Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF.

BACKGROUND: Medical devices are critical to providing high-quality, hospital-based newborn care, yet many of these devices are unavailable in low- and middle-income countries (LMIC) and are not designed to be suitable for these settings. Target Product Profiles (TPPs) are often utilised at an early stage in the medical device development process to enable user-defined performance characteristics for a given setting. TPPs can also be applied to assess the profile and match of existing devices for a given context. METHODS: We developed initial TPPs for 15 newborn product categories for LMIC settings. A Delphi-like process was used to develop the TPPs. Respondents completed an online survey where they scored their level of agreement with each of the proposed performance characteristics for each of the 15 devices. Characteristics with < 75% agreement between respondents were discussed and voted on using Mentimeter™ at an in-person consensus meeting. FINDINGS: The TPP online survey was sent to 180 people, of which 103 responded (57%). The majority of respondents were implementers/clinicians (51%, 53/103), with 50% (52/103) from LMIC. Across the 15 TPPs, 403 (60%) of the 668 performance characteristics did not achieve > 75% agreement. Areas of disagreement were voted on by 69 participants at an in-person consensus meeting, with consensus achieved for 648 (97%) performance characteristics. Only 20 (3%) performance characteristics did not achieve consensus, most (15/20) relating to quality management systems. UNICEF published the 15 TPPs in April 2020, accompanied by a report detailing the online survey results and consensus meeting discussion, which has been viewed 7,039 times (as of January 2023). CONCLUSIONS: These 15 TPPs can inform developers and enable implementers to select neonatal care products for LMIC. Over 2,400 medical devices and diagnostics meeting these TPPs have been installed in 65 hospitals in Nigeria, Tanzania, Kenya, and Malawi through the NEST360 Alliance. Twenty-three medical devices identified and qualified by NEST360 meet nearly all performance characteristics across 11 of the 15 TPPs. Eight of the 23 qualified medical devices are available in the UNICEF Supply Catalogue. Some developers have adjusted their technologies to meet these TPPs. There is potential to adapt the TPP process beyond newborn care.

Reducing neonatal infections in south and south central Vietnam: the views of healthcare providers.

BACKGROUND: Infection causes neonatal mortality in both high and low income countries. While simple interventions to prevent neonatal infection are available, they are often poorly understood and implemented by clinicians. A basic understanding of healthcare providers' perceptions of infection control provides a platform for improving current practices. Our aim was to explore the views of healthcare providers in provincial hospitals in south and south central Vietnam to inform the design of programmes to improve neonatal infection prevention and control. METHODS: All fifty-four participants who attended a workshop on infection prevention and control were asked to complete an anonymous, written questionnaire identifying their priorities for improving neonatal infection prevention and control in provincial hospitals in south and south central Vietnam. RESULTS: Hand washing, exclusive breastfeeding and safe disposal of medical waste were nominated by most participants as priorities for preventing neonatal infections. Education through instructional posters and written guidelines, family contact, kangaroo-mother-care, limitation of invasive procedures and screening for maternal GBS infection were advocated by a smaller proportion of participants. CONCLUSIONS: The opinions of neonatal healthcare providers at the workshop accurately reflect some of the current international recommendations for infection prevention. However, other important recommendations were not commonly identified by participants and need to be reinforced. Our results will be used to design interventions to improve infection prevention in Vietnam, and may be relevant to other low-resource countries.

Birthplace is a risk factor for exchange transfusion in outborn infants admitted for jaundice in Myanmar: a case-control study.

Aim: To evaluate the role of pathway to admission for jaundice among the risk factors for exchange transfusion in outborn infants in a low resource setting.Methods: This retrospective case-control study (1:1 ratio) was carried out at the Yankin Children's Hospital in Yangon (Myanmar). All cases were neonates admitted for treatment of jaundice between March 2013 and February 2014 and who required an exchange transfusion. Each control was the next noncase neonate admitted for treatment of jaundice and treated with phototherapy. Infant characteristics, pathways of admission and clinically relevant factors for exchange transfusion were collected.Results: One hundred thirty-four cases and 134 controls were included in the study. Among cases, home was the most common place of birth while public hospital was the most frequent source of referral. Among controls, private/public hospitals were the commonest places of birth and referral. At multivariable analysis, homebirth was associated with increased likelihood of receiving exchange transfusion at admission (OR 3.30, 95% C.I. 1.31-8.56).Conclusion: Homebirth was an independent risk factor for exchange transfusion at admission for jaundice in a low-resource setting. Appropriate health education of pregnant women and traditional/home birth attendants may contribute to reduce the need for exchange transfusion in low-resource settings.