Interventions for preventing ophthalmia neonatorum.

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.

Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: US Preventive Services Task Force Reaffirmation Recommendation Statement.

IMPORTANCE: In the United States, the rate of gonococcal ophthalmia neonatorum was an estimated 0.4 cases per 100 000 live births per year from 2013 to 2017. Gonococcal ophthalmia neonatorum can cause corneal scarring, ocular perforation, and blindness as early as 24 hours after birth. In the absence of ocular prophylaxis, transmission rates of gonococcal infection from mother to newborn are 30% to 50%. OBJECTIVE: To reaffirm the US Preventive Services Task Force (USPSTF) 2011 recommendation on ocular prophylaxis for gonococcal ophthalmia neonatorum. EVIDENCE REVIEW: The USPSTF commissioned a reaffirmation evidence update to identify new and substantial evidence sufficient enough to change its prior recommendation. FINDINGS: Using a reaffirmation process, the USPSTF found no new data that would change its previous conclusion that topical ocular prophylaxis is effective in preventing gonococcal ophthalmia neonatorum and related ocular conditions. The USPSTF found no new data that would change its previous conclusion that there is convincing evidence that topical ocular prophylaxis of all newborns is not associated with serious harms. Therefore, the USPSTF reaffirms its previous conclusion that there is convincing evidence that topical ocular prophylaxis for all newborns provides substantial benefit. CONCLUSIONS AND RECOMMENDATION: The USPSTF recommends prophylactic ocular topical medication for all newborns to prevent gonococcal ophthalmia neonatorum. (A recommendation).

A Survey of Current Prophylactic Treatment for Ophthalmia Neonatorum in Croatia and a Review of International Preventive Practices.

BACKGROUND Ophthalmia neonatorum, or neonatal conjunctivitis, is an acute infection that occurs within the first 28 days of life. This aim of this survey was to evaluate the current methods of preventive treatment for ophthalmia neonatorum in maternity hospitals in Croatia. MATERIAL AND METHODS The annual hospital birth rate in Croatia is approximately 40,000. A clinical survey was undertaken with data collected using questionnaires sent to all 32 maternity hospitals in Croatia. There was a 100% response rate to the questionnaires. RESULTS Preventive treatment for ophthalmia neonatorum was administrated to all newborns in 75% (24/32) of Croatian maternity hospitals. In 45.8% of maternity hospitals, (11/32) these procedures were performed within the first hour after birth. In 54.2% of maternity hospitals (13/32), preventive treatment for ophthalmia neonatorum was administrated to all newborns from one to three hours after birth. The main treatment agent was tobramycin (83.3%). Other topical prophylactic treatments included povidone-iodine (8.3%), erythromycin (4.2%), and silver nitrate (4.2%). In 25% of obstetric units, prophylaxis for ophthalmia neonatorum was not used routinely, but in cases of diagnosed neonatal conjunctivitis, antibiotic treatment with tobramycin was mainly used. CONCLUSIONS A survey of all 32 maternity hospitals in Croatia showed variation in the prevalence of preventive treatment for ophthalmia neonatorum and the methods used. These findings support the need to implement standardized preventive measures that both conform to international clinical guidelines and recognize treatment availability in Croatia, where topical povidone-iodine is currently preferred for the prevention of ophthalmia neonatorum.

Keeping an Eye on Chlamydia and Gonorrhea Conjunctivitis in Infants in the United States, 2010-2015.

Perinatal transmission of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) can result in conjunctivitis in infants. We examined national rates of reported CT/GC conjunctivitis among infants. Surveillance of these infections is heavily affected by the completeness of reported data on specimen source and age. Alternative data sources should be evaluated.

Ophthalmia neonatorum treatment and prophylaxis: IPOSC global study.

INTRODUCTION: Characteristics of ophthalmia neonatorum (ON) amongst paediatric ophthalmologists remain unclear. The purpose of this current study is to examine the incidence, diagnosis, treatment, and prophylaxis of ON cases presenting to members of the American Association of Paediatric Ophthalmology and Strabismus (AAPOS). METHODS: An email containing a web link to a survey was sent to all members of AAPOS. The questionnaire examined the incidence of ON, etiology, diagnostic methods, treatment, and prophylaxis of the disease in different countries around the world. RESULTS: Two hundred and ninety-one ophthalmologists answered the questionnaire. Most were from North America (52.94 %). One hundred and seventy-six (60.69 %) ophthalmologists encountered 0-5 cases of ON per year. The most common pathogens causing ON was Chlamydia trachomatis (35.37 %). Two hundred and forty-two (85.21 %) treat empirically when encountering ON during the first 10 days of life and 205 (75.09 %) after the first 10 days of life. In both cases, erythromycin was the most common first line of treatment. Two hundred and twenty-two (78.72 %) ophthalmologists replied that prophylactic treatment is required in their country. The most common agent for prophylaxis was erythromycin ointment (71.50 %). CONCLUSIONS: We found that the incidence of ON per year per practitioner is 0-5 cases, the most common etiology is C. trachomatis, and most infants receive prophylaxis and treatment.

Erythromycin Prophylaxis for Neonatal Conjunctivitis: Ointment Versus Drops.

BACKGROUND: Due to a shortage of individualized erythromycin ointment (IEO), we switched to shared erythromycin drops (SED). Following this change, nurses claimed observing more cases of eye discharge. OBJECTIVES: To test whether switching from IEO to SED affected the rate of neonatal conjunctivitis (NC). METHODS: The study group included 14,916 neonates > 35 weeks of gestation, further divided into two birth periods of 12 months each: 1 January 2013 to 31 December 2013 (IEO) and 1 February 2014 to 31 January 2015 (SED). We compared the two birth periods with regard to three variables: clinical NC (number of conjunctival swabs/1000 neonates), bacterial NC (number of culture-positive swabs/1000 neonates), and bacterial growth percentage (number of culture-positive swabs/100 samples). RESULTS: Compared to 2012-2013, the period 2014-2015 included fewer cesarean deliveries and shorter length of stay (LOS). Clinical NC, bacterial NC and bacterial-growth percentage were not different between the two periods. Variables that were independently significantly associated with increased clinical NC included male gender (OR 1.48, CI 1.21-1.81) and LOS (OR 1.24, CI 1.18-1.29). LOS was associated with bacterial NC (OR 1.19, CI 1.11-1.28). Coagulase-negative staphylococci, Escherichia coli and Pseudomonas aeruginosa were the prevalent pathogens, though without difference between periods. CONCLUSIONS: Rates of clinical NC, bacterial NC and bacterial-growth percentage were not different between the study periods. Switching from IEO to SED had no effect on the NC rate.

Can we use azithromycin eye drops for gonococcal ophthalmia prophylaxis in the United States?

INTRODUCTION: Neonatal ocular prophylaxis with 0.5% erythromycin ophthalmic ointment is mandated by law in many U.S. states despite its lack of efficacy in preventing chlamydial ophthalmia and the low incidence of gonococcal ophthalmia today. The current shortage of 0.5% erythromycin ophthalmic ointment is bringing into question what alternatives exist for neonatal ocular prophylaxis for the prevention of gonococcal ophthalmia. Providers in states with mandates are concerned with the implications of administering intramuscular ceftriaxone to every newborn. Azithromycin eye drops are being considered as an alternative. AREAS COVERED: This article discusses 1% azithromycin eye drops as an alternative to 0.5% erythromycin ophthalmic ointment. Clinical experience, side effects, resistance, logistics, pharmacokinetics, and pharmacodynamics are considered. EXPERT OPINION: Azithromycin eye drops are not an appropriate alternative to 0.5% erythromycin ophthalmic ointment for ocular prophylaxis. Prenatal screening and treatment of pregnant women is the most effective way to prevent neonatal ophthalmia. Mandates for universal prophylaxis should be withdrawn to avoid unnecessary medication administration, healthcare costs, and potential harm.

Treatment and prevention of ophthalmia neonatorum.

QUESTION: In my office I occasionally see neonates with conjunctivitis. What are the current recommendations for ocular prophylaxis at birth? Do topical antibiotics alone provide adequate treatment of neonatal conjunctivitis? When is systemic therapy indicated? ANSWER: All infants should receive ocular prophylaxis at birth to prevent gonococcal ophthalmia. Neonates presenting with signs of conjunctivitis should have a conjunctival swab sent for Gram stain and culture. If Gram-negative diplococci are present on the Gram stain results, the infants and their parents should be treated immediately for presumed gonorrhea. Infants with chlamydial infection should be treated with oral antibiotics. Most of all other forms of bacterial conjunctivitis can be treated with topical antibiotics, with the exception of Pseudomonas infection. Infants should be followed during their treatment and upon completion of therapy to ensure resolution of symptoms. For cases in which sexually transmitted bacteria are implicated, the mothers and their sexual partners should be treated.

Ophthalmia Neonatorum, Helen Keller, and the Social Dimensions of Eye Disease.

PURPOSE: The aim of this study was to describe how an early 20th-century American celebrity attempted to influence public perception of ophthalmic neonatorum. METHODS: This study reviews the editorial written by Helen Keller in the 1909 Ladies' Home Journal and related historical documents about the prevention of blindness from neonatal conjunctivitis. RESULTS: Although blind, deaf, and nulliparous, Helen Keller at the age of 29 sensed that the newborn children of many American women were being denied preventative treatment for ophthalmia neonatorum. In her editorial in the Ladies' Home Journal discussing the complications of venereal disease she urged women to become proactive in matters of personal and family health care. CONCLUSIONS: Helen Keller viewed blindness from ophthalmia neonatorum as a failure of the American health care system. Her solution was to impart women with enough knowledge to seek care from educated medical professionals. The observation that many women and their children were receiving substandard care reflected a fundamental problem with disparities in the delivery of perinatal health care. Her insights are as relevant today as they were in 1909.

Antibiotic prophylaxis for ophthalmia neonatorum in Italy: results from a national survey and the Italian intersociety new position statements.

BACKGROUND: Ophthalmia neonatorum is an acute conjunctivitis that occurs in newborns within the first month of life. The most serious infections are due to Chlamydia trachomatis and Neisseria gonorrhoeae, that may cause permanent damages. The use of ophthalmic prophylaxis varies widely around the world, according to the different health and socio-economic contexts. To date in Italy there is no a clear legislation regarding ophthalmia neonatorum prophylaxis at birth. METHODS: We invited all birth centers in Italy to carry out a retrospective survey relating the last three years. We collected data regarding demographics of neonates, drugs used for ophthalmic prophylaxis and results of the screening of pregnant women for Chlamydia trachomatis and Neisseria gonorrhoeae vaginal infections. RESULTS: Among 419 birth centers, 302 (72,1%) responded to the survey. Overall 1041384 neonates, 82,3% of those born in the three years considered, received ophthalmic prophylaxis. Only 4,585 (0,4%) of them received one of the drugs recommended by the WHO. The Centers that participated to the survey reported 12 episodes of Chlamydial conjunctivitis and no Gonococcal infection in the three years. Only 38% of the Centers performed vaginal swabs to pregnant women: 2,6% screened only for Neisseria, 9,6% only for Chlamydia and 25,8% for both germs. CONCLUSIONS: The data obtained from the survey showed a low incidence of neonatal conjunctivitis due to either Neisseria gonorrhoeae or Chlamydia trachomatis in Italy. Due to the lack of legislation regulating the prophylaxis of ophthalmia neonatorum in newborns, the Italian Society of Neonatology, the Italian Society of Obstetrics and Gynecology and the Italian Society of Perinatal Medicine have recently issued new recommendations on this topic.

Universal ophthalmia neonatorum prophylaxis in Ontario: a cost-effectiveness analysis.

BACKGROUND: Although prophylaxis for ophthalmia neonatorum at birth is required by law in Ontario, declining prevalence of disease and efficacy of prophylaxis have called this practice into question. The objective of this modelling study was to assess the cost-effectiveness of universal prophylaxis for ophthalmia neonatorum to inform decision-makers on the potential impact of a change in this policy. METHODS: We compared the cost-effectiveness of prophylaxis for ophthalmia neonatorum with no prophylaxis through cost-utility analysis with a lifetime time horizon, considering a provincial government payer, for a hypothetical population of newborns in Ontario. We assessed both the mean incremental costs of prophylaxis and its mean incremental effectiveness using a hybrid (part decision tree, part Markov) model. We used a scenario analysis to evaluate alternative time horizons and discount rates. We conducted a threshold analysis to evaluate the impact of variations in the cost of prophylaxis and in the prevalence of sexually transmitted infections (gonorrhea and chlamydia). RESULTS: In our model, prophylaxis for ophthalmia neonatorum did not meet a willingness-to-pay threshold of Can$50 000 per quality-adjusted life-year (QALY). Although prophylaxis was effective in reducing morbidity associated with ophthalmia neonatorum, the number needed to treat to prevent 1 case of ophthalmia neonatorum blindness was 500 000, with an associated cost of more than Can$4 000 000. When compared with no prophylaxis, prophylaxis had an incremental cost of Can$355 798 per long-term QALY gained (incremental cost-effectiveness ratio). INTERPRETATION: We found that prophylaxis for ophthalmia neonatorum, although individually inexpensive, leads to very high costs on a population level. These findings contribute to the discussion on mandatory prophylaxis currently underway in several jurisdictions.

Efficacy comparison between povidone iodine 2.5% and tetracycline 1% in prevention of ophthalmia neonatorum.

PURPOSE: To evaluate the efficacy of povidone iodine solution 2.5% and tetracycline ointment 1% in prevention of ophthalmia neonatorum (ON). DESIGN: Prospective, randomized, controlled observational study. PARTICIPANTS: Three-hundred ninety-four full-term neonates. METHODS: A randomized comparison between 201 neonates randomly treated with povidone iodine 2.5% solution and 193 treated with tetracycline 1% ointment. MAIN OUTCOMES MEASURES: Incidence of ON. RESULTS: The incidence of ON was significantly higher after povidone iodine than tetracycline prophylaxis (15.4% and 5.2% respectively; P = 0.001). Noninfective ON developed in 10 (5%) of the 201 neonates treated with povidone iodine and in none (0%) of the neonates treated with tetracycline (P = .002). Infective ON was detected in 21 (10.4%) of the neonates treated with povidone iodine and in 10 (5.2%) after treatment with tetracycline (P = .052). Ophthalmia neonatorum appeared more commonly in the first 3 days after treatment with povidone iodine (P = .043). The spectrum of the infective isolates was similar in the 2 groups. CONCLUSIONS: Povidone iodine was associated with noninfective (sterile) conjunctivitis, probably because of its toxicity to the ocular surface in neonates. Tetracycline was marginally more effective against infective ON. For these reasons, tetracycline, rather than povidone iodine, is recommended for prevention of ON.

Prophylaxis for ophthalmia neonatorum in Brazil: A snapshot using a multi-professional national survey.

BACKGROUND: Brazil is a large country with an elevated incidence of Chlamydiatrachomatis (CT) and Neisseriagonorrhoeae (NG) during pregnancy and variable access to health care. The objective of the study was to identify ophthalmia neonatorum prophylaxis practices in the country. METHODS: A prospective multidisciplinary survey was conducted using a closed social media group. Fifteen questions were developed after literature review. Specific content included categorization of respondents and practices such as type of medication, age at administration, occurrence of clinical and/or chemical conjunctivitis and microbiology identification. Questions were multiple choice, but some allowed written response. RESULTS: A total of 1.015 professionals responded, representing 24 states (92%) and 181 cities; mainly neonatologists (64%) and general pediatricians (21%). 96% of respondents reported performing prophylaxis at their institutions, mostly at birth or <1 h of life (99%), and regardless the mode of delivery (73%). Frequently used medications are: 1% silver nitrate (64%), 2.5% povidone iodine (18%) or 10% silver vitelinate (12%), with some regional variations. Occurrence of chemical conjunctivitis was stated by 58% of the respondents and microbiology identification was unusual. CONCLUSIONS: Ophthalmia neonatorum prophylaxis Brazil is almost universal and mainly performed by the use of anti-septic medications, with some regional variability. However, identification and treatment of CT and NG in both parents and newborns is not accomplished.

OPHTHALMIA NEONATORUM in Italy: it is time for change.

Ophthalmia neonatorum (ON) refers to any conjunctivitis occurring in the first 28 days of life. In the past Neisseria gonorrhoeae was the most common cause of ON. It decreased with the introduction of prophylaxis at birth with the instillation of silver nitrate 2% (the Credè's method of prophylaxis). Today, the term ON is used to define any other bacterial infection, in particular due to Chlamydia Trachomatis. Currently, the WHO reccomends topical ocular prophylaxis for prevention of gonococcal and chlamydial conjunctivitis for all neonates. On the contrary, several European countries no longer require universal prophylaxis, opting for screening and treatment of pregnant women at high risk of infection. And what about Italy? Have a look on Italian history of prophylaxis, starting by the first decree issued in 1940, signed by Benito Mussolini. In the following decades the law has undergone many changes. At the moment, legislation is unclear, therefore careful consideration is required in order to draft the correct appoach.

Gonococcal infections in newborns and in adolescents.

Gonococcal infections are now an uncommon problem in newborns in industrialized countries but remain a serious problem in developing countries due to ongoing high infection rates in pregnant women. Prompt diagnosis in the newborn with appropriate treatment can minimize sequelae. The mother and her partner(s) also require investigation and treatment. Adolescents are a core group fuelling the ongoing gonococcal epidemic in industrialized countries. This is unlikely going to change unless sexual behaviour changes substantially. Education is a critical step along with access to more youth friendly STI care. As noted in the 2001 Institute of Medicine Report, learning about sex, sexuality and prevention of STI is a basic human right of adolescents (DiClemente and Crosby 2006).