David 2011 {published data only}
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Davidson 1951 {published data only}
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Fischer 1988 {published data only}
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Ghaemi 2014 {published data only}
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Ghahramani 2007 {published data only}
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Ghotbi 2012 {published data only}
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Graf 1994 {published data only}
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Harris 1957 {published data only}
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Hick 1985 {published data only}
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Isenberg 2003 {published data only}
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Ramirez‐Ortiz 2007 {published data only}
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References to studies excluded from this review

Assadian 2002 {published data only}
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Bailey 1993 {published data only}
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Baptista 1968 {published data only}
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Baveja 1997 {published data only}
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Bobo 1997 {published data only}
    1. Bobo LD, Novak N, Munoz B, Hsieh YH, Quinn TC, West S. Severe disease in children with trachoma is associated with persistent Chlamydia trachomatis infection. Journal of Infectious Disease 1997;176(6):1524-30. - PubMed
Brady 1997 {published data only}
    1. Brady RC. Index of suspicion. Case 2. Diagnosis: gonorrhea conjunctivitis. Pediatrics in Review 1997;18(5):175-7. - PubMed
Burr 2017 {published data only}
    1. Burr SE, Camara B, Oluwalana C, Bojang E, Bottomley C, Bojang A, et al. Does azithromycin given to women in labour decrease ocular bacterial infection in neonates? A double-blind, randomized trial. BMC Infectious Diseases 2017;17(1):799. - PMC - PubMed
Candano 1951 {published data only}
    1. Candano A, Avila Cisneros I. Prophylaxis against ophthalmia neonatorum. Penicillin as a substitute for Crede's method [Profilaxis de la oftalmia neonatorum. Utilizacion de la penicilina en substitucion del metodo Crede]. Boletin de la Sociedad Medica Del Centro, Materno Infantil General Maximino Avila Camacho 1950;1:57-61.
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CDC 1998 {published data only}
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Cohen 1990 {published data only}
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Darougar 1977 {published data only}
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Dhir 1967 {published data only}
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Drago 1998 {published data only}
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Fok 1995 {published data only}
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Fransen 1984 {published data only}
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Gross 1997 {published data only}
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Hammerschlag 1997 {published data only}
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Hammerschlag 1998 {published data only}
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Heggie 1985 {published data only}
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Horven 1993 {published data only}
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Iroha 1998 {published data only}
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Isenberg 1994 {published data only}
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Jacobson 1988 {published data only}
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Keenan 2010 {published data only}
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Khan 2016 {published data only}
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Klein 1997 {published data only}
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Kramer 1997 {published data only}
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Laga 1986 {published data only}
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Lietman 1998 {published data only}
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Maharajan 1997 {published data only}
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References to studies awaiting assessment

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References to other published versions of this review

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