Every year, about 2.8 million children die in the first month of life, with 98% of these deaths occurring in developing countries. The current WHO recommendation for management of infections in neonates and young infants (0–59 days old) is referral for hospital treatment with a seven to 10 day course of a combination of two injectable antibiotics – penicillin or ampicillin plus gentamicin. However, existing evidence demonstrates that in resource-limited settings many young infants with signs of possible serious bacterial infection (PSBI) do not receive the recommended inpatient treatment because such treatment is not accessible, acceptable or affordable to families. While increasing hospital-based treatment by improving availability and access is imperative, providing effective treatment for young infants with severe infection at first-level health facilities when families do not accept or cannot access referral would increase access to potentially lifesaving care for these infants. Although previously there has been little evidence to evaluate the safety and efficacy of providing care to young infants with PSBI at lower level facilities, a body of research has been conducted over the past decade to inform the creation of evidence-based guidelines. Evaluating data from recently completed studies, it is now possible to develop global clinical and programmatic guidance on management of PSBI where referral for treatment is not feasible.
This guideline, developed by a panel of international experts and informed by a thorough review of existing evidence, provides recommendations on the use of antibiotics for neonates and young infants (0–59 days old) with PSBI in order to reduce young infant mortality rates. This guideline is intended for use in resource-limited settings in situations when families do not accept or cannot access referral. It seeks to provide programmatic guidance on the role of community health workers (CHWs) and home visits in identifying signs of serious infections in neonates and young infants. It also seeks to provide clinical guidance on the simplest antibiotic regimens that are both safe and effective for outpatient treatment of clinical severe infections and fast breathing (pneumonia) in children 0–59 days old.
This guideline will not replace the WHO-recommended inpatient management as the preferred treatment option for young infants who have clinical severe infection or critical illness. Close follow-up is essential for young infants managed on an outpatient basis where referral is not possible.
To develop these recommendations, a WHO Steering Committee and an 18-member Guideline Development Group (GDG) of experts was convened. GDG members each declared their interests, and no conflicts of interest were identified. The group developed a series of priority questions, and WHO commissioned independent institutions to conduct systematic reviews for each question. Based on these reviews, the WHO Steering Committee developed an initial set of draft recommendations. Members of the GDG then reviewed and evaluated the quality of the evidence identified through the systematic reviews using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology (www.gradeworkinggroup.org) and revised and finalized the guideline recommendations. The final recommendations, which were approved by the WHO Guidelines Review Committee, appear in the summary of recommendations below.
The target audience for this guideline includes: 1) national policy-makers in health ministries; 2) programme managers working in child health, essential drugs and health worker training; 3) health care providers and clinicians managing sick children at various levels of health care, including public and private practitioners; and 4) development partners providing financial and/or technical support for child health programmes.
2015 WHO Recommendations on managing possible serious bacterial infection in young infants 0–59 days old when families do not accept or cannot access referral care
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| No. | Recommendation | Strength of recommendation | Quality of evidence |
|---|
| 1 | Community health workers and home visits for postnatal care
At home visits made as part of postnatal care (2), community health workers should counsel families on recognition of danger signs, assess young infants for danger signs of illness and promote appropriate care seeking.a | Strong | Moderate |
| 2 | Infants 0–6 days with fast breathing as the only sign of illness
Young infants 0–6 days old with fast breathing as the only sign of illness should be referred to hospital. If families do not accept or cannot access referral care, these infants should be treated with oral amoxicillin, 50 mg/kg per dose twice daily for seven days, by an appropriately trained health worker. | Strong | Low |
| 3 | Infants 7–59 days with fast breathing as the only sign of illness
Young infants 7–59 days old with fast breathing as the only sign of illness should be treated with oral amoxicillin, 50 mg/kg per dose twice daily for seven days, by an appropriately trained health worker. These infants do not need referral. | Strong | Low |
| 4 | Young infants 0–59 days old with clinical severe infection
Young infants 0–59 days old with clinical severe infection whose families do not accept or cannot access referral care should be managed in outpatient settings by an appropriately trained health worker with one of the following regimens:b | | |
| Option 1: Intramuscular gentamicin 5–7.5 mg/kg (for low-birth-weight infants gentamicin 3–4 mg/kg) once daily for seven days and twice daily oral amoxicillin, 50 mg/kg per dose for seven days. Close follow-up is essential. |
Strong |
Moderate |
| Option 2: Intramuscular gentamicin 5–7.5 mg/kg (for low-birth-weight infants gentamicin 3–4 mg/kg) once daily for two days and twice daily oral amoxicillin, 50 mg/kg per dose for seven days. Close follow-up is essential. A careful assessment on day 4 is mandatory. |
Strong |
Low |
| 5 | Young infants 0–59 days old with critical illness
Young infants 0–59 days old who have any sign of critical illness (at presentation or developed during treatment of clinical severe infection) should be hospitalized after pre-referral treatment (3).c | Strong | Very low |
- a
If birth is in a health facility, mothers and newborns should receive care in the facility for at least 24 hours. If at home, first postnatal contact should be as early as possible within 24 hours. At least three additional postnatal contacts are recommended for all mothers and newborns on day 3 (48–72 hours), between days seven to 14, and six weeks after birth.
- b
Option 1 is the preferred option, but where the health system does not allow this to be implemented, option 2 could be considered. The GDG felt that option 2 likely would be easier to deliver, have more equitable access, have higher adherence, be more affordable and have similar effectiveness. It is expected that individual countries will adapt the recommendations to suit the local social, cultural and economic contexts. Countries are encouraged to hold key stakeholder discussions to inform the decision-making on use and introduction of the recommendations into national programmes.
- c
Give first dose of both ampicillin (50 mg/kg per dose) or benzyl penicillin (50 000 units/kg per dose) and gentamicin (5–7.5 mg/kg per dose) intramuscularly.
