Can a Baby with a Possible Serious Infection Be Treated Safely at Home?

A large study in Africa and south Asia comparing home and hospital antibiotic treatment, and a review of how many sick babies actually get the care they need

In poorer countries, babies under two months old with signs of a possible serious infection have long been sent to hospital for a week of injections. A study of 7001 babies in Africa and south Asia found that babies with just one milder warning sign did as well with two days of injections plus antibiotic medicine by mouth at home. A second study shows that many sick babies still miss out on complete treatment.

Few things worry new parents more than a sick young baby. Very young babies cannot fight infections as well as older children, and a serious infection can become dangerous quickly. Doctors in places without quick laboratory tests have to decide what to do based on what they can see and measure: a high temperature, unusually fast breathing, or the lower chest sucking in hard with each breath. This article explains two recent studies that help answer a practical question for families and health workers: where is the best place to treat these babies, and how many of them actually get treated [1][2]?

Why this question has mattered for so long

Infections are one of the biggest causes of death in newborn babies around the world. In a large study that followed families in communities across south Asia and sub-Saharan Africa, severe infections caused about 35 to 37 out of every 100 newborn deaths [3]. Doctors use the term "possible serious bacterial infection", often shortened to PSBI, for a baby who shows warning signs of a serious infection caused by bacteria (germs that antibiotics can kill). It is called "possible" because, without laboratory tests, nobody can be sure an infection is there. Researchers estimated that 6.9 million newborns in Africa, south Asia and Latin America needed treatment for PSBI in a single year, 2012 [4].

For many years, the World Health Organization (WHO), the United Nations agency for health, advised that every baby with any of these signs should go to hospital for at least seven days of antibiotic injections [1]. But for many families that was simply not possible. Hospitals can be far away, transport and the stay cost money, and parents may have other children to care for. In one rural area of Bangladesh, more than 8 out of 10 families with such a baby could not take the baby to hospital [5]. Earlier research groups therefore tested simpler treatments for babies whose families could not go to hospital. A study called the African Neonatal Sepsis Trial (AFRINEST), carried out in the Democratic Republic of the Congo, Kenya and Nigeria, found that two days of injections plus seven days of antibiotic medicine by mouth worked as well as a full week of injections [6], and a similar study in Bangladesh agreed [7]. In 2015, WHO accepted home treatment, but only as a back-up plan for families who could not reach hospital [8]. A study in Pakistan, published the following year, reached the same conclusion [9]. Then a closer look at the AFRINEST babies suggested something surprising: babies with milder warning signs who were treated at home seemed to die less often than those treated in hospital [10]. Because the families had chosen where to be treated, though, that comparison could not prove anything. A fair test was needed.

How the new study was done

The new study was organised by a team called the Possible Serious Bacterial Infection (PSBI) Study Group, coordinated by WHO [1]. It took place in hospitals at seven sites in six countries: Bangladesh, Ethiopia, India (two sites), Nigeria, Pakistan and Tanzania, between 2021 and 2024. It included 7001 babies under two months old who had only one of three warning signs that earlier research had linked to a lower risk of death: a temperature of 38°C or higher, a strong pull-in of the lower chest, or very fast breathing (60 or more breaths a minute) in the first week of life. Babies who were very small, had other worrying signs, or (from late 2023) had low oxygen levels were not included.

The babies were placed into one of two groups by chance, like the toss of a coin, which makes the comparison fair. About half (3501 babies) were treated as outpatients, meaning they went home: they had an antibiotic injection on the first day and came back for a second on day 2, and their parents gave them an antibiotic called amoxicillin by mouth, twice a day for seven days. The other half (3500 babies) stayed in hospital for at least a week of antibiotic injections. Separate staff, who had not been involved in treating the babies, checked on every baby on days 2, 4, 8 and 15 to see who had become sicker, still had their warning sign, or had died.

What the study found

Home treatment worked as well as hospital treatment. A "poor outcome", meaning a baby who became more seriously ill, developed new warning signs, still had the original sign on day 8, or died, happened to about 8 out of every 100 babies in both groups: 269 babies at home and 272 in hospital [1]. That is why the researchers concluded home treatment was "no worse" than hospital care.

Deaths were rare in both groups, but fewer babies died in the home group: 9 out of 3501, compared with 23 out of 3500 in hospital. The researchers think one reason may be that babies treated at home avoid infections picked up on hospital wards [1], which are common in hospitals in poorer countries [11]. This idea was not tested in the study, and because the numbers of deaths were small, it should be seen as encouraging rather than final. There was also a small finding pointing the other way: the original warning sign was still present on day 8 in slightly more babies treated at home (109) than in hospital (81). This is a reminder that the follow-up check-ups are an important part of home treatment.

Families also found home treatment easier to stick with. About 9 out of 10 babies in both groups received every dose of their treatment, and far fewer families left the study in the home group (26) than in the hospital group (69), many of whom did not want their baby to stay in hospital. Serious side effects were very rare, and none was judged to be caused by the medicines.

The second study: how many babies actually get treated?

A treatment only helps the babies who receive it. The second paper, by Mekonnen and colleagues, brought together 16 earlier projects, mostly in Africa and south Asia, that offered simpler antibiotic treatment close to home when hospital was not an option [2]. The researchers counted how many sick babies were lost at each step of care, an approach recommended by international health experts for measuring whether health services truly help people [12]. Out of every 100 babies expected to need treatment, on average about 71 were brought to a health worker, 67 started antibiotics, and 56 were both treated and recovered. The results varied enormously from place to place: a project in one rural district of India reached about half of the babies expected to need care [13], while one in two districts of northern Ethiopia reached close to 9 out of 10 [14].

The two papers fit together like two halves of a story. The trial shows that home treatment works when it is delivered well. The review shows that, in everyday programmes, many babies still slip through the gaps. The review's search for studies ended before the trial's results came out, so it could not include them. In[Neo]Sight's own reading of the review (not something its authors state) suggests that some projects may have been counted twice, so its averages are best seen as rough guides.

What this means for families

If you live in a place where these guidelines are used, and your baby has only one of these warning signs and is otherwise well enough, health workers may soon offer treatment at home rather than a hospital stay. The study authors have asked WHO to review its advice so that home treatment becomes the first choice for these babies [1]. Home treatment does not mean less care. It depends on parents giving every dose of medicine, bringing the baby back for the second injection, going to every check-up, and returning straight away if the baby stops feeding well, has a fit (convulsion), moves less than usual or seems to be getting worse. Babies with more serious signs still need hospital care.

What researchers are working on next

The same research group has also carried out a related study to find out whether babies with somewhat more serious signs can go home after two days in hospital [15]; when the main trial was published, its results were still to come. Scientists are also working on quick bedside tests that can tell whether an infection is caused by bacteria or by a virus, which antibiotics cannot treat [1][16]. A large study in south Asia found a clear cause in only 28 out of every 100 such illnesses [17], so better tests could spare many babies unnecessary antibiotics. Readers interested in how doctors decide how long antibiotics are needed can see our article on shorter antibiotic courses for newborn infections.

The bottom line

For young babies with just one milder warning sign of a possible serious infection, careful treatment at home, with two injections, antibiotic medicine by mouth and regular check-ups, worked as well as a week in hospital, and fewer babies died. The next task is making sure every sick baby is found, treated and followed up until they are well.

References

  1. PSBI Study Group. Inpatient versus outpatient management of young infants with a single low-mortality-risk sign of possible serious bacterial infection in sub-Saharan Africa and south Asia: an open-label, multicentre, two-arm, randomised controlled trial. Lancet Glob Health. 2025;13(11):e1892-e1902. doi:10.1016/S2214-109X(25)00243-800243-8) ↩
  2. Mekonnen WN, Tiruneh GT, Berhane A, Mekonnen W. Effective treatment coverage for sick young infants with possible serious bacterial infection when referral not feasible in low-and middle-income countries: systematic review and meta-analysis. BMC Public Health. 2025;26(1):404. doi:10.1186/s12889-025-25934-9 ↩
  3. Alliance for Maternal and Newborn Health Improvement (AMANHI) mortality study group. Population-based rates, timing, and causes of maternal deaths, stillbirths, and neonatal deaths in south Asia and sub-Saharan Africa: a multi-country prospective cohort study. Lancet Glob Health. 2018;6(12):e1297-e1308. doi:10.1016/S2214-109X(18)30385-130385-1) ↩
  4. Seale AC, Blencowe H, Manu AA, et al. Estimates of possible severe bacterial infection in neonates in sub-Saharan Africa, south Asia, and Latin America for 2012: a systematic review and meta-analysis. Lancet Infect Dis. 2014;14(8):731-741. doi:10.1016/S1473-3099(14)70804-770804-7) ↩
  5. Applegate JA, Ahmed S, Harrison M, et al. Caregiver acceptability of the guidelines for managing young infants with possible serious bacterial infections (PSBI) in primary care facilities in rural Bangladesh. PLoS One. 2020;15(4):e0231490. doi:10.1371/journal.pone.0231490 ↩
  6. Tshefu A, Lokangaka A, Ngaima S, et al. Simplified antibiotic regimens compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with clinical signs of possible serious bacterial infection when referral is not possible: a randomised, open-label, equivalence trial. Lancet. 2015;385(9979):1767-1776. doi:10.1016/S0140-6736(14)62284-462284-4) ↩
  7. Baqui AH, Saha SK, Ahmed AS, et al. Safety and efficacy of alternative antibiotic regimens compared with 7 day injectable procaine benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible: a randomised, open-label, equivalence trial. Lancet Glob Health. 2015;3(5):e279-287. doi:10.1016/S2214-109X(14)70347-X70347-X) ↩
  8. World Health Organization. Guideline: managing possible serious bacterial infection in young infants when referral is not feasible. Geneva: World Health Organization; 2015. ISBN 9789241509268. https://www.who.int/publications/i/item/9789241509268 ↩
  9. Mir F, Nisar I, Tikmani SS, et al. Simplified antibiotic regimens for treatment of clinical severe infection in the outpatient setting when referral is not possible for young infants in Pakistan (Simplified Antibiotic Therapy Trial [SATT]): a randomised, open-label, equivalence trial. Lancet Glob Health. 2017;5(2):e177-e185. doi:10.1016/S2214-109X(16)30335-730335-7) ↩
  10. Nisar YB, Tshefu A, Longombe AL, et al. Clinical signs of possible serious infection and associated mortality among young infants presenting at first-level health facilities. PLoS One. 2021;16(6):e0253110. doi:10.1371/journal.pone.0253110 ↩
  11. Allegranzi B, Bagheri Nejad S, Combescure C, et al. Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis. Lancet. 2011;377(9761):228-241. doi:10.1016/S0140-6736(10)61458-461458-4) ↩
  12. Marsh AD, Muzigaba M, Diaz T, et al. Effective coverage measurement in maternal, newborn, child, and adolescent health and nutrition: progress, future prospects, and implications for quality health systems. Lancet Glob Health. 2020;8(5):e730-e736. doi:10.1016/S2214-109X(20)30104-230104-2) ↩
  13. Awasthi S, Kesarwani N, Verma RK, et al. Identification and management of young infants with possible serious bacterial infection where referral was not feasible in rural Lucknow district of Uttar Pradesh, India: An implementation research. PLoS One. 2020;15(6):e0234212. doi:10.1371/journal.pone.0234212 ↩
  14. Leul A, Hailu T, Abraham L, et al. Innovative approach for potential scale-up to jump-start simplified management of sick young infants with possible serious bacterial infection when a referral is not feasible: Findings from implementation research. PLoS One. 2021;16(2):e0244192. doi:10.1371/journal.pone.0244192 ↩
  15. PSBI Study Group. How long should young infants less than two months of age with moderate-mortality-risk signs of possible serious bacterial infection be hospitalised for? Study protocol for a randomised controlled trial from low- and middle-income countries. J Glob Health. 2023;13:04056. doi:10.7189/jogh.13.04056 ↩
  16. Gleeson B, Ferreyra C, Palamountain K, et al. A call to bridge the diagnostic gap: diagnostic solutions for neonatal sepsis in low- and middle-income countries. BMJ Glob Health. 2024;9(9):e015862. doi:10.1136/bmjgh-2024-015862 ↩
  17. Saha SK, Schrag SJ, El Arifeen S, et al. Causes and incidence of community-acquired serious infections among young children in south Asia (ANISA): an observational cohort study. Lancet. 2018;392(10142):145-159. doi:10.1016/S0140-6736(18)31127-931127-9) ↩