Journal Article > ResearchFull Text
PLOS Med. 2021 August 10; Volume 18 (Issue 8); e1003720.; DOI:10.1371/journal.pmed.1003720
Isanaka S, Garba S, Plikaytis BD, McNeal MM, Guindo O, et al.
PLOS Med. 2021 August 10; Volume 18 (Issue 8); e1003720.; DOI:10.1371/journal.pmed.1003720
BACKGROUND
Nutritional status may play a role in infant immune development. To identify potential boosters of immunogenicity in low-income countries where oral vaccine efficacy is low, we tested the effect of prenatal nutritional supplementation on immune response to 3 doses of a live oral rotavirus vaccine.
METHODS AND FINDINGS
We nested a cluster randomized trial within a double-blind, placebo-controlled randomized efficacy trial to assess the effect of 3 prenatal nutritional supplements (lipid-based nutrient supplement [LNS], multiple micronutrient supplement [MMS], or iron–folic acid [IFA]) on infant immune response (n = 53 villages and 1,525 infants with valid serology results: 794 in the vaccine group and 731 in the placebo group). From September 2015 to February 2017, participating women received prenatal nutrient supplement during pregnancy. Eligible infants were then randomized to receive 3 doses of an oral rotavirus vaccine or placebo at 6–8 weeks of age (mean age: 6.3 weeks, 50% female). Infant sera (pre-Dose 1 and 28 days post-Dose 3) were analyzed for anti-rotavirus immunoglobulin A (IgA) using enzyme-linked immunosorbent assay (ELISA). The primary immunogenicity end point, seroconversion defined as ≥3-fold increase in IgA, was compared in vaccinated infants among the 3 supplement groups and between vaccine/placebo groups using mixed model analysis of variance procedures. Seroconversion did not differ by supplementation group (41.1% (94/229) with LNS vs. 39.1% (102/261) with multiple micronutrients (MMN) vs. 38.8% (118/304) with IFA, p = 0.91). Overall, 39.6% (n = 314/794) of infants who received vaccine seroconverted, compared to 29.0% (n = 212/731) of infants who received placebo (relative risk [RR]: 1.36; 95% confidence interval [CI]: 1.18, 1.57, p < 0.001). This study was conducted in a high rotavirus transmission setting. Study limitations include the absence of an immune correlate of protection for rotavirus vaccines, with the implications of using serum anti-rotavirus IgA for the assessment of immunogenicity and efficacy in low-income countries unclear.
CONCLUSIONS
This study showed no effect of the type of prenatal nutrient supplementation on immune response in this setting. Immune response varied depending on previous exposure to rotavirus, suggesting that alternative delivery modalities and schedules may be considered to improve vaccine performance in high transmission settings.
Nutritional status may play a role in infant immune development. To identify potential boosters of immunogenicity in low-income countries where oral vaccine efficacy is low, we tested the effect of prenatal nutritional supplementation on immune response to 3 doses of a live oral rotavirus vaccine.
METHODS AND FINDINGS
We nested a cluster randomized trial within a double-blind, placebo-controlled randomized efficacy trial to assess the effect of 3 prenatal nutritional supplements (lipid-based nutrient supplement [LNS], multiple micronutrient supplement [MMS], or iron–folic acid [IFA]) on infant immune response (n = 53 villages and 1,525 infants with valid serology results: 794 in the vaccine group and 731 in the placebo group). From September 2015 to February 2017, participating women received prenatal nutrient supplement during pregnancy. Eligible infants were then randomized to receive 3 doses of an oral rotavirus vaccine or placebo at 6–8 weeks of age (mean age: 6.3 weeks, 50% female). Infant sera (pre-Dose 1 and 28 days post-Dose 3) were analyzed for anti-rotavirus immunoglobulin A (IgA) using enzyme-linked immunosorbent assay (ELISA). The primary immunogenicity end point, seroconversion defined as ≥3-fold increase in IgA, was compared in vaccinated infants among the 3 supplement groups and between vaccine/placebo groups using mixed model analysis of variance procedures. Seroconversion did not differ by supplementation group (41.1% (94/229) with LNS vs. 39.1% (102/261) with multiple micronutrients (MMN) vs. 38.8% (118/304) with IFA, p = 0.91). Overall, 39.6% (n = 314/794) of infants who received vaccine seroconverted, compared to 29.0% (n = 212/731) of infants who received placebo (relative risk [RR]: 1.36; 95% confidence interval [CI]: 1.18, 1.57, p < 0.001). This study was conducted in a high rotavirus transmission setting. Study limitations include the absence of an immune correlate of protection for rotavirus vaccines, with the implications of using serum anti-rotavirus IgA for the assessment of immunogenicity and efficacy in low-income countries unclear.
CONCLUSIONS
This study showed no effect of the type of prenatal nutrient supplementation on immune response in this setting. Immune response varied depending on previous exposure to rotavirus, suggesting that alternative delivery modalities and schedules may be considered to improve vaccine performance in high transmission settings.
Conference Material > Poster
Isanaka S, Garba S, Cabrera ME, Rocaspana M
MSF Scientific Days International 2021: Research. 2021 May 18; Volume 7 (Issue 1); 47.
Journal Article > ResearchFull Text
BMC Nutr. 2021 August 12; Volume 7(1) (Issue 47); DOI:10.1186/s40795-021-00448-w
Garba S, Salou H, Nackers F, Ayouba A, Guindo O, et al.
BMC Nutr. 2021 August 12; Volume 7(1) (Issue 47); DOI:10.1186/s40795-021-00448-w
BACKGROUND
The World Health Organization recommends the use of a weight-for-height Z-score (WHZ) and/or mid-upper arm circumference (MUAC) as anthropometric criteria for the admission and discharge of young children for the community-based management of severe acute malnutrition. However, using MUAC as a single anthropometric criterion for admission and discharge in therapeutic nutritional programs may offer operational advantages to simplify admission processes at therapeutic nutritional centers and improve program coverage.
METHOD
This pragmatic, non-randomized, intervention study compared a standard outpatient nutritional program (n = 824) for the treatment of uncomplicated severe acute malnutrition using WHZ < - 3 and/or MUAC< 115 mm and/or bipedal edema for admission and discharge to a program (n = 1019) using MUAC as the sole anthropometric criterion for admission (MUAC< 120 mm) and discharge (MUAC ≥125 mm at two consecutive visits) in the Tahoua Region of Niger.
RESULTS
Compared to the standard program, the MUAC-only program discharged more children as recovered (70.1% vs. 51.6%; aOR 2.31, 95%CI 1.79-2.98) and fewer children as non-respondent or defaulters, based on respective program definitions. The risk of non-response was high in both programs. Three months post-discharge, children who were discharged after recovery in the MUAC-only program had lower WHZ and MUAC measures. Sixty-three children ineligible for the MUAC-only program but eligible for a standard program (MUAC ≥120 mm and WHZ < -3) were followed for twelve weeks and the anthropometric status of 69.8% of these children did not deteriorate (i.e. MUAC ≥120 mm) despite not immediately receiving treatment in the MUAC-only program.
CONCLUSION
The results from this study share the first operational experience of using MUAC as sole anthropometric criterion for admission and discharge in Niger and overall support the consideration for MUAC-only programming: the MUAC-only model of care was associated with a higher recovery and a lower defaulter rate than the standard program with very few children found to be excluded from treatment with an admission criterion of MUAC < 120 mm. Further consideration of the appropriate MUAC-based discharge criterion as it relates to an increased risk of non-response and adverse post-discharge outcomes would be prudent.
The World Health Organization recommends the use of a weight-for-height Z-score (WHZ) and/or mid-upper arm circumference (MUAC) as anthropometric criteria for the admission and discharge of young children for the community-based management of severe acute malnutrition. However, using MUAC as a single anthropometric criterion for admission and discharge in therapeutic nutritional programs may offer operational advantages to simplify admission processes at therapeutic nutritional centers and improve program coverage.
METHOD
This pragmatic, non-randomized, intervention study compared a standard outpatient nutritional program (n = 824) for the treatment of uncomplicated severe acute malnutrition using WHZ < - 3 and/or MUAC< 115 mm and/or bipedal edema for admission and discharge to a program (n = 1019) using MUAC as the sole anthropometric criterion for admission (MUAC< 120 mm) and discharge (MUAC ≥125 mm at two consecutive visits) in the Tahoua Region of Niger.
RESULTS
Compared to the standard program, the MUAC-only program discharged more children as recovered (70.1% vs. 51.6%; aOR 2.31, 95%CI 1.79-2.98) and fewer children as non-respondent or defaulters, based on respective program definitions. The risk of non-response was high in both programs. Three months post-discharge, children who were discharged after recovery in the MUAC-only program had lower WHZ and MUAC measures. Sixty-three children ineligible for the MUAC-only program but eligible for a standard program (MUAC ≥120 mm and WHZ < -3) were followed for twelve weeks and the anthropometric status of 69.8% of these children did not deteriorate (i.e. MUAC ≥120 mm) despite not immediately receiving treatment in the MUAC-only program.
CONCLUSION
The results from this study share the first operational experience of using MUAC as sole anthropometric criterion for admission and discharge in Niger and overall support the consideration for MUAC-only programming: the MUAC-only model of care was associated with a higher recovery and a lower defaulter rate than the standard program with very few children found to be excluded from treatment with an admission criterion of MUAC < 120 mm. Further consideration of the appropriate MUAC-based discharge criterion as it relates to an increased risk of non-response and adverse post-discharge outcomes would be prudent.
Journal Article > ResearchFull Text
Int J Infect Dis. 2022 March 25; Volume S1201-9712 (Issue 22); 00184-9.; DOI:10.1016/j.ijid.2022.03.047
Andersen CT, Langendorf C, Garba S, Sayinzoga-Makombe N, Mambula C, et al.
Int J Infect Dis. 2022 March 25; Volume S1201-9712 (Issue 22); 00184-9.; DOI:10.1016/j.ijid.2022.03.047
OBJECTIVE
To estimate the prevalence and antibiotic resistance profile of community- and hospital-acquired bacteremia among hospitalized children with severe acute malnutrition in Niger.
METHODS
A descriptive, longitudinal study was conducted in an intensive nutritional rehabilitation center in Madarounfa, Niger. Children aged 6 to 59 months admitted for inpatient treatment of complicated severe acute malnutrition (n=2187) had blood specimens drawn at admission to assess prevalence of community-acquired bacteremia. Subsequent specimens were drawn per physician discretion to assess incidence of hospital-acquired bacteremia. Antibiotic susceptibility testing was performed on positive blood cultures.
RESULTS
The prevalence of community-acquired bacteremia at admission was at least 9.1% (95% CI: 8.1, 10.4%), with non-typhoid Salmonella identified in over half (57.8%) of cases. The cumulative incidence of hospital-acquired bacteremia was estimated at 1.2% (95% CI: 0.8, 1.7%), among which the most common organisms were Klebsiella pneumoniae (19.4%), Acinetobacter baumannii (16.1%), Enterococcus faecalis (12.9%), and Escherichia coli (12.9%). Among community-acquired bacteremia, 58% were resistant to amoxicillin-clavulanate; 100% of hospital-acquired bacteremia were resistant to amoxicillin and amoxicillin-clavulanate. Mortality risk was elevated among children with hospital-acquired bacteremia (RR=9.32) and community-acquired bacteremia (RR=2.67).
CONCLUSION
Bacteremia was a significant contributor to mortality. Antibiotic resistance poses a challenge to effective clinical management of SAM.
To estimate the prevalence and antibiotic resistance profile of community- and hospital-acquired bacteremia among hospitalized children with severe acute malnutrition in Niger.
METHODS
A descriptive, longitudinal study was conducted in an intensive nutritional rehabilitation center in Madarounfa, Niger. Children aged 6 to 59 months admitted for inpatient treatment of complicated severe acute malnutrition (n=2187) had blood specimens drawn at admission to assess prevalence of community-acquired bacteremia. Subsequent specimens were drawn per physician discretion to assess incidence of hospital-acquired bacteremia. Antibiotic susceptibility testing was performed on positive blood cultures.
RESULTS
The prevalence of community-acquired bacteremia at admission was at least 9.1% (95% CI: 8.1, 10.4%), with non-typhoid Salmonella identified in over half (57.8%) of cases. The cumulative incidence of hospital-acquired bacteremia was estimated at 1.2% (95% CI: 0.8, 1.7%), among which the most common organisms were Klebsiella pneumoniae (19.4%), Acinetobacter baumannii (16.1%), Enterococcus faecalis (12.9%), and Escherichia coli (12.9%). Among community-acquired bacteremia, 58% were resistant to amoxicillin-clavulanate; 100% of hospital-acquired bacteremia were resistant to amoxicillin and amoxicillin-clavulanate. Mortality risk was elevated among children with hospital-acquired bacteremia (RR=9.32) and community-acquired bacteremia (RR=2.67).
CONCLUSION
Bacteremia was a significant contributor to mortality. Antibiotic resistance poses a challenge to effective clinical management of SAM.
Journal Article > ResearchFull Text
Matern Child Nutr. 2022 July 21; Online ahead of print; e13400.; DOI:10.1111/mcn.13400
Bliznashka L, Grantz KH, Botton J, Berthé F, Garba S, et al.
Matern Child Nutr. 2022 July 21; Online ahead of print; e13400.; DOI:10.1111/mcn.13400
This study aimed to quantify the burden of relapse following successful treatment for uncomplicated severe acute malnutrition (SAM) and to identify associated risk factors in rural Niger. We used data from 1490 children aged 6-59 months discharged as recovered from an outpatient nutritional programme for SAM and followed for up to 12 weeks after admission. Post-discharge SAM relapse was defined as weight-for-height Z-score <-3, mid-upper arm circumference (MUAC) <115 mm or bipedal oedema after having been discharged as recovered. Post-discharge hospitalisation was defined as admission to inpatient SAM treatment or hospitalisation for any cause after having been discharged as recovered. We used multivariate log-binomial models to identify independent risk factors. After programmatic discharge, 114 (8%) children relapsed to SAM and 89 (6%) were hospitalised. Factors associated with SAM relapse were discharge during the lean season (relative risk [RR] = 1.80 [95% confidence interval [CI] = 1.22-2.67]) and larger household size (RR = 1.56 [95% CI = 1.01-2.41]), whereas older child age (RR = 0.94 [95% CI = 0.88-1.00]), higher child MUAC at discharge (RR = 0.93 [95% CI = 0.87-1.00]) and maternal literacy (RR = 0.54 [95% CI = 0.29-0.98]) were protective factors. Discharge during the lean season (RR = 2.27 [95% CI = 1.46-3.51]) was independently associated with post-discharge hospitalisation. Future nutritional programmes in the context of Niger may consider modification of anthropometric discharge criteria or the provision of additional home support or follow-up during the lean season as potential interventions to prevent relapse. More research including post-discharge follow-up is needed to better understand the sustainability of treatment outcomes after discharge and the type of intervention that may best sustain recovery over time.
Clinical Trial Registration: ClinicalTrials.gov number, NCT01613547.
Clinical Trial Registration: ClinicalTrials.gov number, NCT01613547.
Journal Article > ResearchFull Text
PLOS Med. 2021 July 2; Volume 18 (Issue 7); e1003655.; DOI:10.1371/journal.pmed.1003655
Isanaka S, Langendorf C, McNeal MM, Meyer N, Plikaytis BD, et al.
PLOS Med. 2021 July 2; Volume 18 (Issue 7); e1003655.; DOI:10.1371/journal.pmed.1003655
BACKGROUND
Rotavirus vaccination is recommended in all countries to reduce the burden of diarrhea-related morbidity and mortality in children. In resource-limited settings, rotavirus vaccination in the national immunization program has important cost implications, and evidence for protection beyond the first year of life and against the evolving variety of rotavirus strains is important. We assessed the extended and strain-specific vaccine efficacy of a heat-stable, affordable oral rotavirus vaccine (Rotasiil, Serum Institute of India, Pune, India) against severe rotavirus gastroenteritis (SRVGE) among healthy infants in Niger.
METHODS AND FINDINGS
From August 2014 to November 2015, infants were randomized in a 1:1 ratio to receive 3 doses of Rotasiil or placebo at approximately 6, 10, and 14 weeks of age. Episodes of gastroenteritis were assessed through active and passive surveillance and graded using the Vesikari score. The primary endpoint was vaccine efficacy of 3 doses of vaccine versus placebo against a first episode of laboratory-confirmed SRVGE (Vesikari score ≥ 11) from 28 days after dose 3, as previously reported. At the time of the primary analysis, median age was 9.8 months. In the present paper, analyses of extended efficacy were undertaken for 3 periods (28 days after dose 3 to 1 year of age, 1 to 2 years of age, and the combined period 28 days after dose 3 to 2 years of age) and by individual rotavirus G type. Among the 3,508 infants included in the per-protocol efficacy analysis (mean age at first dose 6.5 weeks; 49% male), the vaccine provided significant protection against SRVGE through the first year of life (3.96 and 9.98 cases per 100 person-years for vaccine and placebo, respectively; vaccine efficacy 60.3%, 95% CI 43.6% to 72.1%) and over the entire efficacy follow-up period up to 2 years of age (2.13 and 4.69 cases per 100 person-years for vaccine and placebo, respectively; vaccine efficacy 54.7%, 95% CI 38.1% to 66.8%), but the difference was not statistically significant in the second year of life. Up to 2 years of age, rotavirus vaccination prevented 2.56 episodes of SRVGE per 100 child-years. Estimates of efficacy against SRVGE by individual rotavirus genotype were consistent with the overall protective efficacy. Study limitations include limited generalizability to settings with administration of oral polio virus due to low concomitant administration, limited power to assess vaccine efficacy in the second year of life owing to a low number of events among older children, potential bias due to censoring of placebo children at the time of study vaccine receipt, and suboptimal adapted severity scoring based on the Vesikari score, which was designed for use in settings with high parental literacy.
CONCLUSIONS
Rotasiil provided protection against SRVGE in infants through an extended follow-up period of approximately 2 years. Protection was significant in the first year of life, when the disease burden and risk of death are highest, and against a changing pattern of rotavirus strains during the 2-year efficacy period. Rotavirus vaccines that are safe, effective, and protective against multiple strains represent the best hope for preventing the severe consequences of rotavirus infection, especially in resource-limited settings, where access to care may be limited. Studies such as this provide valuable information for the planning of national immunization programs and future vaccine development.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02145000.
Rotavirus vaccination is recommended in all countries to reduce the burden of diarrhea-related morbidity and mortality in children. In resource-limited settings, rotavirus vaccination in the national immunization program has important cost implications, and evidence for protection beyond the first year of life and against the evolving variety of rotavirus strains is important. We assessed the extended and strain-specific vaccine efficacy of a heat-stable, affordable oral rotavirus vaccine (Rotasiil, Serum Institute of India, Pune, India) against severe rotavirus gastroenteritis (SRVGE) among healthy infants in Niger.
METHODS AND FINDINGS
From August 2014 to November 2015, infants were randomized in a 1:1 ratio to receive 3 doses of Rotasiil or placebo at approximately 6, 10, and 14 weeks of age. Episodes of gastroenteritis were assessed through active and passive surveillance and graded using the Vesikari score. The primary endpoint was vaccine efficacy of 3 doses of vaccine versus placebo against a first episode of laboratory-confirmed SRVGE (Vesikari score ≥ 11) from 28 days after dose 3, as previously reported. At the time of the primary analysis, median age was 9.8 months. In the present paper, analyses of extended efficacy were undertaken for 3 periods (28 days after dose 3 to 1 year of age, 1 to 2 years of age, and the combined period 28 days after dose 3 to 2 years of age) and by individual rotavirus G type. Among the 3,508 infants included in the per-protocol efficacy analysis (mean age at first dose 6.5 weeks; 49% male), the vaccine provided significant protection against SRVGE through the first year of life (3.96 and 9.98 cases per 100 person-years for vaccine and placebo, respectively; vaccine efficacy 60.3%, 95% CI 43.6% to 72.1%) and over the entire efficacy follow-up period up to 2 years of age (2.13 and 4.69 cases per 100 person-years for vaccine and placebo, respectively; vaccine efficacy 54.7%, 95% CI 38.1% to 66.8%), but the difference was not statistically significant in the second year of life. Up to 2 years of age, rotavirus vaccination prevented 2.56 episodes of SRVGE per 100 child-years. Estimates of efficacy against SRVGE by individual rotavirus genotype were consistent with the overall protective efficacy. Study limitations include limited generalizability to settings with administration of oral polio virus due to low concomitant administration, limited power to assess vaccine efficacy in the second year of life owing to a low number of events among older children, potential bias due to censoring of placebo children at the time of study vaccine receipt, and suboptimal adapted severity scoring based on the Vesikari score, which was designed for use in settings with high parental literacy.
CONCLUSIONS
Rotasiil provided protection against SRVGE in infants through an extended follow-up period of approximately 2 years. Protection was significant in the first year of life, when the disease burden and risk of death are highest, and against a changing pattern of rotavirus strains during the 2-year efficacy period. Rotavirus vaccines that are safe, effective, and protective against multiple strains represent the best hope for preventing the severe consequences of rotavirus infection, especially in resource-limited settings, where access to care may be limited. Studies such as this provide valuable information for the planning of national immunization programs and future vaccine development.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02145000.
Journal Article > ResearchFull Text
Vaccine. 2018 May 8; Volume 36 (Issue 25); 3674-3680.; DOI:10.1016/j.vaccine.2018.05.023
Coldiron ME, Guindo O, Makarimi R, Soumana I, Matar Seck A, et al.
Vaccine. 2018 May 8; Volume 36 (Issue 25); 3674-3680.; DOI:10.1016/j.vaccine.2018.05.023
BACKGROUND
Rotavirus remains a major cause of diarrhea among children under 5 years of age. The efficacy of RotaSIIL, a pentavalent rotavirus vaccine, was shown in an event-driven trial in Niger. We describe the two-year safety follow-up of this trial.
METHODS
Follow-up of safety outcomes began upon administration of the first dose of RotaSIIL or placebo. Adverse events were followed until 28 days after the third dose, and serious adverse events were followed until 2 years of age. Suspected cases of intussusception were evaluated at first point of contact and then referred to hospital for surgical evaluation. Causes of death were obtained by chart review and verbal autopsy. Passive surveillance was carried out in health centers. Community health workers carried out active surveillance in villages. Between-group differences were evaluated using the chi-squared test and Fisher's exact test.
RESULTS
A total of 4092 children were randomized, and 4086 received at least one dose of RotaSIIL or placebo, constituting the intention-to-treat population, who accrued a total of 7385 child-years of follow-up time. At two years of follow-up, 58 (2.8%) participants who received RotaSIIL and 49 (2.4%) participants who received placebo had died (p = 0.38). Most deaths were due to infectious causes common to the study area. One participant had confirmed intussusception, 542 days after receiving the third dose of RotaSIIL. A total of 395 (19.3%) participants receiving RotaSIIL and 419 (20.5%) participants receiving placebo experienced any serious adverse event (p = 0.36). Most serious adverse events were hospitalizations due to infection (malaria, lower respiratory tract infection and gastroenteritis) or marasmus. Overall, 1474 (72.1%) participants receiving RotaSIIL and 1456 (71.1%) participants receiving placebo had at least one adverse event (p = 0.49) in the follow-up period.
CONCLUSIONS
At two years of follow-up, RotaSIIL was found to be safe.
Rotavirus remains a major cause of diarrhea among children under 5 years of age. The efficacy of RotaSIIL, a pentavalent rotavirus vaccine, was shown in an event-driven trial in Niger. We describe the two-year safety follow-up of this trial.
METHODS
Follow-up of safety outcomes began upon administration of the first dose of RotaSIIL or placebo. Adverse events were followed until 28 days after the third dose, and serious adverse events were followed until 2 years of age. Suspected cases of intussusception were evaluated at first point of contact and then referred to hospital for surgical evaluation. Causes of death were obtained by chart review and verbal autopsy. Passive surveillance was carried out in health centers. Community health workers carried out active surveillance in villages. Between-group differences were evaluated using the chi-squared test and Fisher's exact test.
RESULTS
A total of 4092 children were randomized, and 4086 received at least one dose of RotaSIIL or placebo, constituting the intention-to-treat population, who accrued a total of 7385 child-years of follow-up time. At two years of follow-up, 58 (2.8%) participants who received RotaSIIL and 49 (2.4%) participants who received placebo had died (p = 0.38). Most deaths were due to infectious causes common to the study area. One participant had confirmed intussusception, 542 days after receiving the third dose of RotaSIIL. A total of 395 (19.3%) participants receiving RotaSIIL and 419 (20.5%) participants receiving placebo experienced any serious adverse event (p = 0.36). Most serious adverse events were hospitalizations due to infection (malaria, lower respiratory tract infection and gastroenteritis) or marasmus. Overall, 1474 (72.1%) participants receiving RotaSIIL and 1456 (71.1%) participants receiving placebo had at least one adverse event (p = 0.49) in the follow-up period.
CONCLUSIONS
At two years of follow-up, RotaSIIL was found to be safe.
Journal Article > ResearchFull Text
BMC Public Health. 2021 September 21; Volume 21 (Issue 1); 1713.; DOI:10.1186/s12889-021-11689-6
Kohlmann K, Sudfeld CR, Garba S, Guindo O, Grais RF, et al.
BMC Public Health. 2021 September 21; Volume 21 (Issue 1); 1713.; DOI:10.1186/s12889-021-11689-6
BACKGROUND
Wasting and stunting, physical growth manifestations of child undernutrition, have historically been considered separately with distinct interventions at the program, policy, and financing levels despite similar risk factors, overlapping burdens and multiplicative risk of death when the conditions are concurrent. The aim of this study was to elucidate shared risk factors and the temporal relationship between wasting and stunting among children under 2 years of age in rural Niger.
METHODS
From August 2014 to December 2019, anthropometric data were collected every 4 weeks from 6 to 8 weeks to 24 months of age for 6567 children comprising 139,529 visits in Madarounfa, Niger. Children were defined as wasted if they had a weight-for-length Z-score < − 2 and stunted if they had a length-for-age Z-score < − 2 using the 2006 World Health Organization child growth standards. Parental, child, and socioeconomic risk factors for wasting and stunting at 6 and 24 months of age and the relationship between episodes of wasting, stunting and concurrent wasting-stunting were assessed using general estimating equations.
RESULTS
Half of children (50%) were female, and 8.3% were born low birthweight (< 2500 g). Overall, at 24 months of age, 14% of children were wasted, 80% were stunted and 12% were concurrently wasted-stunted. We found that maternal short stature, male sex, and low birthweight were risk factors for wasting and stunting at 6 and 24 months, whereas higher maternal body mass index and household wealth were protective factors. Wasting at 6 and 24 months was predicted by a prior episodes of wasting, stunting, and concurrent wasting-stunting. Stunting at 6 and 24 months was similarly predicted by prior episodes of stunting and concurrent wasting-stunting at any prior age but only by prior episodes of wasting after 6 months of age.
CONCLUSIONS
These data support a complex and dynamic bi-directional relationship between wasting and stunting in young children in rural Niger and an important burden of concurrent wasting-stunting in this setting. Further research to better understand the inter-relationships and mechanisms between these two conditions is needed in order to develop and target interventions to promote child growth.
Wasting and stunting, physical growth manifestations of child undernutrition, have historically been considered separately with distinct interventions at the program, policy, and financing levels despite similar risk factors, overlapping burdens and multiplicative risk of death when the conditions are concurrent. The aim of this study was to elucidate shared risk factors and the temporal relationship between wasting and stunting among children under 2 years of age in rural Niger.
METHODS
From August 2014 to December 2019, anthropometric data were collected every 4 weeks from 6 to 8 weeks to 24 months of age for 6567 children comprising 139,529 visits in Madarounfa, Niger. Children were defined as wasted if they had a weight-for-length Z-score < − 2 and stunted if they had a length-for-age Z-score < − 2 using the 2006 World Health Organization child growth standards. Parental, child, and socioeconomic risk factors for wasting and stunting at 6 and 24 months of age and the relationship between episodes of wasting, stunting and concurrent wasting-stunting were assessed using general estimating equations.
RESULTS
Half of children (50%) were female, and 8.3% were born low birthweight (< 2500 g). Overall, at 24 months of age, 14% of children were wasted, 80% were stunted and 12% were concurrently wasted-stunted. We found that maternal short stature, male sex, and low birthweight were risk factors for wasting and stunting at 6 and 24 months, whereas higher maternal body mass index and household wealth were protective factors. Wasting at 6 and 24 months was predicted by a prior episodes of wasting, stunting, and concurrent wasting-stunting. Stunting at 6 and 24 months was similarly predicted by prior episodes of stunting and concurrent wasting-stunting at any prior age but only by prior episodes of wasting after 6 months of age.
CONCLUSIONS
These data support a complex and dynamic bi-directional relationship between wasting and stunting in young children in rural Niger and an important burden of concurrent wasting-stunting in this setting. Further research to better understand the inter-relationships and mechanisms between these two conditions is needed in order to develop and target interventions to promote child growth.
Journal Article > ResearchFull Text
Am J Clin Nutr. 2021 December 6; Volume 115 (Issue 3); 738-748.; DOI:10.1093/ajcn/nqab404
Bliznashka L, Sudfeld CR, Garba S, Guindo O, Soumana I, et al.
Am J Clin Nutr. 2021 December 6; Volume 115 (Issue 3); 738-748.; DOI:10.1093/ajcn/nqab404
BACKGROUND
Prenatal multiple micronutrient supplementation (MMS) and lipid-based nutrient supplementation (LNS) can improve birth outcomes relative to iron-folic acid supplementation (IFA); however, effects on child postnatal growth remain unclear.
OBJECTIVE
To compare the effect of prenatal MMS, medium-quantity LNS (MQ-LNS), and IFA on child growth up to 2 years of age.
DESIGN
We conducted a cluster-randomized controlled trial of prenatal nutritional supplementation in Madarounfa, Niger. Villages were randomly assigned for pregnant women to receive IFA (17 villages, 1105 women), MMS (18 villages, 1083 women) or MQ-LNS (18 villages, 1144 women). Pregnant women received nutritional supplements weekly until delivery, and children were followed up monthly from 6-8 weeks to 24 months of age. We assessed the effect of prenatal MMS and MQ-LNS compared to IFA and the effect of prenatal MMS compared to MQ-LNS on child length-for-age Z-scores (LAZ), weight-for-age Z-scores (WAZ), and weight-for-length Z-scores (WLZ) at 24 months of age using generalized linear models. In secondary analyses, we used mixed effects models to assess the trajectory of anthropometric Z-scores longitudinally from 6-8 weeks to 24 months.
RESULTS
Compared to IFA, MMS and MQ-LNS had no effect on child LAZ, WAZ, or WLZ at 24 months of age (P-values >0.05). Children in the MQ-LNS arm had significantly higher MUAC at 24 months than children in the MMS arm: mean difference 0.50 cm (95% CI 0.10, 0.91). WAZ and WLZ trajectories were more negative in the MQ-LNS arm compared to IFA and MMS, with lower Z-scores from 14 to 20 months of age. However, WAZ and WLZ trajectories converged after 20 months of age, and there were no differences by 24 months of age.
CONCLUSIONS
Prenatal MMS and MQ-LNS had limited effect on anthropometric measures of child growth up to 24 months of age as compared to IFA in rural Niger.
Prenatal multiple micronutrient supplementation (MMS) and lipid-based nutrient supplementation (LNS) can improve birth outcomes relative to iron-folic acid supplementation (IFA); however, effects on child postnatal growth remain unclear.
OBJECTIVE
To compare the effect of prenatal MMS, medium-quantity LNS (MQ-LNS), and IFA on child growth up to 2 years of age.
DESIGN
We conducted a cluster-randomized controlled trial of prenatal nutritional supplementation in Madarounfa, Niger. Villages were randomly assigned for pregnant women to receive IFA (17 villages, 1105 women), MMS (18 villages, 1083 women) or MQ-LNS (18 villages, 1144 women). Pregnant women received nutritional supplements weekly until delivery, and children were followed up monthly from 6-8 weeks to 24 months of age. We assessed the effect of prenatal MMS and MQ-LNS compared to IFA and the effect of prenatal MMS compared to MQ-LNS on child length-for-age Z-scores (LAZ), weight-for-age Z-scores (WAZ), and weight-for-length Z-scores (WLZ) at 24 months of age using generalized linear models. In secondary analyses, we used mixed effects models to assess the trajectory of anthropometric Z-scores longitudinally from 6-8 weeks to 24 months.
RESULTS
Compared to IFA, MMS and MQ-LNS had no effect on child LAZ, WAZ, or WLZ at 24 months of age (P-values >0.05). Children in the MQ-LNS arm had significantly higher MUAC at 24 months than children in the MMS arm: mean difference 0.50 cm (95% CI 0.10, 0.91). WAZ and WLZ trajectories were more negative in the MQ-LNS arm compared to IFA and MMS, with lower Z-scores from 14 to 20 months of age. However, WAZ and WLZ trajectories converged after 20 months of age, and there were no differences by 24 months of age.
CONCLUSIONS
Prenatal MMS and MQ-LNS had limited effect on anthropometric measures of child growth up to 24 months of age as compared to IFA in rural Niger.