Breastfeeding and Once-Daily Small-Volume Formula Supplementation to Prevent Infant Growth Impairment.

BACKGROUND: Randomized controlled trials in Guinea-Bissau and Uganda have revealed that the intensive promotion of exclusive breastfeeding (EBF) impairs growth in early infancy. When newborn growth is impaired, small amounts of formula may be combined with breastfeeding to promote growth. METHODS: To determine if breastfeeding combined with once-daily formula supplementation improves growth among at-risk newborns, we conducted a pilot randomized controlled trial in Bissau, Guinea-Bissau and Kampala, Uganda. We randomly assigned 324 healthy breastfeeding newborns who weighed 2000 g to 2499 g at birth or <2600 g at 4 days old to once-daily formula feeding through 30 days as a supplement to frequent breastfeeding followed by EBF from 31 days through 6 months, or to EBF through 6 months. The primary outcome was weight-for-age z score (WAZ) at 30 days. Other outcomes included weight-for-length z score (WLZ), length-for-age z score (LAZ), breastfeeding cessation, adverse events, and serious adverse events through 180 days. RESULTS: Daily formula consumption in the intervention group was 31.9 ± 11.8 mL. The random assignment did not impact WAZ, WLZ, LAZ, breastfeeding cessation, adverse events, or serious adverse events through 180 days. In the intervention and control groups, 19 (12%) and 35 (21%) infants, respectively, reported nonformula supplementation in the first 30 days (P = .02). CONCLUSIONS: Once-daily formula supplementation for 30 days was well-tolerated, but the small volume consumed did not alter growth through 180 days of age. Further research would be required to determine if larger formula volumes, longer duration of treatment, or more frequent feeding are effective at increasing growth for this at-risk population.

Experiences and attitudes related to newborn feeding in central Uganda: A qualitative study.

OBJECTIVE: Adequate infant nutrition is a critical cornerstone of population health, yet adherence to recommended breastfeeding practices is low in many countries in sub-Saharan Africa, including Uganda. This study aims to describe local attitudes, experiences and beliefs related to nutrition in early infancy in Central Uganda. DESIGN: We conducted 5 focus group discussions and 12 key informant interviews to gather information on local attitudes, experiences and beliefs related to feeding in early infancy. SETTING: Urban areas of Central Uganda. PARTICIPANTS: Parents and healthcare and public health professionals. RESULTS: Participants reported numerous concerns related to infant health including inadequate infant weight, premature birth, diarrhea, fever, gastrointestinal infection and malnutrition. Awareness of the infant health benefits of exclusive breastfeeding was prevalent but experienced as in balance with maternal factors that might lead to supplementation, including employment demands, physical appearance, pain, poverty and maternal health and malnutrition. Breastfeeding was highly valued, but use of unsafe breast milk supplements was common, including cow's milk, black tea, glucose water, fruit juice, millet, maize, rice, potatoes, soy, sorghum, egg yolk, fish and ghee. Expression of breast milk was viewed as not consonant with local culture. CONCLUSIONS: Participants were aware of the benefits of exclusive breastfeeding but described multiple barriers to achieving it. Supplementation with unsafe breastmilk supplements was considered to be more culturally consonant than milk expression and was reported to be the only affordable potential breast milk substitute for many families.

Randomized controlled trial of early, small-volume formula supplementation among newborns: A study protocol.

Childhood undernutrition is a major health burden worldwide that increases childhood morbidity and mortality and causes impairment in infant growth and developmental delays that can persist into adulthood. The first weeks and months after birth are critical to the establishment of healthy growth and development during childhood. The World Health Organization recommends immediate and exclusive breastfeeding (EBF). In infants for whom EBF may not meet nutritional and caloric demands, early, daily, small-volume formula supplementation along with breastfeeding may more effectively avoid underweight wasting and stunting in early infancy than breastfeeding alone. The primary objective of this randomized controlled trial is to evaluate the efficacy of formula for 30 days among low birth weight (LBW) infants <6 hours of age and those not LBW with weights <2600 grams at 4 days of age. We will compare breastfeeding and formula (up to 59 milliliters administered daily) through 30 days of infant age vs recommendations for frequent EBF without supplementation, and test the hypothesis that formula increases weight-for-age z-score at 30 days of infant age. The trial will enroll and randomize 324 mother-infant pairs in Guinea-Bissau and Uganda, and follow them for 6 months for outcomes including growth, intestinal microbiota, breastfeeding duration, infant dietary intake, and adverse events. Conservatively estimating 20% loss to follow up, this sample size provides ≥80% power per weight stratum for intervention group comparison to detect a difference of 0.20 with respect to the outcome of WAZ at day 30. This trial was approved by the University of California, San Francisco Institutional Review Board (19-29405); the Guinea-Bissau National Committee on Ethics in Health (Comite Nacional de Etica na Saude, 075/CNES/INASA/2020); the Higher Degrees, Research and Ethics Committee of Makerere University (871); and the Uganda National Council of Science and Technology (HS1226ES). We plan to disseminate study results in peer-reviewed journals and international conferences. Trial registration number: NCT04704076.

"The cord is the child": meanings and practices related to umbilical cord care in Central Uganda.

BACKGROUND: Infections account for a quarter of all newborn deaths and the umbilical cord has been identified as a major route of newborn infections. OBJECTIVE: To explore the meanings and practices related to the umbilical cord among caretakers of newborns in central Uganda. METHODS: This was a qualitative study, designed to inform the design, and interpretation of a randomized controlled trial assessing the effectiveness of chlorhexidine use for the umbilical cord. We conducted 22 in-depth interviews exploring umbilical cord care practices among ten mothers, four health workers, five traditional birth attendants, and three men. We also conducted three focus group discussions with young mothers and elderly women. We used qualitative content analysis to analyze our findings and we borrow upon Mary Douglas' concepts of dirt to present our findings. RESULTS: The umbilical cord had a symbolic position in newborn care. The way it was perceived and handled had far reaching consequences for the survival and wellbeing of the baby. The umbilical cord was a centre of anxiety, a possible gate to illness, a test of fatherhood and a signifier of parental responsibility. Hence, the umbilical cord and the way it was cared for played a part in the present and future survival of the baby, as well as the survival and wellbeing of the household. Persons other than the mother such as older female relatives were very influential in the care of the umbilical cord. CONCLUSIONS: The umbilical cord carried symbolic meanings, which extended beyond the newborn and the newborn period, and in turn influenced the various practices of umbilical cord care. The important position of the cord in local newborn care practices should be recognized and taken into consideration when scaling up newborn care interventions in the country.

Key Decision Makers and Actors in Selected Newborn Care Practices: A Community-Based Survey in Northern Uganda.

Knowledge of key decision makers and actors in newborn care is necessary to ensure that health interventions are targeted at the right people. This was a cross-sectional study carried out in Lira district, Northern Uganda. Multivariable logistic regression was used to determine factors associated with mothers being the key decision maker regarding where to give birth from and when to initiate breastfeeding. Fathers were the key decision makers on the place of birth (54.3%, n = 505) and on whether to seek care for a sick newborn child (47.7%, n = 92). Grandmothers most commonly bathed the baby immediately after birth (55.5%, n = 516), whereas mothers and health workers were common decision makers regarding breastfeeding initiation. Predictors for a mother being the key decision maker on the place of birth included: Mother having a secondary education (AOR 1.9: 95% C.I (1.0-3.6)) and mother being formally employed (AOR 2.0: 95% (1.5-2.9)). Mothers, fathers, grandmothers, health-workers, and traditional birth attendants were the most influential in the selected newborn care practices. Programs that aim to promote newborn care need to involve husbands, grandmothers, and health workers in addition to mothers.

"We shall count it as a part of kyogero": acceptability and considerations for scale up of single dose chlorhexidine for umbilical cord care in Central Uganda.

BACKGROUND: Cleansing the umbilical cord with chlorhexidine reduces neonatal morbidity and mortality, particularly in communities where newborn deaths and home births are common. As a result, the World Health Organization and national authorities are advocating the scale up of this intervention. In order for such a scale up to be effective, it has to be acceptable to the targeted population. With the overall aim to clarify conditions for scale-up, this study explored the acceptability of single dose chlorhexidine solution for umbilical cord care among health workers and infant care providers in the districts of Kampala and Mukono in Central Uganda. METHODS: This was a qualitative study that involved mothers of neonates enrolled in a chlorhexidine trial, nurses implementing the trial, key community members and opinion leaders in childcare. We conducted 30 in depth interviews (IDIs) with mothers (18), health workers (8), traditional birth attendants (2), a father (1) and a grandmother (1) and 4 focus group discussions (FGDs), 3 with mothers and 1 with health workers. We used qualitative content analysis to analyze our findings and borrow upon Sekhon's model when presenting our findings. RESULTS: Cognitive and emotional responses to chlorhexidine use included ease of use, and a perception that chlorhexidine reduced smell and abdominal colic. We also found that wider social and cultural factors were important to chlorhexidine use. These included cultural value put on quick separation of the umbilical cord as well as the practice of bathing the baby in a herbal mixture called kyogero. We also found that older relatives were key decision makers in umbilical cord care for newborns, but were seldom present during health workers' counseling of mothers about hygienic care of the cord. CONCLUSIONS: The application of chlorhexidine on the umbilical cord stump at birth was acceptable as an addition rather than a total replacement of traditional substances. The scale up of chlorhexidine should consider how to accommodate local beliefs and practices in a way that does not compromise the effect of the intervention; encouraging mothers to delay the bathing of babies in kyogero could be one way of doing this.

Zinc adjunct therapy reduces case fatality in severe childhood pneumonia: a randomized double blind placebo-controlled trial.

BACKGROUND: Pneumonia is a leading cause of children's deaths in developing countries and hinders achievement of the fourth Millennium Development Goal. This goal aims to reduce the under-five mortality rate, by two thirds, between 1990 and 2015.Few studies have examined the impact of zinc adjunct therapy on the outcome of childhood pneumonia. We determined the effect of zinc as adjunct therapy on time to normalization of respiratory rate, temperature and oxygen saturation. We also studied the effect of zinc adjunct therapy on case fatality of severe childhood pneumonia (as a secondary outcome) in Mulago Hospital, Uganda. METHODS: In this double blind, randomized, placebo-controlled clinical trial, 352 children aged 6 to 59 months, with severe pneumonia were randomized to zinc (20 mg for children ≥ 12 months, and 10 mg for those < 12 months) or a placebo once daily for seven days, in addition to standard antibiotics for severe pneumonia. Children were assessed every six hours. Oxygen saturation was normal if it was above 92% (breathing room air) for more than 15 minutes. The respiratory rate was normal if it was consistently (more than 24 hours) below 50 breaths per minute in infants and 40 breaths per minute in children above 12 months of age. Temperature was normal if consistently below 37.5°C. The difference in case fatality was expressed by the risk ratio between the two groups. RESULTS: Time to normalization of the respiratory rate, temperature and oxygen saturation was not significantly different between the two arms.Case fatality was 7/176 (4.0%) in the zinc group and 21/176 (11.9%) in the placebo group: Relative Risk 0.33 (95% CI 0.15 to 0.76). Relative Risk Reduction was 0.67 (95% CI 0.24 to 0.85), while the number needed to treat was 13. Among HIV infected children, case fatality was higher in the placebo (7/27) than in the zinc (0/28) group; RR 0.1 (95% CI 0.0, 1.0).Among 127 HIV uninfected children receiving the placebo, case fatality was 7/127 (5.5%); versus 5/129 (3.9%) among HIV uninfected group receiving zinc: RR 0.7 (95% CI 0.2, 2.2). The excess risk of death attributable to the placebo arm (Absolute Risk Reduction or ARR) was 8/100 (95% CI: 2/100, 14/100) children. This excess risk was substantially greater among HIV positive children than in HIV negative children (ARR: 26 (95% CI: 9, 42) per 100 versus 2 (95% CI: -4, 7) per 100); P-value for homogeneity of risk differences = 0.006. CONCLUSION: Zinc adjunct therapy for severe pneumonia had no significant effect on time to normalization of the respiratory rate, temperature and oxygen saturation. However, zinc supplementation in these children significantly decreased case fatality.The difference in case fatality attributable to the protective effect of zinc therapy was greater among HIV infected than HIV uninfected children. Given these results, zinc could be considered for use as adjunct therapy for severe pneumonia, especially among Highly Active Antiretroviral Therapynaïve HIV infected children in our environment. CLINICAL TRIALS REGISTRATION NUMBER: clinicaltrials.gov NCT00373100.

Malaria parasitaemia among infants and its association with breastfeeding peer counselling and vitamin A supplementation: a secondary analysis of a cluster randomized trial.

BACKGROUND: Malaria is the second highest contributor to the disease burden in Africa and there is a need to identify low cost prevention strategies. The objectives of this study were to estimate the prevalence of malaria parasitaemia among infants and to measure the association between peer counselling for exclusive breastfeeding (EBF), vitamin A supplementation, anthropometric status (weight and length) and malaria parasitaemia. METHODS: A cluster randomized intervention trial was conducted between 2006 and 2008 where 12 of 24 clusters, each comprising one or two villages, in Eastern Uganda were allocated to receive peer counselling for EBF. Women in their third trimester of pregnancy (based on the last normal menstrual period) were recruited in all 24 clusters and followed up until their children's first birthday. Blood was drawn from 483 infants between 3 and 12 months of age, to test for malaria parasitaemia. RESULTS: The prevalence of malaria parasitaemia was 11% in the intervention areas and 10% in the control areas. The intervention did not seem to decrease the prevalence of malaria (PR 1.7; 95% CI: 0.9, 3.3). After controlling for potential confounders, infants not supplemented with Vitamin A had a higher prevalence for malaria compared to those who had been supplemented (PR 6.1; 95% CI: 2.1, 17.6). Among children supplemented with vitamin A, every unit increase in length-for-age Z (LAZ) scores was associated with a reduced prevalence in malaria (PR 0.5; 95% CI:0.4, 0.6). There was no association between LAZ scores and malaria among children that had not been supplemented. CONCLUSION: Peer counselling for exclusive breastfeeding did not decrease the prevalence of malaria parasitaemia. Children that had not received Vitamin A supplementation had a higher prevalence of malaria compared to children that had been supplemented. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00397150.

Is vaccination coverage a good indicator of age-appropriate vaccination? A prospective study from Uganda.

BACKGROUND: Timely vaccination is important to protect children from common infectious diseases. We assessed vaccination timeliness and vaccination coverage as well as coverage of vitamin A supplementation in a Ugandan setting. METHODS AND FINDINGS: This study used vaccination information gathered during a cluster-randomized trial promoting exclusive breastfeeding in Eastern Uganda between 2006 and 2008 (ClinicalTrials.gov no. NCT00397150). Five visits were carried out from birth up to 2 years of age (median follow-up time 1.5 years), and 765 children were included in the analysis. We used Kaplan-Meier time-to-event analysis to describe vaccination coverage and timeliness. Vaccination coverage at the end of follow-up was above 90% for all vaccines assessed individually that were part of the Expanded Program on Immunization (EPI), except for the measles vaccine which had 80% coverage (95%CI 76-83). In total, 75% (95%CI 71-79) had received all the recommended vaccines at the end of follow-up. Timely vaccination according to the recommendations of the Ugandan EPI was less common, ranging from 56% for the measles vaccine (95%CI 54-57) to 89% for the Bacillus Calmette-Guérin (BCG) vaccine (95%CI 86-91). Only 18% of the children received all vaccines within the recommended time ranges (95%CI 15-22). The children of mothers with higher education had more timely vaccination. The coverage for vitamin A supplementation at end of follow-up was 84% (95%CI 81-87). CONCLUSIONS: Vaccination coverage was reasonably high, but often not timely. Many children were unprotected for several months despite being vaccinated at the end of follow-up. There is a need for continued efforts to optimise vaccination timeliness.