Simplified Regimens for Management of Neonates and Young Infants With Severe Infection When Hospital Admission Is Not Possible

Tshefu, Antoinette; Lokangaka, Adrien; Engmann, Cyril; Esamai, Fabian; Gisore, Peter; Ayede, Adejumoke Idowu; Falade, Adegoke G; Adejuyigbe, Ebunoluwa A.; Anyabolu, Chineme Henry; Wammanda, Robinson D.; Ogala, WN; Gram, Lu; Bahl, Rajiv; Rollins, Nigel; Yoshida, Sachiyo; Qazi, Shamim

doi:10.1097/inf.0b013e31829ff7d1

Cited by 14 publications

(15 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We used population-based surveillance data from the AFRINEST which was a prospective randomized controlled trial over five sites in three sub-Saharan African countries–Democratic Republic of the Congo (DRC), Kenya, and Nigeria [ 16 , 17 ]. The methodology of the trial has been published [ 27 , 28 ]. Briefly, two trials were conducted—one trial evaluated the simplified antibiotic regimens for management of young infants up to 2 months of age with clinical severe infection when hospital admission was not feasible [ 17 ], and the other compared oral antibiotic and injectable plus oral antibiotic therapies for fast breathing in young infants [ 16 ].…”

Section: Methodsmentioning

confidence: 99%

“…CHWs in DRC and Kenya and Community Health Extension Workers (CHEWs) in Nigeria conducted follow up visits scheduled on days 1, 3, 7, 14, 21, 28, 35, 42, 49, and 59 after birth and assessed young infants for signs of infection ( Panel 1 ). The CHEWs had 2–3 years formal training compared to CHWs who had been trained for a few weeks [ 28 ]. Infants with any sign of infection were referred to a health facility or hospital for further assessment and management.…”

Section: Methodsmentioning

confidence: 99%

“…Study nurses at health facilities examined sick infants identified by CHW/CHEWs to validate signs of infection. Infants with any sign of infection were referred to hospital for treatment and families who refused referral were offered simplified antibiotic regimens on an outpatient basis [ 27 , 28 ]. Quality assurance was ensured by close monitoring and periodic training of all CHWs/CHEWs in WHO/UNICEF caring for newborns in the community training module and the study procedures [ 27 – 29 ].…”

Section: Methodsmentioning

confidence: 99%

“…Several studies, validated the clinical signs used by CHW to identify serious infections in the community from Bangladesh [ 23 – 25 ] and one from Nepal validated signs for umbilical sepsis only at the community level [ 26 ]. None of the studies reported mortality for each sign separately and all reported a much smaller number of newborns followed in the community, compared to AFRIcan NEonatal Sepsis Trial (AFRINEST) [ 27 , 28 ]. Secondly, all studies were conducted in Asia.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Prevalence of clinical signs of possible serious bacterial infection and mortality associated with them from population-based surveillance of young infants from birth to 2 months of age

et al. 2021

View full text Add to dashboard Cite

Background Community-based data on the prevalence of clinical signs of possible serious bacterial infection (PSBI) and the mortality associated with them are scarce. The aim was to examine the prevalence for each sign of infection and mortality associated with infants in the first two months of life, using community surveillance through community health workers (CHW). Methods We used population-based surveillance data of infants up to two months of age from the African Neonatal Sepsis Trial (AFRINEST). In this study, CHWs visited infants up to 10 times during the first two months of life at five sites in three sub-Saharan African countries. CHW assessed the infant for signs of infection (local or systemic) and referred infants who presented with any sign of infection to a health facility. We used a longitudinal analysis to calculate the risk of death associated with the presence of a sign of infection at the time of the visit until the subsequent visit. Results During the first two months of their life, CHWs visited 84,759 live-born infants at least twice. In 11,089 infants (13.1%), one or more signs of infection were identified, of which 237 (2.1%) died. A sign of infection was detected at 2.1% of total visits. In 52% of visits, infants had one or more sign of systemic infection, while 25% had fast breathing in 7–59 days period and 23% had a local infection. All signs of infection, including multiple signs, were more frequently seen in the first week of life. The risk of mortality was very low (0.2%) for local infections and fast breathing in 7–59 days old, it was low for fast breathing 0–6 days old (0.6%), high body temperature (0.7%) and severe chest indrawing (1.0%), moderate for low body temperature (4.9%) and stopped feeding well/not able to feed at all (5.0%) and high for movement only when stimulated or no movement at all (10%) and multiple signs of systemic infection (15.5%). The risk of death associated with most clinical signs was higher (1.5 to 9 times) in the first week of life than at later age, except for low body temperature (4 times lower) as well as high body temperature (2 times lower). Conclusion Signs of infections are common in the first two months of life. The mortality risk differs with clinical signs and can be grouped as very low (local infections, fast breathing 7–59 days), low (fever, severe chest indrawing and fast breathing 0–6 days), moderate (low body temperature and stopped feeding well/not able to feed at all) and high (for movements only on stimulation or no movements at all and multiple signs of infection). New treatment strategies that consider differential mortality risk could be developed and evaluated based on these findings. Clinical trial registration The trial was registered with Australian New Zealand Clinical Trials Registry under ID ACTRN 12610000286044.

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Prevalence of clinical signs of possible serious bacterial infection and mortality associated with them from population-based surveillance of young infants from birth to 2 months of age

et al. 2021

View full text Add to dashboard Cite

show abstract

“…After initial management by nurses, CHEWs continued treatment and followed-up. Detailed methodology of the AFRINEST studies has been published elsewhere [18][19][20][21]. Brief description of the health system and management of patients at study sites is provided in S1 Table. This evidence led to the development of a WHO guideline for managing young infants with PSBI when the referral was not feasible to increase access to treatment [22].…”

Section: Introductionmentioning

confidence: 99%

Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa

et al. 2021

View full text Add to dashboard Cite

Introduction Serious bacterial neonatal infections are a major cause of global neonatal mortality. While hospitalized treatment is recommended, families cannot access inpatient treatment in low resource settings. Two parallel randomized control trials were conducted at five sites in three countries (Democratic Republic of Congo, Kenya, and Nigeria) to compare the effectiveness of treatment with experimental regimens requiring fewer injections with a reference regimen A (injection gentamicin plus injection procaine penicillin both once daily for 7 days) on the outpatient basis provided to young infants (0–59 days) with signs of possible serious bacterial infection (PSBI) when the referral was not feasible. Costs were estimated to quantify the financial implications of scaleup, and cost-effectiveness of these regimens. Methods Direct economic costs (including personnel, drugs and consumable costs) were estimated for identification, prenatal and postnatal visits, assessment, classification, treatment and follow-up. Data on time spent by providers on each activity was collected from 83% of providers. Indirect marginal financial costs were estimated for non-consumables/capital, training, transport, communication, administration and supervision by considering only a share of the total research and health system costs considered important for the program. Total economic costs (direct plus indirect) per young infant treated were estimated based on 39% of young infants enrolled in the trial during 2012 and the number of days each treated during one year. The incremental cost-effectiveness ratio was calculated using treatment failure after one week as the outcome indicator. Experimental regimens were compared to the reference regimen and pairwise comparisons were also made. Results The average costs of treating a young infant with clinical severe infection (a sub-category of PSBI) in 2012 was lowest with regimen D (injection gentamicin once daily for 2 days plus oral amoxicillin twice daily for 7 days) at US$ 20.9 (95% CI US$ 16.4–25.3) or US$ 32.5 (2018 prices). While all experimental regimens B (injection gentamicin once daily plus oral amoxicillin twice daily, both for 7 days), regimen C (once daily of injection gentamicin injection plus injection procaine penicillin for 2 days, thereafter oral amoxicillin twice daily for 5 days) and regimen D were found to be more cost-effective as compared with the reference regimen A; pairwise comparison showed regimen D was more cost-effective than B or C. For fast breathing, the average cost of treatment with regimen E (oral amoxicillin twice daily for 7 days) at US$ 18.3 (95% CI US$ 13.4–23.3) or US$ 29.0 (2018 prices) was more cost-effective than regimen A. Indirect costs were 32% of the total treatment costs. Conclusion Scaling up of outpatient treatment for PSBI when the referral is not feasible with fewer injections and oral antibiotics is cost-effective for young infants and can lead to increased access to treatment resulting in potential reductions in neonatal mortality. Clinical trial registration The trial was registered with Australian New Zealand Clinical Trials Registry under ID ACTRN 12610000286044.

show abstract

Community-based antibiotic delivery for possible serious bacterial infections in neonates in low- and middle-income countries

Duby

Lassi

Bhutta

2019

Cochrane Database of Systematic Reviews

View full text Add to dashboard Cite

show abstract

Simplified Regimens for Management of Neonates and Young Infants With Severe Infection When Hospital Admission Is Not Possible

Cited by 14 publications

References 14 publications

Prevalence of clinical signs of possible serious bacterial infection and mortality associated with them from population-based surveillance of young infants from birth to 2 months of age

Prevalence of clinical signs of possible serious bacterial infection and mortality associated with them from population-based surveillance of young infants from birth to 2 months of age

Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa

Community-based antibiotic delivery for possible serious bacterial infections in neonates in low- and middle-income countries

Contact Info

Product

Resources

About