RESUMO
Children hospitalised for severe acute malnutrition (SAM) have a high risk of mortality, relapse and rehospitalisation following hospital discharge. Current approaches fail to promote convalescence, or to address the underlying social determinants of SAM, meaning that restoration of long-term health, growth and neurodevelopment is not achieved. Although guidelines recommend play and stimulation to promote recovery, most caregivers are not supported to do this at home. We set out to evaluate the feasibility and acceptability of a codesigned intervention package aimed at providing child stimulation through play, and strengthening caregiver capabilities through problem-solving skills, peer support and income-generating activities. We evaluated the intervention in two phases, enroling 30 caregiver-child pairs from paediatric wards in Harare, Zimbabwe, once children who had been hospitalised with SAM were ready for discharge. Children were median 17.8 months old, and 28.6% had human immunodeficiency virus. Trained intervention facilitators (IFs)-lay workers whose own children had previously had SAM-delivered the intervention over 12 weeks with nurse supervision. Qualitative interviews with caregivers and IFs showed that the intervention was feasible and acceptable. Participants reported benefiting from the psychosocial support and counselling, and several started income-generating projects. Caregivers appreciated the concept of play and caregiver-child interaction, and all reported practising what they had learned. By Week 12, caregiver mental health and caregiver-child interaction improved significantly. Overall, the intervention was feasible, acceptable and showed promise in modifying caregiver knowledge, attitudes and practice. An efficacy trial is now needed to evaluate whether the intervention can improve child convalescence following complicated SAM.
RESUMO
Malnutrition underlies almost half of all child deaths globally. Severe Acute Malnutrition (SAM) carries unacceptable mortality, particularly if accompanied by infection or medical complications, including enteropathy. We evaluated four interventions for malnutrition enteropathy in a multi-centre phase II multi-arm trial in Zambia and Zimbabwe and completed in 2021. The purpose of this trial was to identify therapies which could be taken forward into phase III trials. Children of either sex were eligible for inclusion if aged 6-59 months and hospitalised with SAM (using WHO definitions: WLZ <-3, and/or MUAC <11.5 cm, and/or bilateral pedal oedema), with written, informed consent from the primary caregiver. We randomised 125 children hospitalised with complicated SAM to 14 days treatment with (i) bovine colostrum (n = 25), (ii) N-acetyl glucosamine (n = 24), (iii) subcutaneous teduglutide (n = 26), (iv) budesonide (n = 25) or (v) standard care only (n = 25). The primary endpoint was a composite of faecal biomarkers (myeloperoxidase, neopterin, α1-antitrypsin). Laboratory assessments, but not treatments, were blinded. Per-protocol analysis used ANCOVA, adjusted for baseline biomarker value, sex, oedema, HIV status, diarrhoea, weight-for-length Z-score, and study site, with pre-specified significance of P < 0.10. Of 143 children screened, 125 were randomised. Teduglutide reduced the primary endpoint of biomarkers of mucosal damage (effect size -0.89 (90% CI: -1.69,-0.10) P = 0.07), while colostrum (-0.58 (-1.4, 0.23) P = 0.24), N-acetyl glucosamine (-0.20 (-1.01, 0.60) P = 0.67), and budesonide (-0.50 (-1.33, 0.33) P = 0.32) had no significant effect. All interventions proved safe. This work suggests that treatment of enteropathy may be beneficial in children with complicated malnutrition. The trial was registered at ClinicalTrials.gov with the identifier NCT03716115.