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NCT ID: NCT05947630 Completed - Orthopedic Disorder Clinical Trials

3D-printing and Acces to Tele Rehabilitation

Imp&acte3D
Start date: May 15, 2018
Phase: N/A
Study type: Interventional

This study will investigate whether 3D printing of orthoses (night splints and AFO/KAFO for walking, further named as dynamic AFO/KAFO) for the lower limbs can help to improve the limited accessibility to orthopaedic devices in developing countries. The 3D printed orthoses will be assessed for effectiveness, cost and feasibility. Measurement and manufacture of the orthoses is also supported remotely via video conferencing.

NCT ID: NCT05893901 Completed - Iron-deficiency Clinical Trials

Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Rural Niger Villages

NigerMPS
Start date: March 13, 2023
Phase:
Study type: Observational [Patient Registry]

The primary hypothesis is that introduction of food-to-food fortified products through a rural Hub-and-Spoke incubator system contributes to an improved food environment and availability of micronutrients to these communities. A secondary hypothesis is that the influence of the rural Spokes can serve to enhance rural food environments through creation of secondary rural spokes that disseminate improved food-to-food fortified products. The overall hypothesis is that a product designed with optimized nutritional characteristics, based on consumer preferences and leveraging local nutrient dense ingredients, can successfully deliver nutrition through sustainable market-driven approaches.

NCT ID: NCT05886179 Completed - Clinical trials for to Contribute to a Better Control of COVID-19 in Children in Niger

COVID-19 IN CHILDREN IN NIGER, 2020

Start date: February 25, 2020
Phase:
Study type: Observational

On January 30, 2020, the WHO declared COVID-19 a global health emergency. Children were affected with less severe forms. Niger had implemented measures in a context where children are a source of contamination. The objective was to determine the factors associated with COVID-19 in children in Niger from February to August 2020 through an analysis of the national database.

NCT ID: NCT05551819 Completed - Malnutrition, Child Clinical Trials

Acceptability of a Microbiome-directed Food in Young Children With Acute Malnutrition

Start date: October 26, 2022
Phase: N/A
Study type: Interventional

This study will compare the acceptability a microbiome-directed food (MDF) with standard formulations of therapeutic/supplementary foods for the treatment of acute malnutrition using a 2 x 2 crossover design.

NCT ID: NCT05070520 Completed - MALARIA Clinical Trials

Efficacy of Antimalarial Drugs Used for the Treatment of Uncomplicated Malaria, Plasmodium Falciparum, at the Agadez, Gaya and Tessaoua Sentinel Sites

Start date: September 1, 2020
Phase: Phase 4
Study type: Interventional

In Niger, malaria is a major public health problem. It is the main cause of morbidity and mortality among children. The management of malaria cases is based on the principle of early diagnosis and rapid treatment with effective drugs. It is confronted with the appearance of strains resistant to antimalarial drugs, hence the need to monitor antimalarial drug sensitivity. The study was conducted in three regions representing epidemiological strata of the country: Agadez (Centre de santé Intégré of Dagamanet in the Health district of Agadez), Maradi (Centre de santé intégré of Guindaoua in Tessaoua) and Dosso (Centre de santé Intégré centre in Gaya). The protocol used is the WHO standardized protocol of 2009. Artemether/Lumefantrine (AL) was administered with a 28-day follow-up in children aged 3 months to 15 years. A Polymerase Chain Reaction (PCR) correction is planned to differentiate between treatment failure and re-infestation as well as a study of genes responsible for resistance on the main drugs used.

NCT ID: NCT04698070 Completed - Clinical trials for Acute Malnutrition in Infancy (Disorder)

Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Niger (OptIMA Niger)

Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Acute malnutrition (AM) is a continuum condition, arbitrarily divided into severe and moderate categories (SAM, MAM) which are managed separately, with programs overseen by different agencies with different products and supply chains. Such separation complicates delivery of care, contributes to poor program performance, and creates confusion among caregivers. Reduction in the mortality burden from AM will stem from improved simplicity, efficiency and cost-effectiveness of current protocols. Eligibility for SAM treatment in the current Niger protocol is complex. It is determined by 3 independent criteria: nutritional oedema, Mid-Upper Arm Circumference (MUAC) < 115 mm or weight-height Z score (WHZ) <-3. Also, the Ready to Use Therapeutic Food (RUTF) ration in Niger protocol (130-200 kcal/kg/d) is paradoxical. The amount of RUTF prescribed in the first weeks of treatment is often less than what given to child reaching recovery (MUAC > 125 and WHZ >-2), because weekly ration is determined by the child's weight. Rate of weight gain is highest in the first two weeks of treatment, then plateaus - suggesting no benefit of increased RUTF ration at the end of treatment. Progressive reduction is a more rational use of RUTF and this supplement is equally effective for SAM and MAM. This community-based non-inferiority trial will compare two strategies for the treatment of AM to the Niger protocol for SAM and MAM. The Optimizing treatment for acute MAlnutrition (OptiMA) strategy uses MUAC < 125 mm or nutritional oedema as admission criteria and optimizes RUTF by adapting doses to the degree of malnutrition. RUTF dose for MUAC < 115 mm or oedema is 170 kcal/kg/d and progressively reduces to 75 kcal/kg/d as MUAC increases. The Combined Protocol for Acute Malnutrition Study (ComPAS) uses the same eligibility criteria like OptiMA, but simplifies more the RUTF ration by providing 1000 kcal/d for children with oedema or MUAC < 115 mm and 500 kg/d for children with MUAC 115-124 mm. Children are considered recovered if they have 2 consecutive weekly MUAC measures ≥ 125 mm. Children will be individually randomized to treatment in one of the 3 study arms and will attend clinic visits weekly until nutritional recovery. After discharged, they will be monitored monthly via a nurse-conducted home visits until 6 months post-inclusion. The trial arms will be compared using a composite outcome indicator that includes vital status, anthropometric measures and relapse following the index AM episode. The hypothesis is that simplified strategies could substantially increase the number of children in care compared to current SAM programs without requiring additional RUTF or staffing while maintaining recovery rates in line with current programs.

NCT ID: NCT03474276 Completed - Clinical trials for Moderate Acute Malnutrition

Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old

MALINEA
Start date: January 31, 2018
Phase: Phase 3
Study type: Interventional

The aim of this open-label randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic and Senegal) is to compare three strategies of renutrition for moderate acute malnutrition (MAM) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment. Cognitive development of children (Senegal) will also be studied and compared.

NCT ID: NCT03338244 Completed - Childhood Mortality Clinical Trials

Mortality Reduction After Oral Azithromycin Contingency: Mortality Study

MORDORIIMortY5
Start date: October 20, 2017
Phase: Phase 4
Study type: Interventional

MORDOR was a cluster-randomized placebo controlled trial that assessed the efficacy of mass azithromycin distributions for the prevention of childhood mortality. All communities were subsequently treated with mass azithromycin for one year. The present trial re-randomized communities to azithromycin or placebo for the fourth and fifth year of the study.

NCT ID: NCT03280082 Completed - Malnutrition Clinical Trials

Use of MUAC as Basic Criterion for Admission, Follow-up and Exit From the Ambulatory Nutrition Program

MUAC120
Start date: June 25, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to provide comprehensive documentation of the relevant results and operational implications of this new model using Mid-Upper Arm Circumference (MUAC) as the single anthropometric criterion for admission, monitoring and exit of non- complicated in Niger.

NCT ID: NCT03226730 Completed - Contraception Clinical Trials

Evaluating Household Visits and Small Groups to Increase Contraception Use Among Married Adolescent Girls in Rural Niger

IMPACT-RMA
Start date: May 2016
Phase: N/A
Study type: Interventional

This study entails a quasi-experimental, mixed-methods (i.e., complementary quantitative and qualitative) outcome evaluation to assess the efficacy of the Reaching Married Adolescents (RMA) Interventions developed and implemented by Pathfinder International to increase contraception use and contraception use intentions among married adolescent girls ages 13-19 in three rural districts of the Dosso region of Niger. Intervention models (gender-synchronized household visits and small groups) will be tested using a randomized 4-arm outcome evaluation design; Arm 1 will receive household visits, Arm 2 will receive small groups; Arm 3 will receive household visits plus small groups, and Arm 4 will serve as the control group and will not receive any intervention. The quantitative component will consist of collecting quantitative baseline, 16-months follow-up, and 27-months survey data from randomly selected married adolescent girls (n=1200) and their husbands (n=1200) who are participating in each Arm of the study. Qualitative elements will include ethnography at two time points and semi-structured in-depth interviews half way through intervention implementation. A costing and cost effectiveness analysis will also be conducted to evaluate which intervention provides the largest gain in the primary outcomes for each dollar spent.