The provision of the baby box was associated with safe sleep practices in a low-resource community: a randomized control trial in Ecuador.

BACKGROUND: Sudden Unexpected Infant Deaths (SUID) can occur between 1 month and 1 year of age and are inequitably distributed with a greater burden in populations with numerous health disparities. Modifying the infant sleep environment to promote safe sleep is the most effective risk reduction strategy to reduce SUID. The provision of baby boxes with a mattress and infant supplies has been part of a larger anti-poverty social justice maternity package for decades in Finland. While infant mortality rates have generally improved after the maternity package was introduced, little is known about whether the provision of the baby box increased safe sleep practices. The purpose of the study was to evaluate whether the provision of a Finnish-style baby box reinforced safe infant sleep practice in the home in a low-resource community in Ecuador. METHODS: In this longitudinal randomized controlled trial all participants received the same safe sleep education in their third trimester of pregnancy (n = 100). This was followed by randomization into two groups; the control received a diaper bag and newborn gifts, and the intervention group received a baby box and the same gifts at each timepoint. Four infant sleep practices (room sharing, bed sharing/co-sleeping, position, and soft items in the sleep environment) were assessed at 1 month and 1 months post-delivery during a home visit where safe sleep education was also reinforced with both groups. RESULTS: Those in the baby box group were 2.5 times more likely to report safe sleep practices compared with mothers in the diaper bag group at 1 month (odds ratio [OR] = 2.45 and 95% confidence interval [CI]: 1.03-5.86; χ2 = 4.1, p = .043). The group difference was also present at 6-months post-birth: those in the baby box group were 2.9 times more likely to report safe sleep practices compared with those in the diaper bag group (OR = 2.86 and 95% CI: 1.16-7.05; χ2 = 5.2, p = .022). CONCLUSIONS: While not all participants used the box regularly, the mothers who received the box were more likely to practice safe sleep at 1 month and 6 months. This suggests the baby box may have served as an important prompt towards safer infant sleep practice. TRIAL REGISTRATION: (Clinical Trial Registry, per clinicaltrials.gov : not applicable under 42 CFR 11.22(b) as the study Facility Location was not in the United States (took place in Ecuador), does not involve FDA IND or IDE, and does not involve a drug, biological or device product that is manufactured in and exported from the US for study in another country. The University of San Francisco Quito, Research Ethics Committee in Human Beings approved the study, #2017- 127 M. The University of Kentucky Office of Research Integrity also approved the study, IRB # 42965).

Poverty and Paternal Education Associated With Infant Safe Sleep Intentions in a Peri-Urban Community in Ecuador.

Ecuador's annual mortality rate from SIDS is 0.4 per 100 000 people, 4 times higher than neighboring countries Peru, Bolivia, and Brazil. Modifying the infant sleep environment toward safe practice has been demonstrated to be the most effective risk reduction strategy in reducing mortality from SIDS and little is known about sleep practices in Ecuador. The purpose of this study is to describe baseline infant sleep intentions of pregnant women in a peri-urban, low resource community in Ecuador. We also aim to identify demographic and psychosocial factors associated with suboptimal sleep practices in this context to develop long-term strategies to identify infants with high risk for SIDS/SUID. A cross-sectional study design was employed with 100 women in their third trimester of pregnancy. The majority of women were partnered (82%), both parents had approximately 8 years of education, and over half reported that their incomes met or exceeded their basic needs (55%). Significant predictors of safer sleep intention included years of paternal education (P = .019) and income meeting their basic needs (P = .0049). For each additional year of paternal education, families were 23% more likely to report safer intended infant sleep practices. Compared to those whose income did not allow for basic needs, those who had sufficient income to meet (or exceed) basic needs were 425% more likely to report safer intended sleep practices. Targeted interventions to high-risk populations may reduce the burden of SIDS/SUID in this community.

Potential applications for rhIGF-I: Bone disease and IGFI.

Growth hormone (GH) and insulin like growth factor-I (IGFI) are key bone trophic hormones, whose rising levels during puberty are critical for pubertal bone accrual. Conditions of GH deficiency and genetic resistance impact cortical and trabecular bone deleteriously with reduced estimates of bone strength. In humans, conditions of undernutrition (as in anorexia nervosa (AN), or subsequent to chronic illnesses) are associated with low IGF-I levels, which correlate with disease severity, and also with lower bone mineral density (BMD), impaired bone structure and lower strength estimates. In adolescents and adults with AN, studies have demonstrated a nutritionally acquired GH resistance with low IGF-I levels despite high concentrations of GH. IGF-I levels go up with increasing body weight, and are associated with rising levels of bone turnover markers. In short-term studies lasting 6-10 days, recombinant human IGF-I (rhIGF-I) administration in physiologic replacement doses normalized IGF-I levels and increased levels of bone formation markers in both adults and adolescents with AN. In a randomized controlled trial in adults with AN in which participants were randomized to one of four arms: (i) rhIGF-I with oral estrogen-progesterone (EP), (ii) rhIGF-I alone, (iii) EP alone, or (iv) neither for 9 months, a significant increase in bone formation markers was noted in the groups that received rhIGF-I, and a significant decrease in bone resorption markers in the groups that received EP. The group that received both rhIGF-I and EP had a significant increase in bone density at the spine and hip compared to the group that received neither. Side effects were minimal, with no documented fingerstick glucose of <50 mg/dl. These data thus suggest a potential role for rhIGF-I administration in optimizing bone accrual in states of undernutrition associated with low IGF-I.

Development and Initial Validation of a Frontline Health Worker mHealth Assessment Platform (MEDSINC®) for Children 2-60 Months of Age.

Approximately 3 million children younger than 5 years living in low- and middle-income countries (LMICs) die each year from treatable clinical conditions such as pneumonia, dehydration secondary to diarrhea, and malaria. A majority of these deaths could be prevented with early clinical assessments and appropriate therapeutic intervention. In this study, we describe the development and initial validation testing of a mobile health (mHealth) platform, MEDSINC®, designed for frontline health workers (FLWs) to perform clinical risk assessments of children aged 2-60 months. MEDSINC is a web browser-based clinical severity assessment, triage, treatment, and follow-up recommendation platform developed with physician-based Bayesian pattern recognition logic. Initial validation, usability, and acceptability testing were performed on 861 children aged between 2 and 60 months by 49 FLWs in Burkina Faso, Ecuador, and Bangladesh. MEDSINC-based clinical assessments by FLWs were independently and blindly correlated with clinical assessments by 22 local health-care professionals (LHPs). Results demonstrate that clinical assessments by FLWs using MEDSINC had a specificity correlation between 84% and 99% to LHPs, except for two outlier assessments (63% and 75%) at one study site, in which local survey prevalence data indicated that MEDSINC outperformed LHPs. In addition, MEDSINC triage recommendation distributions were highly correlated with those of LHPs, whereas usability and feasibility responses from LHP/FLW were collectively positive for ease of use, learning, and job performance. These results indicate that the MEDSINC platform could significantly increase pediatric health-care capacity in LMICs by improving FLWs' ability to accurately assess health status and triage of children, facilitating early life-saving therapeutic interventions.

Insulin resistance depends on GH counter-regulation in two syndromes of short stature.

Specific phenotypic features of subjects affected with genetic syndromes depend on peculiarities of expression of each discrete mutation and on extent of its divergence from normal physiology. In this context, and when studying the GH/IGF-I axis of subjects with two different syndromes that include severe short stature (SSS), we noticed different metabolic phenotypes in each cohort. Subjects with Laron syndrome (LS), who have GH insensitivity (GHI), display obesity, increased body fat, enhanced insulin sensitivity and diminished incidence of diabetes mellitus. Subjects with a new syndrome (NS), who have normal GH signaling, display intrauterine growth retardation (IUGR), normal to slightly elevated body fat content, insulin resistance and early onset type 2 diabetes mellitus (T2DM). In consequence, we were able to observe the clinical consequences of different GH counter-regulation status on carbohydrate metabolism, especially considering that subjects with either syndrome most likely have diminished pancreatic reserve.