Mixed-method study to assess the feasibility, acceptability and early effectiveness of the Hospital to Home programme for follow-up of high-risk newborns in a rural district of Central Uganda: a study protocol.

INTRODUCTION: A follow-up programme designed for high-risk newborns discharged from inpatient newborn units in low-resource settings is imperative to ensure these newborns receive the healthiest possible start to life. We aim to assess the feasibility, acceptability and early outcomes of a discharge and follow-up programme, called Hospital to Home (H2H), in a neonatal unit in central Uganda. METHODS AND ANALYSIS: We will use a mixed-methods study design comparing a historical cohort and an intervention cohort of newborns and their caregivers admitted to a neonatal unit in Uganda. The study design includes two main components. The first component includes qualitative interviews (n=60 or until reaching saturation) with caregivers, community health workers called Village Health Team (VHT) members and neonatal unit staff. The second component assesses and compares outcomes between a prospective intervention cohort (n=100, born between July 2019 and September 2019) and a historical cohort (n=100, born between July 2018 and September 2018) of infants. The historical cohort will receive standard care while the intervention cohort will receive standard care plus the H2H intervention. The H2H intervention comprises training for healthcare workers on lactation, breast feeding and neurodevelopmentally supportive care, including cue-based feeding, and training to caregivers on recognition of danger signs and care of their high-risk infants. Infants and their families receive home visits until 6 months of age, or longer if necessary, by specially trained VHTs. Quantitative data will be analysed using descriptive statistics and regression analysis. All results will be stratified by cohort group. Qualitative data will be analysed guided by Braun and Clarke's thematic analysis technique. ETHICS AND DISSEMINATION: This study protocol was approved by the relevant Ugandan ethics committees. All participants will provide written informed consent. We will disseminate through peer-reviewed publications and key stakeholders and public engagement. TRIAL REGISTRATION NUMBER: ISRCTN51636372; Pre-result

Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol.

INTRODUCTION: Early intervention programmes (EIPs) for infants with neurodevelopmental impairment have been poorly studied especially in low-income settings. We aim to evaluate the feasibility and acceptability of a group participatory EIP, the 'ABAaNA EIP', for young children with neurodevelopmental impairment in Uganda. METHODS AND ANALYSIS: We will conduct a pilot feasibility, single-blinded, randomised controlled trial comparing the EIP with standard care across two study sites (one urban, one rural) in central Uganda. Eligible infants (n=126, age 6-11 completed months) with neurodevelopmental impairment (defined as a developmental quotient <70 on Griffiths Scales of Mental Development, and, or Hammersmith Infant Neurological Examination score <60) will be recruited and randomised to the intervention or standard care arm. Intervention arm families will receive the 10-modular, peer-facilitated, participatory, community-based programme over 6 months. Recruited families will be followed up at 6 and 12 months after recruitment, and assessors will be blinded to the trial allocation. The primary hypothesis is that the ABAaNA EIP is feasible and acceptable when compared with standard care. Primary outcomes of interest are feasibility (number recruited and randomised at baseline) and acceptability (protocol violation of arm allocation and number of sessions attended) and family and child quality of life. Guided by the study aim, the qualitative data analysis will use a data-led thematic framework approach. The findings will inform scalability and sustainability of the programme. ETHICS AND DISSEMINATION: The trial protocol has been approved by the relevant Ugandan and UK ethics committees. Recruited families will give written informed consent and we will follow international codes for ethics and good clinical practice. Dissemination will be through peer-reviewed publications, conference presentations and public engagement. TRIAL REGISTRATION NUMBER: ISRCTN44380971; protocol version 3.0, 19th February 2018

Early care and support for young children with developmental disabilities and their caregivers in Uganda: The Baby Ubuntu feasibility trial.

Background: Early care and support provision for young children with developmental disabilities is frequently lacking, yet has potential to improve child and family outcomes, and is crucial for promoting access to healthcare and early education. We evaluated the feasibility, acceptability, early evidence of impact and provider costs of the Baby Ubuntu participatory, peer-facilitated, group program for young children with developmental disabilities and their caregivers in Uganda. Materials and methods: A feasibility trial, with two parallel groups, compared Baby Ubuntu with standard care. Caregivers and children, aged 6-11 months with moderate-severe neurodevelopmental impairment, were recruited and followed for 12 months. Quantitative and qualitative methods captured information on feasibility (ability to recruit), acceptability (satisfactory attendance), preliminary evidence of impact (family quality of life) and provider costs. Results: One hundred twenty-six infants (median developmental quotient, 28.7) were recruited and randomized (63 per arm) over 9 months, demonstrating feasibility; 101 (80%) completed the 12-month follow-up assessment (9 died, 12 were lost to follow up, 4 withdrew). Of 63 randomized to the intervention, 59 survived (93%); of these, 51 (86%) attended ≥6 modules meeting acceptability criteria, and 49 (83%) completed the 12 month follow-up assessment. Qualitatively, Baby Ubuntu was feasible and acceptable to caregivers and facilitators. Enabling factors included community sensitization by local champions, positive and caring attitudes of facilitators toward children with disability, peer support, and the participatory approach to learning. Among 101 (86%) surviving children seen at 12 months, mixed methods evaluation provided qualitative evidence of impact on family knowledge, skills, and attitudes, however impact on a scored family quality of life tool was inconclusive. Barriers included stigma and exclusion, poverty, and the need to manage expectations around the child's progress. Total provider cost for delivering the program per participant was USD 232. Conclusion: A pilot feasibility trial of the Baby Ubuntu program found it to be feasible and acceptable to children, caregivers and healthcare workers in Uganda. A mixed methods evaluation provided rich programmatic learning including qualitative, but not quantitative, evidence of impact. The cost estimate represents a feasible intervention for this vulnerable group, encouraging financial sustainability at scale. Clinical trial registration: [https://doi.org/10.1186/ISRCTN44380971], identifier [ISRCTN44380971]

Delayed initiation of enteral feeds is associated with postnatal growth failure among preterm infants managed at a rural hospital in Uganda

Background: Prematurity is the leading cause of mortality in children under 5 years of age globally and is also frequently associated with postnatal growth failure (PGF). Although most preterm births occur in low resource settings, little is known about their postnatal growth outcomes especially in rural areas. We evaluated the incidence and factors associated with PGF among preterm infants managed at a rural hospital in Uganda. Methods: Retrospective cohort study of preterm infants discharged from Kiwoko Hospital neonatal intensive care unit (NICU) from July 2017 to June 2018. Inclusion criteria included gestational age 26 up to but not including 37 weeks, admission within 24 h of birth and at least 7 days hospital stay. Exclusion criteria included major congenital anomalies and missing gestational age or birth weight. Birth and discharge weights from clinical notes were plotted on Fenton 2013 growth charts. Gestation age was determined by last normal menstruation period (LNMP), extracted from the mother’s antenatal card or early obstetric ultrasound scan reports. Postnatal growth failure was diagnosed if discharge weight was less than the 10th percentile for estimated gestational age. Other data from the clinical notes included demographic characteristics, neonatal morbidities as assigned by the attending physician and infant feeding practices. Multivariable logistic regression was used to explore factors associated with PGF. Results: A total of 349 preterm infants with a mean gestational age of 31 (range 26 to 36) weeks were included. The incidence proportion of PGF was 254/349 (73%). Factors significantly associated with postnatal growth failure included: delayed initiation of enteral feeds [AOR = 3.70, 95% (CI 1.64 to 8.33)], sepsis [AOR = 6.76, 95% (CI 2.15 to 21.2)], multiple gestation [AOR = 1.81, 95% (CI 1.01 to 3.24)] and male gender [AOR = 1.71 95% (CI 1.01 to 2.91)]. Conclusion: Nearly three quarters of preterm infants managed at a rural hospital in Uganda had postnatal growth failure. Delayed initiation of enteral feeds and sepsis were highly associated with postnatal growth failure. Enteral feeds should be initiated as soon as possible in these infants to reduce early protein deficits and hence postnatal growth failure

Outborn newborns drive birth asphyxia mortality rates-An 8 year analysis at a rural level two nursery in Uganda.

Birth asphyxia is a leading cause of global neonatal mortality. Most cases occur in low- and middle- income countries and contribute to half of neonatal deaths in Uganda. Improved understanding of the risk factors associated with mortality among these patients is needed. We performed a retrospective cohort study of a clinical database and report maternal demographics, clinical characteristics and outcomes from neonates with birth asphyxia at a Ugandan level two unit from 2014 through 2021. "Inborn" patients were born at the hospital studied and "outborn" were born at another facility or home and then admitted to the hospital studied. Doctors assigned the patient's primary diagnosis at death or discharge. We performed a Poisson model regression of factors associated with mortality among patients with asphyxia. The study included 1,565 patients with birth asphyxia and the proportion who were outborn rose from 26% to 71% over eight years. Mortality in asphyxiated patients increased over the same period from 9% to 27%. Factors independently associated with increased death included outborn birth location (ARR 2.1, p8.3 mmol/L (RR 1.7, p60bpm was protective against death (ARR 0.6, p<0.05). Increased birth asphyxia mortality at this referral unit was associated with increasing admission of outborn patients. Patients born at another facility and transferred face unique challenges. Increased capacity building at lower-level birth facilities could include improved staffing, training and equipment for labor monitoring and newborn resuscitation as well as training on the timely identification of newborns with birth asphyxia and resources for transfer. These changes may reduce incidence of birth asphyxia, improve outcomes among birth asphyxia patients and help meet global targets for newborn mortality

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

BackgroundPreterm 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.ObjectiveWe 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.MethodsThe 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.ResultsFourteen 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.ConclusionsIn facilities otherwise using 100% oxygen, use of the bCPAP device including oxygen blenders is feasible and acceptable to healthcare workers.Trial registrationClinicalTrials.gov, Identifier NCT05462509

Prevalence and pattern of retinopathy of prematurity at two national referral hospitals in Uganda : a cross-sectional study

Abstract: Background Retinopathy of prematurity (ROP) is a leading cause of blindness in children and an ROP epidemic is predicted this decade in sub-Saharan Africa. With the increasing survival rate of preterm babies in Uganda, and no data on ROP prevalence, there is a need to assess the burden of ROP to inform preventive strategies and targeted screening.Methods We conducted a two-center cross-sectional study of preterm (< 37 weeks gestational age) infants from the neonatal units of Kawempe National Referral Hospital (KNRH) and Mulago Specialised Women and Neonatal Hospital (MSWNH) from August 2022 to October 2022. An ophthalmologist examined all participants using an indirect ophthalmoscope with a + 20D convex lens and captured digital images using a Volk iNview (TM) Fundus Camera. The collected data were entered into Epidata 4.2 and exported to Stata 14.0 for analysis.Results 331 preterm infants enrolled in this study. The oxygen received was unblended. The mean gestational age was 30.4 +/- 2.7 weeks, and the mean birth weight was 1597 +/- 509 g. 18/101 (17.8%) were found to have any ROP amongst the preterm infants recruited from MSWNH, 1/230 (0.4%) from KNRH [95% CI] had any stage of ROP (i.e. stage 5). Of these, 8 (42.1%) had stage 2 ROP. Infants with a birth weight below 1500 g were 10 times more likely to have ROP than those among infants with a birth weight more than 1500 g [AOR: 10.07 (2.71-37.44)]. Infants who were not fed exclusively on breast milk had higher odds of having ROP than those exclusively fed on breast milk [AOR: 7.82(1.92-31.82)].Conclusion 6% of preterm infants born in two tertiary hospitals in Uganda were found to have ROP. Lack of exclusive feeding on breast milk and birth weight of less than 1500 g were strong predictors of ROP. The higher prevalence of ROP in MSWNH calls for cautious use of oxygen among preterms. We recommend targeted ROP screening for those at risk