Journal Article > ResearchFull Text
Appetite. 2016 January 2; Volume 99; DOI:10.1016/j.appet.2015.12.030
Iuel-Brockdorf AS, Draebel TA, Ritz C, Fabiansen C, Cichon B, et al.
Appetite. 2016 January 2; Volume 99; DOI:10.1016/j.appet.2015.12.030
The objective of this study was to evaluate, within the context of a randomized controlled trial of product effectiveness, the acceptability of new formulations of six corn-soy blended flours (CSB) and six lipid-based nutrient supplements (LNS) with different quantities of milk and qualities of soy for the treatment of children with moderate acute malnutrition (MAM). Our study included 1546 children aged 6-23 months and involved questionnaires after one month of supplementation home visits and interviews with a sub-sample of 20 trial participants and their caretakers, and nine focus group discussion. All 12 products were well accepted in terms of organoleptic qualities and received good ratings. However, LNS were more appreciated by caretakers and children. Additionally, an effect of soy isolate was detected on child appreciation where products with high milk content also received better ratings. CSB were not consumed as readily; 33.9% (n = 257) of children receiving CSB were reported to have leftovers compared to 17.3% (n = 134) of children receiving LNS (p=<0.001). Both CSB and LNS were referred to as foods with medicinal properties and perceived as beneficial to child health. They were both reported to have high priority in the daily feeding of the child. In conclusion, there were minimal differences in acceptability of the various CSB and LNS formulations, although CSB were less readily consumed and required smaller meal volumes. Since all products were well-accepted, decisions regarding whether the more expensive products should be used for the treatment of MAM will need to be based on their effect on child nutrition, growth and health. Future supplementary feeding programs in similar contexts could furthermore consider introducing supplementary foods as a medical treatment, as this may increase adherence and decrease sharing.
Journal Article > ReviewFull Text
Lancet Global Health. 2021 May 1; Volume 9 (Issue 5); e681-e690.; DOI:10.1016/S2214-109X(20)30539-8
Park JS, Grais RF, Taljaard M, Nakimuli-Mpungu E, Jehan F, et al.
Lancet Global Health. 2021 May 1; Volume 9 (Issue 5); e681-e690.; DOI:10.1016/S2214-109X(20)30539-8
This paper shows the scale of global health research and the context in which we frame the subsequent papers in the Series. In this Series paper, we provide a historical perspective on clinical trial research by revisiting the 1948 streptomycin trial for pulmonary tuberculosis, which was the first documented randomised clinical trial in the English language, and we discuss its close connection with global health. We describe the current state of clinical trial research globally by providing an overview of clinical trials that have been registered in the WHO International Clinical Trial Registry since 2010. We discuss challenges with current trial planning and designs that are often used in clinical trial research undertaken in low-income and middle-income countries, as an overview of the global health trials landscape. Finally, we discuss the importance of collaborative work in global health research towards generating sustainable and culturally appropriate research environments.
Journal Article > ResearchFull Text
BMJ Glob Health. 2020 November 1; Volume 5 (Issue Suppl 1); e002060.; DOI:10.1136/bmjgh-2019-002060
Aboubakar S, Evers ES, Kobeissi L, Francis L, Najjemba R, et al.
BMJ Glob Health. 2020 November 1; Volume 5 (Issue Suppl 1); e002060.; DOI:10.1136/bmjgh-2019-002060
BACKGROUND
Significant global gains in sexual, reproductive, maternal, newborn, child and adolescent health and nutrition (SRMNCAH&N) will be difficult unless conflict settings are adequately addressed. We aimed to determine the amount, scope and quality of publicly available guidance documents, to characterise the process by which agencies develop their guidance and to identify gaps in guidance on SRMNCAH&N promotion in conflicts.
METHODS
We identified guidance documents published between 2008 and 2018 through English-language Internet sites of humanitarian response organisations, reviewed them for their scope and assessed their quality with the AGREE II (Appraisal of Guidelines for REsearch and Evaluation II) tool. Additionally, we interviewed 22 key informants on guidance development, dissemination processes, perceived guidance gaps and applicability.
FINDINGS
We identified 105 conflict-relevant guidance documents from 75 organisations. Of these, nine were specific to conflicts, others were applicable also to other humanitarian settings. Fifteen documents were technical normative guidelines, others were operational guides (67), descriptive documents (21) or advice on legal, human rights or ethics questions (2). Nutrition was the most addressed health topic, followed by communicable diseases and violence. The documents rated high quality in their ‘scope and purpose’ and ‘clarity of presentation’ and low for ‘rigour of development’ and ‘editorial independence’. Key informants reported end user need as the primary driver for guideline development and WHO technical guidelines as their main evidence base. Insufficient local contextualisation, lack of inter-agency coordination and lack of systematic implementation were considered problems in guideline development. Several guidance gaps were noted, including abortion care, newborn care, early child development, mental health, adolescent health beyond sexual and reproductive health and non-communicable diseases.
INTERPRETATION
Organisations are motivated and actively producing guidance for SRMNCAH&N promotion in humanitarian settings, but few documents address conflicts specifically and there are important guidance gaps. Improved inter-organisation collaboration for guidance on SRMNCAH&N promotion in conflicts and other humanitarian settings is needed.
Significant global gains in sexual, reproductive, maternal, newborn, child and adolescent health and nutrition (SRMNCAH&N) will be difficult unless conflict settings are adequately addressed. We aimed to determine the amount, scope and quality of publicly available guidance documents, to characterise the process by which agencies develop their guidance and to identify gaps in guidance on SRMNCAH&N promotion in conflicts.
METHODS
We identified guidance documents published between 2008 and 2018 through English-language Internet sites of humanitarian response organisations, reviewed them for their scope and assessed their quality with the AGREE II (Appraisal of Guidelines for REsearch and Evaluation II) tool. Additionally, we interviewed 22 key informants on guidance development, dissemination processes, perceived guidance gaps and applicability.
FINDINGS
We identified 105 conflict-relevant guidance documents from 75 organisations. Of these, nine were specific to conflicts, others were applicable also to other humanitarian settings. Fifteen documents were technical normative guidelines, others were operational guides (67), descriptive documents (21) or advice on legal, human rights or ethics questions (2). Nutrition was the most addressed health topic, followed by communicable diseases and violence. The documents rated high quality in their ‘scope and purpose’ and ‘clarity of presentation’ and low for ‘rigour of development’ and ‘editorial independence’. Key informants reported end user need as the primary driver for guideline development and WHO technical guidelines as their main evidence base. Insufficient local contextualisation, lack of inter-agency coordination and lack of systematic implementation were considered problems in guideline development. Several guidance gaps were noted, including abortion care, newborn care, early child development, mental health, adolescent health beyond sexual and reproductive health and non-communicable diseases.
INTERPRETATION
Organisations are motivated and actively producing guidance for SRMNCAH&N promotion in humanitarian settings, but few documents address conflicts specifically and there are important guidance gaps. Improved inter-organisation collaboration for guidance on SRMNCAH&N promotion in conflicts and other humanitarian settings is needed.
Journal Article > ResearchFull Text
PLOS Med. 2017 September 11; Volume 14 (Issue 9); DOI:10.1371/journal.pmed.1002387
Fabiansen C, Yameogo CW, Iuel-Brockdorf AS, Cichon B, Rytter MJH, et al.
PLOS Med. 2017 September 11; Volume 14 (Issue 9); DOI:10.1371/journal.pmed.1002387
Children with moderate acute malnutrition (MAM) are treated with lipid-based nutrient supplement (LNS) or corn-soy blend (CSB). We assessed the effectiveness of (a) matrix, i.e., LNS or CSB, (b) soy quality, i.e., soy isolate (SI) or dehulled soy (DS), and (c) percentage of total protein from dry skimmed milk, i.e., 0%, 20%, or 50%, in increasing fat-free tissue accretion.
Journal Article > ResearchFull Text
Sci Rep. 2020 August 6; Volume 10 (Issue 1); DOI:10.1038/s41598-020-69987-9
Fabiansen C, Cichon B, Yaméogo CW, Iuel-Brockdorf AS, Phelan KPQ, et al.
Sci Rep. 2020 August 6; Volume 10 (Issue 1); DOI:10.1038/s41598-020-69987-9
Children with moderate acute malnutrition (MAM) are treated based on low weight-for-length z-score (WLZ), low mid-upper arm circumference (MUAC) or both. This study aimed to assess associations of admission criteria and body composition (BC), to improve treatment of MAM. We undertook a cross-sectional study among 6-23 months old Burkinabe children with MAM. Fat-free (FFM) and fat mass (FM) were determined by deuterium dilution and expressed as FFM (FFMI) and FM index (FMI). Of 1,489 children, 439 (29.5%) were recruited by low MUAC only (MUAC-O), 734 (49.3%) by low WLZ and low MUAC (WLZ-MUAC) and 316 (21.2%) by low WLZ only (WLZ-O). Thus, 1,173 (78.8%) were recruited by low MUAC, with or without low WLZ (ALL-MUAC). After adjustments, WLZ-O had 89 g (95% confidence interval (CI) 5; 172) lower FFM compared to MUAC-O. Similarly, WLZ-O had 0.89 kg/m2 (95% CI 0.77; 1.01) lower FFMI compared to MUAC-O, whereas there was no difference for FMI. However, boys included by WLZ-O compared to MUAC-O had 0.21 kg/m2 (95% CI 0.05; 0.38) higher FMI. In contrast, girls included by WLZ-O had 0.17 (95% CI 0.01; 0.33) kg/m2 lower FMI compared to MUAC-O (interaction, p = 0.002). We found that different criteria for admission into MAM treatment programmes select children with differences in BC, especially FFMI.
Journal Article > ReviewFull Text
Lancet. 2021 February 6; Volume 397 (Issue 10273); DOI:10.1016/s0140-6736(21)00133-1
Gaffey MF, Waldman RJ, Blanchet K, Amsalu R, Capobianco E, et al.
Lancet. 2021 February 6; Volume 397 (Issue 10273); DOI:10.1016/s0140-6736(21)00133-1
Journal Article > Meta-AnalysisFull Text
Sci Rep. 2023 June 26; Volume 13 (Issue 1); 10310.; DOI:10.1038/s41598-023-37431-3
Unger HW, Hadiprodjo AJ, Gutman JR, Briand V, Fievet N, et al.
Sci Rep. 2023 June 26; Volume 13 (Issue 1); 10310.; DOI:10.1038/s41598-023-37431-3
In areas of moderate to intense Plasmodium falciparum transmission, malaria in pregnancy remains a significant cause of low birth weight, stillbirth, and severe anaemia. Previously, fetal sex has been identified to modify the risks of maternal asthma, pre-eclampsia, and gestational diabetes. One study demonstrated increased risk of placental malaria in women carrying a female fetus. We investigated the association between fetal sex and malaria in pregnancy in 11 pregnancy studies conducted in sub-Saharan African countries and Papua New Guinea through meta-analysis using log binomial regression fitted to a random-effects model. Malaria infection during pregnancy and delivery was assessed using light microscopy, polymerase chain reaction, and histology. Five studies were observational studies and six were randomised controlled trials. Studies varied in terms of gravidity, gestational age at antenatal enrolment and bed net use. Presence of a female fetus was associated with malaria infection at enrolment by light microscopy (risk ratio 1.14 [95% confidence interval 1.04, 1.24]; P?=?0.003; n?=?11,729). Fetal sex did not associate with malaria infection when other time points or diagnostic methods were used. There is limited evidence that fetal sex influences the risk of malaria infection in pregnancy.
Journal Article > ResearchFull Text
PLOS Med. 2020 December 23; Volume 17 (Issue 12); e1003442.; DOI:10.1371/journal.pmed.1003442
Olsen MF, Iuel-Brockdorf AS, Yaméogo CW, Cichon B, Fabiansen C, et al.
PLOS Med. 2020 December 23; Volume 17 (Issue 12); e1003442.; DOI:10.1371/journal.pmed.1003442
BACKGROUND
Lipid-based nutrient supplements (LNS) and corn–soy blends (CSBs) with varying soy and milk content are used in treatment of moderate acute malnutrition (MAM). We assessed the impact of these supplements on child development.
METHODS AND FINDINGS
We conducted a randomised 2 × 2 × 3 factorial trial to assess the effectiveness of 12 weeks’ supplementation with LNS or CSB, with either soy isolate or dehulled soy, and either 0%, 20%, or 50% of protein from milk, on child development among 6–23-month-old children with MAM. Recruitment took place at 5 health centres in Province du Passoré, Burkina Faso between September 2013 and August 2014. The study was fully blinded with respect to soy quality and milk content, while study participants were not blinded with respect to matrix. This analysis presents secondary trial outcomes: Gross motor, fine motor, and language development were assessed using the Malawi Development Assessment Tool (MDAT). Of 1,609 children enrolled, 54.7% were girls, and median age was 11.3 months (interquartile range [IQR] 8.2–16.0). Twelve weeks follow-up was completed by 1,548 (96.2%), and 24 weeks follow-up was completed by 1,503 (93.4%); follow-up was similar between randomised groups. During the study, 4 children died, and 102 children developed severe acute malnutrition (SAM). There was no difference in adverse events between randomised groups. At 12 weeks, the mean MDAT z-scores in the whole cohort had increased by 0.33 (95% CI: 0.28, 0.37), p < 0.001 for gross motor; 0.26 (0.20, 0.31), p < 0.001 for fine motor; and 0.14 (0.09, 0.20), p < 0.001 for language development. Children had larger improvement in language z-scores if receiving supplements with milk (20%: 0.09 [−0.01, 0.19], p = 0.08 and 50%: 0.11 [0.01, 0.21], p = 0.02), although the difference only reached statistical significance for 50% milk. Post hoc analyses suggested that this effect was specific to boys (interaction p = 0.02). The fine motor z-scores were also improved in children receiving milk, but only when 20% milk was added to CSB (0.18 [0.03, 0.33], p = 0.02). Soy isolate over dehulled soy increased language z-scores by 0.07 (−0.01, 0.15), p = 0.10, although not statistically significant. Post hoc analyses suggested that LNS benefited gross motor development among boys more than did CSB (interaction p = 0.04). Differences between supplement groups did not persist at 24 weeks, but MDAT z-scores continued to increase post-supplementation. The lack of an unsupplemented control group limits us from determining the overall effects of nutritional supplementation for children with MAM.
CONCLUSIONS
In this study, we found that child development improved during and after supplementation for treatment of MAM. Milk protein was beneficial for language and fine motor development, while suggested benefits related to soy quality and supplement matrix merit further investigation. Supplement-specific effects were not found post-intervention, but z-scores continued to improve, suggesting a sustained overall effect of supplementation.
Lipid-based nutrient supplements (LNS) and corn–soy blends (CSBs) with varying soy and milk content are used in treatment of moderate acute malnutrition (MAM). We assessed the impact of these supplements on child development.
METHODS AND FINDINGS
We conducted a randomised 2 × 2 × 3 factorial trial to assess the effectiveness of 12 weeks’ supplementation with LNS or CSB, with either soy isolate or dehulled soy, and either 0%, 20%, or 50% of protein from milk, on child development among 6–23-month-old children with MAM. Recruitment took place at 5 health centres in Province du Passoré, Burkina Faso between September 2013 and August 2014. The study was fully blinded with respect to soy quality and milk content, while study participants were not blinded with respect to matrix. This analysis presents secondary trial outcomes: Gross motor, fine motor, and language development were assessed using the Malawi Development Assessment Tool (MDAT). Of 1,609 children enrolled, 54.7% were girls, and median age was 11.3 months (interquartile range [IQR] 8.2–16.0). Twelve weeks follow-up was completed by 1,548 (96.2%), and 24 weeks follow-up was completed by 1,503 (93.4%); follow-up was similar between randomised groups. During the study, 4 children died, and 102 children developed severe acute malnutrition (SAM). There was no difference in adverse events between randomised groups. At 12 weeks, the mean MDAT z-scores in the whole cohort had increased by 0.33 (95% CI: 0.28, 0.37), p < 0.001 for gross motor; 0.26 (0.20, 0.31), p < 0.001 for fine motor; and 0.14 (0.09, 0.20), p < 0.001 for language development. Children had larger improvement in language z-scores if receiving supplements with milk (20%: 0.09 [−0.01, 0.19], p = 0.08 and 50%: 0.11 [0.01, 0.21], p = 0.02), although the difference only reached statistical significance for 50% milk. Post hoc analyses suggested that this effect was specific to boys (interaction p = 0.02). The fine motor z-scores were also improved in children receiving milk, but only when 20% milk was added to CSB (0.18 [0.03, 0.33], p = 0.02). Soy isolate over dehulled soy increased language z-scores by 0.07 (−0.01, 0.15), p = 0.10, although not statistically significant. Post hoc analyses suggested that LNS benefited gross motor development among boys more than did CSB (interaction p = 0.04). Differences between supplement groups did not persist at 24 weeks, but MDAT z-scores continued to increase post-supplementation. The lack of an unsupplemented control group limits us from determining the overall effects of nutritional supplementation for children with MAM.
CONCLUSIONS
In this study, we found that child development improved during and after supplementation for treatment of MAM. Milk protein was beneficial for language and fine motor development, while suggested benefits related to soy quality and supplement matrix merit further investigation. Supplement-specific effects were not found post-intervention, but z-scores continued to improve, suggesting a sustained overall effect of supplementation.
Journal Article > ResearchFull Text
BMC Nutr. 2016 August 30; Volume 2; DOI:10.1186/s40795-016-0096-0
Cichon B, Fabiansen C, Yaméogo CW, Rytter MJH, Ritz C, et al.
BMC Nutr. 2016 August 30; Volume 2; DOI:10.1186/s40795-016-0096-0
Morbidity plays an important role in the development of and recovery from malnutrition. Morbidity in children with moderate acute malnutrition (MAM) has not been described in detail and it is unclear how morbidity compares to serum levels of acute phase proteins (APPs) which indicate systemic inflammation and which can impede response to therapeutic nutritional interventions. The objective of this study was to describe morbidity in children with MAM and to assess to what extent maternally reported and clinically diagnosed morbidity explain the variation in APPs.