scholarly journals Single-dose azithromycin for child growth in Burkina Faso: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ali Sié ◽  
Boubacar Coulibaly ◽  
Clarisse Dah ◽  
Mamadou Bountogo ◽  
Mamadou Ouattara ◽  
...  
Keyword(s):  
Single Dose ◽  
Weight Gain ◽  
Burkina Faso ◽  
Controlled Trial ◽  
Population Sample ◽  
Child Growth ◽  
Mean Difference ◽  
Antibiotic Administration ◽  
Linear Regression Models ◽  
Randomized Controlled

Abstract Background In lower resource settings, previous randomized controlled trials have demonstrated evidence of increased weight gain following antibiotic administration in children with acute illness. We conducted an individually randomized trial to assess whether single dose azithromycin treatment causes weight gain in a general population sample of children in Burkina Faso. Methods Children aged 8 days to 59 months were enrolled in November 2019 and followed through June 2020 in Nouna Town, Burkina Faso. Participants were randomly assigned to a single oral dose of azithromycin (20 mg/kg) or matching placebo. Anthropometric measurements were collected at baseline and 14 days and 6 months after enrollment. The primary anthropometric outcome was weight gain velocity in g/kg/day from baseline to 14 days and 6 months in separate linear regression models. Results Of 450 enrolled children, 230 were randomly assigned to azithromycin and 220 to placebo. Median age was 26 months (IQR 16 to 38 months) and 51% were female. At 14 days, children in the azithromycin arm gained a mean difference of 0.9 g/kg/day (95% CI 0.2 to 1.6 g/kg/day, P = 0.01) more than children in the placebo arm. There was no difference in weight gain velocity in children receiving azithromycin compared to placebo at 6 months (mean difference 0.04 g/kg/day, 95% CI − 0.05 to 0.13 g/kg/day, P = 0.46). There were no significant differences in other anthropometric outcomes. Conclusions Transient increases in weight gain were observed after oral azithromycin treatment, which may provide short-term benefits. Clinical trials registration ClinicalTrials.gov NCT03676751. Registered 19/09/2018.

scholarly journals Short-term weight gain among preschool children in rural Burkina Faso: a secondary analysis of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029634 ◽  
Author(s):  
Elena G Dennis ◽  
Ali Sie ◽  
Lucienne Ouermi ◽  
Clarisse Dah ◽  
Charlemagne Tapsoba ◽  
...  
Keyword(s):  
Weight Gain ◽  
Randomised Controlled Trial ◽  
Food Insecurity ◽  
Burkina Faso ◽  
Controlled Trial ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Short Term ◽  
Randomised Controlled ◽  
Socioeconomic And Demographic Factors

ObjectivesNutrition has profound effects on children’s health outcomes and is linked to weight gain and cognitive development. We used data from a randomised controlled trial to evaluate the prospective associations between dietary, socioeconomic and demographic factors and short-term weight gain during the lean season in a rural area of Burkina Faso.DesignProspective cohort data arising from a randomised controlled trial of the effect of antibiotic distribution on child growth and intestinal microbial diversity.SettingTwo rural communities in Nouna District, Burkina Faso.Participants246 children aged 6–59 months living in the study communities were enrolled in the study.Primary and secondary outcome measuresAnthropometric measurements, including weight and height, were obtained at baseline and 1 month.ResultsOf 246 children, the median weight for wasted children at baseline (weight-for-height z-score <−2) was 9.7 kg (IQR 8.65–10.8) and the weight of non-wasted children was 12.8 kg (IQR 10.9–14.75). Food insecurity was significantly associated with decreased weight gain velocity (mean difference −0.03 g/kg/day, 95% CI −0.06 to −0.006, p=0.04).ConclusionExperiences of household food insecurity before the beginning of the lean season were associated with decreased weight gain in children in rural Burkina Faso during the lean season, although the mean difference was small. Understanding the relationship between timing of food insecurity and anthropometric outcomes may help to develop policies and health programme that address both of these issues.Trial registration numberNCT03187834.

scholarly journals Effects of Prenatal and Postnatal Maternal Multiple Micronutrient Supplementation on Child Growth and Morbidity in Tanzania: A Double-Blind, Randomized Controlled Trial

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 828-828
Author(s):  
Dongqing Wang ◽  
Uma Chandra Mouli Natchu ◽  
Anne Marie Darling ◽  
Ramadhani Noor ◽  
Ellen Hertzmark ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Child Growth ◽  
Mean Difference ◽  
Micronutrient Supplementation ◽  
Z Score ◽  
Double Blind ◽  
Randomized Controlled ◽  
Child Morbidity ◽  
Multiple Micronutrient

Abstract Objectives Maternal micronutrient status is critical for child growth and nutrition. It is unclear whether maternal multiple micronutrient supplementation (MMS) during pregnancy and lactation improves child growth and prevents child morbidity. The aim of this study was to determine the effects of prenatal and postnatal maternal MMS on child growth and morbidity in Tanzania. Methods In this double-blind, randomized controlled trial, 8,379 HIV-negative pregnant women were enrolled from Dar es Salaam, Tanzania, between 2001 and 2004. From pregnancy (12 to 27 weeks of gestation) through 6 weeks postpartum, participants were randomized to receive daily oral MMS or placebo. All women received daily iron and folic acid during pregnancy. From 6 weeks postpartum through 18 months postpartum, 3,100 women were re-randomized to MMS or placebo. Child growth measures, hemoglobin concentrations, and infectious morbidities were assessed longitudinally from birth to up to 18 months. Linear mixed-effects models were used to estimate the effects of prenatal and postnatal MMS on child growth z-scores and hemoglobin concentrations. Cox proportional hazards models were used to estimate the effects on undernutrition. Generalized estimating equations were used to estimate the effects on anemia and infectious morbidities. Results Prenatal MMS led to modest increases in weight-for-age z-score (mean difference: 0.050; 95% CI: 0.002, 0.099; p = 0.04) and length-for-age z-score (mean difference: 0.062; 95% CI: 0.013, 0.111; p = 0.01) during the first six months of life but not thereafter. Prenatal MMS did not have significant benefits for anemia, morbidity, or other child growth outcomes. Postnatal MMS did not have significant benefits for any child outcomes. Conclusions While maternal MMS is a proven strategy to prevent adverse birth outcomes, other approaches may also need to be considered to curb the high burdens of child morbidity and growth faltering. Funding Sources This work was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health.

scholarly journals Comparing Azithromycin to Amoxicillin in the Management of Uncomplicated Severe Acute Malnutrition in Burkina Faso: A Pilot Randomized Trial

2022 ◽  
Author(s):  
Kieran O’Brien ◽  
Ali Sié ◽  
Clarisse Dah ◽  
Millogo Ourohiré ◽  
Moussa Ouedraogo ◽  
...  
Keyword(s):  
Single Dose ◽  
Weight Gain ◽  
Burkina Faso ◽  
Severe Acute Malnutrition ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Acute Malnutrition ◽  
Average Weight ◽  
Promising Alternative

Azithromycin is a promising alternative to amoxicillin in the management of uncomplicated severe acute malnutrition (SAM) as it can be administered as a single dose and has efficacy against several pathogens causing infectious disease and mortality in children under 5. In this pilot trial, we aimed to establish the feasibility of a larger randomized controlled trial and provide preliminary evidence comparing the effect of azithromycin to amoxicillin on weight gain in children with uncomplicated SAM. We enrolled children 6–59 months old with uncomplicated SAM at six healthcare centers in Burkina Faso. Participants were randomized to a single dose of azithromycin or a 7-day course of amoxicillin and followed weekly until nutritional recovery and again at 8 weeks. Apart from antibiotics, participants received standard of care, which includes ready-to-use therapeutic food. Primary feasibility outcomes included enrollment potential, refusals, and loss to follow-up. The primary clinical outcome was weight gain (g/kg/day) over 8 weeks. Outcome assessors were masked. Between June and October 2020, 312 children were screened, 301 were enrolled with zero refusals, and 282 (93.6%) completed the 8-week visit. Average weight gain was 2.5 g/kg/day (standard deviation [SD] 2.0) in the azithromycin group and 2.6 (SD 1.7) in the amoxicillin group (mean difference −0.1, 95% CI −0.5 to 0.3, P = 0.63). Fewer adverse events were reported in the azithromycin group (risk ratio 0.50, 95% CI 0.31–0.82, P = 0.006). With strong enrollment and follow-up, a fully powered trial in this setting is feasible.

scholarly journals Association of Maternal Plasma Total Cysteine and Growth among Infants in Nepal: A Cohort Study

Nutrients ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 2849
Author(s):  
Nikhil Arora ◽  
Tor A. Strand ◽  
Ram K. Chandyo ◽  
Amany Elshorbagy ◽  
Laxman Shrestha ◽  
...  
Keyword(s):  
Birth Weight ◽  
Essential Amino Acid ◽  
Regression Models ◽  
Controlled Trial ◽  
Maternal Plasma ◽  
Child Growth ◽  
Negative Association ◽  
Linear Regression Models ◽  
Randomized Controlled ◽  
Z Scores

Cysteine is a semi-essential amino acid that has been positively associated with growth in children. However, transgenerational effects remain unclear. The aim of this analysis was to assess whether maternal plasma total cysteine (tCys) concentration is associated with various growth indicators in infants living in peri-urban settings in Bhaktapur, Nepal. We used data from the 561 mothers enrolled in an ongoing randomized controlled trial. We built linear regression models to evaluate the associations between maternal tCys and birth weight, length-for-age Z-scores (LAZ) and weight-for-length Z-scores (WLZ) at birth and six months of age. Maternal tCys was inversely associated with birth weight among boys after adjusting for confounders (p < 0.05). In addition, there was a negative association between maternal tCys and LAZ at birth (p < 0.01). No associations between maternal tCys and the other anthropometric indicators were found significant, although there was a tendency for maternal tCys to be associated positively with WLZ at birth among girls (p < 0.10). This is a first study evaluating transgenerational relation of tCys on growth in infants. Further, larger and more comprehensive studies are needed to determine if and how maternal tCys alters child growth.

Rationale, design, and challenges with implementing a clinical intervention to teach appropriate gestational weight gain (TAGG): Protocol of a Randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Awathif Mackeen ◽  
Danielle Downs ◽  
Vonda Hetherington ◽  
Shawnee Lutcher ◽  
Jacob Mowery ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Gestational Diabetes ◽  
Usual Care ◽  
Gestational Weight Gain ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Household Food Security ◽  
Gestational Weight ◽  
Randomized Controlled

BACKGROUND Excessive gestational weight gain (GWG) has public health implications including preterm birth, preeclampsia, gestational diabetes, and cesarean delivery. In an effort to mitigate adverse consequences of excessive GWG, this study tests a health intervention that includes enhancements to improve knowledge and awareness of appropriate GWG, and patient-centered nutritional counseling to promote appropriate GWG. OBJECTIVE The primary objective of the study was to increase the proportion of women who are managing their GWG as recommended by the IOM.4,5 METHODS This randomized controlled trial was conducted at Geisinger in Pennsylvania where excessive GWG is common among women with pre-conception obesity. Eligible, consenting participants with pre-pregnancy body mass index >30.0 kg/m2 were randomized (1:1) to: 1) Usual Care: usual written educational materials and counseling by an obstetric care provider or 2) Enhanced Care: Usual Care plus a) a personalized letter from a physician detailing appropriate GWG, b) exposure to individualized GWG chart in the electronic health record via the patient portal, and c) a consult with a Registered Dietitian Nutritionist and follow-up via tele-health counseling (10-20 mins/1-2 weeks) for the duration of the pregnancy. RESULTS The primary outcome was the proportion of women that gain less than 20 pounds over the course of the pregnancy. Secondary outcomes include knowledge, expectations, and attitude about pregnancy weight gain; increased self-efficacy for ability to eat healthy and being physically active to manage weight; and eating behavior. Potential moderators that will be explored include sleep, perceived stress, perceived involvement in care, and household food security. Data collection has been completed as of November 2019. CONCLUSIONS As GWG care was initiated for mothers with pre-pregnancy BMI >30 kg/m2 within the first and second trimesters, the intervention may have the additional benefit of reducing other adverse pregnancy outcomes including the incidence of gestational diabetes due to healthier rates of GWG. In addition to assessing appropriate GWG, this project will assess eating habits, physical activity, GWG attitudes, sleep quality, and psychological measures, all of which are associated with GWG. Exploratory mediators including perceived stress and food insecurity will also be evaluated. CLINICALTRIAL ClinicalTrials.gov NCT02963428

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