Chlorhexidine for facility-based umbilical cord care: EN-BIRTH multi-country validation study.

BACKGROUND: Umbilical cord hygiene prevents sepsis, a leading cause of neonatal mortality. The World Health Organization recommends 7.1% chlorhexidine digluconate (CHX) application to the umbilicus after home birth in high mortality contexts. In Bangladesh and Nepal, national policies recommend CHX use for all facility births. Population-based household surveys include optional questions on CHX use, but indicator validation studies are lacking. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) was an observational study assessing measurement validity for maternal and newborn indicators. This paper reports results regarding CHX. METHODS: The EN-BIRTH study (July 2017-July 2018) included three public hospitals in Bangladesh and Nepal where CHX cord application is routine. Clinical-observers collected tablet-based, time-stamped data regarding cord care during admission to labour and delivery wards as the gold standard to assess accuracy of women's report at exit survey, and of routine-register data. We calculated validity ratios and individual-level validation metrics; analysed coverage, quality and measurement gaps. We conducted qualitative interviews to assess barriers and enablers to routine register-recording. RESULTS: Umbilical cord care was observed for 12,379 live births. Observer-assessed CHX coverage was very high at 89.3-99.4% in all 3 hospitals, although slightly lower after caesarean births in Azimpur (86.8%), Bangladesh. Exit survey-reported coverage (0.4-45.9%) underestimated the observed coverage with substantial "don't know" responses (55.5-79.4%). Survey-reported validity ratios were all poor (0.01 to 0.38). Register-recorded coverage in the specific column in Bangladesh was underestimated by 0.2% in Kushtia but overestimated by 9.0% in Azimpur. Register-recorded validity ratios were good (0.9 to 1.1) in Bangladesh, and poor (0.8) in Nepal. The non-specific register column in Pokhara, Nepal substantially underestimated coverage (20.7%). CONCLUSIONS: Exit survey-report highly underestimated observed CHX coverage in all three hospitals. Routine register-recorded coverage was closer to observer-assessed coverage than survey reports in all hospitals, including for caesarean births, and was more accurately captured in hospitals with a specific register column. Inclusion of CHX cord care into registers, and tallied into health management information system platforms, is justified in countries with national policies for facility-based use, but requires implementation research to assess register design and data flow within health information systems.

Functional performance study of an adapted design of the woman's condom: a crossover, noninferiority, randomized clinical trial.

Objectives: We aimed to assess the functional performance and safety of a modified Woman's Condom (WC2) against the existing FC2 female condom. Study design: This randomized clinical trial enrolled 287 women in one South African site. The primary outcome of the study was the rate of female condom failure. Participants were asked to use five of each female condom type and to collect information on use in a condom log at home and were interviewed after use of each FC type. Results: Noninferiority was demonstrated for the WC2 with respect to the reference condom FC2 for all condom functions. The WC2 was found to be superior to the FC2 reference condom for clinical failure (p = .000), total female condom failure (p = .001), misdirection (p = .000) and slippage (p = .004). Conclusion: The WC2 female condom performs as well as the FC2 female condom and offers good stability during use. Implications: Results from this study will inform further refinement of this female condom design, resulting in a new and potentially less expensive Woman's Condom.

A Randomized Crossover Study Evaluating the Use and Acceptability of the SILCS Diaphragm Compared to Vaginal Applicators for Vaginal Gel Delivery.

INTRODUCTION: This study aimed to assess acceptability and preferences for the SILCS diaphragm for vaginal gel delivery compared to a prefilled applicator. METHODS: A randomized crossover study among 115 women in South Africa, using both methods during five sex acts. RESULTS: We found no significant differences in acceptability between the two products. Experience of gel leakage after sex was greater when inserted via applicator. More women were interested in SILCS/gel for multipurpose protection (68%) than in either SILCS alone (17%) or microbicide gel alone (14%). CONCLUSIONS: A SILCS gel delivery system for multipurpose prevention seems feasible and acceptable.

Umbilical cord-care practices in low- and middle-income countries: a systematic review.

BACKGROUND: Neonatal sepsis is the third leading cause of deaths for infants in their first month of life. The newly cut umbilical cord can be a pathway for bacteria that can cause newborn sepsis and death. Optimal umbilical cord care practices for newborns and during the first week of life, especially in settings with poor hygiene, has the potential to avoid these preventable neonatal deaths. The purpose of this review of cord care practices is to assist in the development of behavior-change strategies to support introduction of novel cord-care regimens, particularly 7.1% chlorhexidine digluconate for umbilical cord care. METHODS: We searched domestic and international databases for articles that were published in English between January 1, 2000, and August 24, 2016. We found 321 articles and reviewed 65 full-text articles using standardized inclusion criteria. The primary criteria for inclusion was a description of substances applied to the umbilical cord stump in the days following birth. RESULTS: We included 46 articles in this review of umbilical cord-care practices. Articles included data from 15 low- and middle-income countries in sub-Saharan Africa (8 countries), Asia (5 countries), North Africa (1 country), and Latin America and the Caribbean (1 country). Findings from this review suggest that documentation of cord-care practices is not consistent throughout low- and middle-income countries, yet existing literature depicts a firm tradition of umbilical cord care in every culture. Cord-care practices vary by country and by regions or cultural groups within a country and employ a wide range of substances. The desire to promote healing and hasten cord separation are the underlying beliefs related to application of substances to the umbilical cord. The frequency of application of the substance (either the number of days or the number of times per day the substance was applied), and source and cost of products used is not well-characterized. CONCLUSIONS: This desire to actively care for the umbilical cord of a newborn-as noted in the variety of cord care practices and beliefs identified in this review-points toward the need to contextualize any behavior change approach to align with the local culture.

Transformative Innovations in Reproductive, Maternal, Newborn, and Child Health over the Next 20 Years.

As part of the "Grand Convergence: Aligning Technologies and Realities in Global Health" Collection, Cyril Engmann and colleagues discuss promising innovations that have the potential to move the RMNCH agenda forward.

Count every newborn; a measurement improvement roadmap for coverage data.

BACKGROUND: The Every Newborn Action Plan (ENAP), launched in 2014, aims to end preventable newborn deaths and stillbirths, with national targets of ≤12 neonatal deaths per 1000 live births and ≤12 stillbirths per 1000 total births by 2030. This requires ambitious improvement of the data on care at birth and of small and sick newborns, particularly to track coverage, quality and equity. METHODS: In a multistage process, a matrix of 70 indicators were assessed by the Every Newborn steering group. Indicators were graded based on their availability and importance to ENAP, resulting in 10 core and 10 additional indicators. A consultation process was undertaken to assess the status of each ENAP core indicator definition, data availability and measurement feasibility. Coverage indicators for the specific ENAP treatment interventions were assigned task teams and given priority as they were identified as requiring the most technical work. Consultations were held throughout. RESULTS: ENAP published 10 core indicators plus 10 additional indicators. Three core impact indicators (neonatal mortality rate, maternal mortality ratio, stillbirth rate) are well defined, with future efforts needed to focus on improving data quantity and quality. Three core indicators on coverage of care for all mothers and newborns (intrapartum/skilled birth attendance, early postnatal care, essential newborn care) have defined contact points, but gaps exist in measuring content and quality of the interventions. Four core (antenatal corticosteroids, neonatal resuscitation, treatment of serious neonatal infections, kangaroo mother care) and one additional coverage indicator for newborns at risk or with complications (chlorhexidine cord cleansing) lack indicator definitions or data, especially for denominators (population in need). To address these gaps, feasible coverage indicator definitions are presented for validity testing. Measurable process indicators to help monitor health service readiness are also presented. A major measurement gap exists to monitor care of small and sick babies, yet signal functions could be tracked similarly to emergency obstetric care. CONCLUSIONS: The ENAP Measurement Improvement Roadmap (2015-2020) outlines tools to be developed (e.g., improved birth and death registration, audit, and minimum perinatal dataset) and actions to test, validate and institutionalise proposed coverage indicators. The roadmap presents a unique opportunity to strengthen routine health information systems, crosslinking these data with civil registration and vital statistics and population-based surveys. Real measurement change requires intentional transfer of leadership to countries with the greatest disease burden and will be achieved by working with centres of excellence and existing networks.

Prioritizing investments in innovations to protect women from the leading causes of maternal death.

PATH, an international nonprofit organization, assessed nearly 40 technologies for their potential to reduce maternal mortality from postpartum hemorrhage and preeclampsia and eclampsia in low-resource settings. The evaluation used a new Excel-based prioritization tool covering 22 criteria developed by PATH, the Maternal and Neonatal Directed Assessment of Technology (MANDATE) model, and consultations with experts. It identified five innovations with especially high potential: technologies to improve use of oxytocin, a uterine balloon tamponade, simplified dosing of magnesium sulfate, an improved proteinuria test, and better blood pressure measurement devices. Investments are needed to realize the potential of these technologies to reduce mortality.

Potential for revitalisation of the diaphragm for family planning in Uganda: a rapid assessment of the feasibility of introducing the SILCS Diaphragm.

This health systems assessment evaluated the feasibility of introducing a new contraceptive device, the SILCS single-size diaphragm, into the existing family planning method mix in Uganda. A total of 26 focus group discussions with 201 female and 77 male potential users and 98 key informant interviews with policymakers and providers were conducted between June and August 2010. Potential users, providers, and policymakers recognised that the SILCS Diaphragm could fill a gap in the method mix and expressed eagerness to make the SILCS Diaphragm available, particularly because it is nonhormonal and woman initiated. The diaphragm was viewed by all stakeholders as a method that would increase choice and could improve women's reproductive health in Uganda. Like many countries, Uganda's family planning programme is financially stretched, and clear support for the SILCS Diaphragm by end-users will need to be demonstrated before the product will be considered for public-sector introduction.

Perceived progress toward scale of 14 maternal, newborn, child health, and nutrition (MNCHN) assets at subnational level in Burkina Faso, Ethiopia, India, Kenya, and Nigeria.

Inequitable coverage of evidence-based MNCHN interventions is particularly pronounced in low and middle income countries where access and delivery of these interventions can vary dramatically at the subnational level. We conducted health system assessments in nine subnational geographies in five countries (Burkina Faso, Ethiopia, India, Kenya and Nigeria) to explore progress toward scale of 14 evidence-based MNCHN interventions (iron-folic acid, oxytocin, magnesium sulfate, misoprostol; 7.1% chlorhexidine for umbilical cord care, neonatal resuscitation, kangaroo mother care, community regimen for the treatment of possible severe bacterial infection; amoxicillin dispersible tablets, multiple micronutrient supplements, balanced energy protein supplementation, early and exclusive breastfeeding, feeding of small and sick newborns, and management of severe and moderate acute malnutrition in children less than five years old). Between March and October 2021, we conducted key informant interviews with a purposive sample of 275 healthcare providers and 94 district health management (DHMT) staff to better understand bottlenecks, facilitators and uptake of the interventions across varied subnational settings. Across all interventions and geographies, providers and DHMT staff perceived lack of robust HMIS data as the most significant barrier to scale followed by weak facility infrastructure. DHMT staff viewed limited budget allocation and training as a much larger barrier than healthcare providers, most likely given their purview as subnational managers. Healthcare providers were focused on supply chain and staffing, which affect workflows and service provision. Understanding provider and health facility management views of why interventions do or do not advance towards effective coverage can assist in creating enabling environments for the scale of best practices. These types of data are most helpful when collected at the subnational level, which allows for comparisons both within and between countries to show health disparities. Importantly, this strategic data collection can provide a starting point for improvement efforts to address existing health system gaps.

Willingness to pay for a 4% chlorhexidine (7.1% chlorhexidine digluconate) product for umbilical cord care in rural Bangladesh: a contingency valuation study.

BACKGROUND: Recent trials in Bangladesh, Nepal, and Pakistan have shown that chlorhexidine is an effective antiseptic for umbilical cord care compared to existing community-based cord care practices. Because of the aggregate reduction in neonatal mortality in these trials, interest is high in introducing a 7.1% chlorhexidine digluconate liquid or gel that delivers 4% chlorhexidine for umbilical cord care in Bangladesh and elsewhere. METHODS: In 2010, we conducted a household survey applying a contingent valuation method with 1717 eligible couples (pregnant women or women with a first child younger than 6 months old, and their husbands) in the rural subdistricts of Abhoynagar and Mirsarai in Bangladesh to assess their willingness to pay for three types of umbilical cord care products at different price points. Each respondent was asked about willingness to pay prefixed prices for any one of three 7.1% chlorhexidine digluconate products: 1) a single-dose liquid, 2) a multi-dose liquid, or 3) a gel formulation. Each also reported the maximum price they were independently willing to pay for their selected product. We compared participant willingness-to-pay responses to the prefixed prices with their independently reported maximum prices for each type of the product separately. The comparison identified to what extent the respondents' positive responses to the prefixed prices matched their independently reported maximum prices. RESULTS: This cross matching revealed that willingness to pay the prefixed prices was 41% for the single-dose liquid, 33% for the multi-dose liquid, and 31% for the gel formulation. Although the majority of the respondents were unwilling to pay the prefixed prices, all were willing to pay some amount and reported they could borrow money if necessary. Subsequent analysis of responses to the multi-dose liquid showed borrowing money would not be required if the unit price was Bangladeshi taka 15-25. CONCLUSIONS: A unit price of Bangladeshi taka 15-25 (US$0.21-0.35) for multi-dose 7.1% chlorhexidine digluconate liquid would be affordable to the primary target population in Bangladesh. Although a large market demand could be generated if the product were available at this price point, subsidization may be required to achieve optimal coverage, especially among poorer families.

Microarray patch for HIV prevention and as a multipurpose prevention technology to prevent HIV and unplanned pregnancy: an assessment of potential acceptability, usability, and programmatic fit in Kenya.

Background: Microarray patches (MAPs), a novel drug delivery system, are being developed for HIV pre-exposure prophylaxis (PrEP) delivery and as a multipurpose prevention technology (MPT) to protect from both HIV and unintended pregnancy. Prevention technologies must meet the needs of target audiences, be acceptable, easy to use, and fit health system requirements. Methodology: We explored perceptions about MAP technology and assessed usability, hypothetical acceptability, and potential programmatic fit of MAP prototypes using focus group discussions (FGD), usability exercises, and key informant interviews (KII) among key populations in Kiambu County, Kenya. Adolescent girls and young women (AGYW), female sex workers (FSW), and men who have sex with men (MSM) assessed the usability and acceptability of a MAP prototype. Male partners of AGYW/FSW assessed MAP acceptability as partners of likely users. We analyzed data using NVivo, applying an inductive approach. Health service providers and policymakers assessed programmatic fit. Usability exercise participants applied a no-drug, no-microneedle MAP prototype and assessed MAP features. Results: We implemented 10 FGD (4 AGYW; 2 FSW; 2 MSM; 2 male partners); 47 mock use exercises (19 AGYW; 9 FSW; 8 MSM; 11 HSP); and 6 policymaker KII. Participants reported high interest in MAPs due to discreet and easy use, long-term protection, and potential for self-administration. MAP size and duration of protection were key characteristics influencing acceptability. Most AGYW preferred the MPT MAP over an HIV PrEP-only MAP. FSW saw value in both MAP indications and voiced need for MPTs that protect from other infections. Preferred duration of protection was 1-3 months. Some participants would accept a larger MAP if it provided longer protection. Participants suggested revisions to the feedback indicator to improve confidence. Policymakers described the MPT MAP as "killing two birds with one stone," in addressing AGYW needs for both HIV protection and contraception. An MPT MAP is aligned with Kenya's policy of integrating health care programs. Conclusions: MAPs for HIV PrEP and as an MPT both were acceptable across participant groups. Some groups valued an MPT MAP over an HIV PrEP MAP. Prototype refinements will improve usability and confidence.

The Journey Toward Establishing Inpatient Care for Small and Sick Newborns in Ethiopia, India, Malawi, and Rwanda.

BACKGROUND: Limited information is available about the approaches used and lessons learned from low- and middle-income countries that have implemented inpatient services for small and sick newborns. We developed descriptive case studies to compare the journeys to establish inpatient newborn care across Ethiopia, India, Malawi, and Rwanda. METHODS: A total of 57 interviews with stakeholders in Ethiopia (n=12), India (n=12), Malawi (n=16), and Rwanda (n=17) informed the case studies. Our heuristic data analysis followed a deductive organizing framework approach. We informed our data analysis via targeted literature searches to uncover details related to key events. We used the NEST360 Theory of Change for facility-based care, which reflects the World Health Organization (WHO) Health Systems Framework as a starting point and added, as necessary, in an edit processing format until data saturation was achieved. FINDINGS: Results highlight the strategies and innovation used to establish small and sick newborn care by health system building block and by country. We conducted a gap analysis of implementation of WHO Standards for Improving Facility-Based Care. The journeys to establish inpatient newborn care across the 4 countries are similar in terms of trajectory yet unique in their implementation. Unifying themes include leadership and governance at national level to consolidate and coordinate action to improve newborn quality of care, investment to build staff skills on data collection and use, and institutionalization of regular neonatal data reviews to identify gaps and propose relevant strategies. CONCLUSION: Efforts to establish and scale inpatient care for small and sick newborns in Ethiopia, India, Malawi, and Rwanda over the last decade have led to remarkable success. These country examples can inspire more nascent initiatives that other low- and middle-income countries may undertake. Documentation should give voice to lived country experience, not all of which is fully captured in existing, peer-reviewed published literature.

Feasibility and usability of a very low-cost bubble continuous positive airway pressure device including oxygen blenders in a Ugandan level two newborn unit.

BACKGROUND: Preterm birth and resulting respiratory failure is a leading cause of newborn death- the majority of which occur in resource-constrained settings and could be prevented with bubble continuous positive airway pressure (bCPAP). Commercialized devices are expensive, however, and sites commonly use improvised devices utilizing 100% oxygen which can cause blindness. To address this, PATH and a multidisciplinary team developed a very low-cost bCPAP device including fixed-ratio oxygen blenders. OBJECTIVE: We assessed feasibility of use of the device on neonatal patients as well as the usability and acceptability of the device by healthcare workers. This study did not evaluate device effectiveness. METHODS: The study took place in a Ugandan level two unit. Neonates with respiratory failure were treated with the bCPAP device. Prospective data were collected through observation as well as likert-style scales and interviews with healthcare workers. Data were analyzed using frequencies, means and standard deviation and interviews via a descriptive coding method. Retrospectively registered via ClinicalTrials.gov number NCT05462509. RESULTS: Fourteen neonates were treated with the bCPAP device in October-December 2021. Patients were born onsite (57%), with median weight of 1.3 kg (IQR 1-1.8). Median treatment length was 2.5 days (IQR 2-6). bCPAP was stopped due to: improvement (83%) and death (17%). All patients experienced episodes of saturations >95%. Median time for device set up: 15 minutes (IQR 12-18) and changing the blender: 15 seconds (IQR 12-27). After initial device use, 9 out of 9 nurses report the set-up as well as blender use was "easy" and their overall satisfaction with the device was 8.5/10 (IQR 6.5-9.5). Interview themes included the appreciation for the ability to administer less than 100% oxygen, desire to continue use of the device, and a desire for additional blenders. CONCLUSIONS: In facilities otherwise using 100% oxygen, use of the bCPAP device including oxygen blenders is feasible and acceptable to healthcare workers. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier NCT05462509.

Performance of the woman's condom among couples in Shanghai, China.

BACKGROUND: The Woman's Condom, a second-generation female condom, is poised for introduction in China. STUDY DESIGN: This single-arm couples' use study was conducted in China in 2010 to assess performance and safety of the Woman's Condom and feasibility of mobile phone technology to record adherence data. RESULTS: Sixty couples were enrolled in this study, and 59 couples completed all four of the condom uses, resulting in 234 condom uses. Two condoms were opened but not used. Total breakage was 0.85% (two non-clinical breakages). Misdirection (2%), invagination (0.85%) and slippage (1%) were consistent with data on condom failure from other studies. Total clinical failure was 4%. Fifteen mild and no serious adverse events were reported during the study. CONCLUSIONS: This study has shown that in China, the Woman's Condom performs well. Mobile phones cannot yet replace the use of a coital log and questionnaire. Further work on effectiveness is required.

Nonclinical Bench Performance Testing of a Very Low-Cost Nonelectric Bubble Continuous Positive Airway Pressure (bCPAP) and Blenders Device Designed for Newborn Respiratory Support.

Purpose: Bubble continuous positive airway pressure (bCPAP) is often used to treat respiratory distress experienced by some 15 million preterm infants born globally every year. In low- and middle-income countries, improvised bCPAP devices are used, often without a blender that protects the infant from the sequelae of excessive oxygen exposure. Materials and Methods: The aim of this bench testing was to assess the mechanical safety and performance of the PATH bCPAP and blenders device, which provides a stable and reliable source of pressurized blended gas without the requirement for a source of compressed medical air or electricity. The device includes two fixed ratio blenders: a "low" blend that provides 37% oxygen and a "high" blend that provides 60% oxygen. We performed bench testing to characterize the performance of the bCPAP and blenders, including respiratory circuit verification, blender verification, conditioned humidity testing, and sound measurement. Results: Test results for all performance variables met the acceptance criteria of our product requirement specification. The device provides a fixed ratio of air and oxygen that is consistent over the entire range of clinically relevant pressures (4 to 8 cmH2O) and remains consistent despite changes in flow (2 to 7 liters per minute). The blend is stable within ± 5% of the blenders' nominal blend ratio when used with a 100% oxygen source, irrespective of the flow and pressure from the oxygen source or the flow and pressure of the blended gas delivered to the neonate. Sound and humidity test results were within specifications. Conclusion: This very low-cost nonelectric bCPAP and blenders device is optimally designed to deliver a stable and reliable source of pressurized blended gas.

Establishing a Health Information Technology for the Vaccination of National Institutes of Health Staff.

Introduction: Healthcare organizations faced unique operational challenges during the COVID-19 pandemic. Assuring the safety of both patients and healthcare workers in hospitals has been the primary focus during the COVID-19 pandemic. Methods: The NIH Vaccine Program (VP) with the Vaccine Management System (VMS) was created based on the commitment of NIH leadership, program leadership, the development team, and the program team; defining Key Performance Indicators (KPIs) of the VP and the VMS; and the NIH Clinical Center's (NIH CC) interdisciplinary approach to deploying the VMS. Results: This article discusses the NIH business requirements of the VP and VMS, the target KPIs of the VP and the VMS, and the NIH CC interdisciplinary approach to deploying an organizational VMS for vaccinating the NIH workforce. The use of the DCRI Spiral-Agile Software Development Life Cycle enabled the development of a system with stakeholder involvement that could quickly adapt to changing requirements meeting the defined KPIs for the program and system. The assessment of the defined KPIs through a survey and comments from the survey support that the VP and VMS were successful. Conclusion: A comprehensive program to maintain a healthy workforce includes asymptomatic COVID testing, symptomatic COVID testing, contact tracing, vaccinations, and policy-driven education. The need to develop systems during the pandemic resulted in changes to build software quickly with the input of many more users and stakeholders then typical in a decreased amount of time.

Unveiling the silent threat among us: leveraging health information technology in the search for asymptomatic COVID 19 healthcare workers.

Assuring the safety of both patients and healthcare workers (HCWs) in hospitals has been the primary focus of every healthcare organization during the COVID 19 pandemic. This article discusses the NIH Clinical Center's interdisciplinary approach to deploying an organizational Asymptomatic Staff Testing System.

Improving quality of prevention of mother-to-child HIV transmission services in Ukraine: a focus on provider communication skills and linkages to community-based non-governmental organizations.

BACKGROUND: Ukraine has the highest rate of HIV infection in Europe, with an estimated adult prevalence of 1.6 percent. The epidemic in Ukraine remains largely driven by injection drug use, and women of reproductive age are being increasingly affected. Prior research has highlighted the need to improve the quality of services for prevention of mother-to-child transmission (PMTCT) and to address other issues related to HIV counseling, testing, and care, especially in the context of antenatal and obstetric services. METHODS: From 2004 to 2007, PATH led a collaborative effort to improve the quality of PMTCT services in Ukraine. Initial assessments included focus groups with Ukrainian women and review of existing educational materials. Interventions focused on training providers to improve skills in communication and referral to community-based support; they also addressed the underlying issue of stigma. RESULTS: Observational data demonstrated that providers who participated in the training intervention delivered PMTCT counseling of a consistently higher quality than did providers who did not undergo training. Exit interviews with clients confirmed these findings. CONCLUSIONS: An intervention focused on strengthening voluntary counseling and testing for HIV, forging partnerships with local organizations, and undoing HIV-related stigma can help to improve access to and quality of PMTCT services in antenatal care clinics.

A randomized crossover trial comparing the Nifty cup to a medicine cup in preterm infants who have difficulty breastfeeding at Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana.

INTRODUCTION: Preterm infants make up the majority of the 9 million babies born in Africa and South Asia requiring supplemental feedings as they transition to exclusive breastfeeding. The World Health Organization recommends the use of a cup to feed newborns with breastfeeding difficulties in low-resource settings. We set out to evaluate the Nifty cup, a new feeding cup designed specifically for infants with breastfeeding difficulties. MATERIALS AND METHODS: We conducted a randomized clinical trial in Ghana. We hypothesized infants would prefer the Nifty cup and that it would have less spillage as compared to a medicine cup. We enrolled mothers and preterm infants with breastfeeding difficulties indicated to cup feed at Komfo Anokye Teaching Hospital. Each mother-infant pair used the Nifty cup and a standard medicine cup; and two feeding assessments with each cup were conducted. We employed an intent-to-treat analysis comparing cup preference using a Wilcoxon signed rank test and spillage using generalized estimating equations. RESULTS: We enrolled 200 mothers and 237 infants. Many infants were very low birth weight (62%), less than two weeks old (62%), and multiple birth (29%). In response to separate questions about each cup, more mothers reported liking the Nifty cup a lot as compared to the medicine cup (85% versus 57%, p<0.001). When asked to choose between the two cups, more than 75% preferred the Nifty cup (p < 0.001). There was slightly less spillage with the Nifty cup (8.9%) versus the medicine cup (9.3%), which was not statistically significant (p = 0.35). Mothers reported greater confidence and ease of using the Nifty cup and greater use one-month post-discharge compared to the medicine cup (p-values <0.001). Nearly all mothers were breastfeeding and cup feeding their infants at study initiation and at one-month post-discharge. DISCUSSION: This is the first randomized clinical trial of cup feeding in sub-Saharan Africa. Mothers prefer the Nifty cup to a medicine cup for supplemental feeds to their preterm infant. The Nifty cup was used with greater ease and confidence. The Nifty cup can offer an improved feeding experience for the mother-infant pair.