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Malnutrition, Child clinical trials

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NCT ID: NCT06382857 Recruiting - Malnutrition, Child Clinical Trials

Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

Start date: May 2, 2024
Phase: N/A
Study type: Interventional

This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to < 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.

NCT ID: NCT06175273 Recruiting - Pediatric Cancer Clinical Trials

Pediatric Oncology Nutrition Intervention Trial

POINT
Start date: January 31, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Nearly 60% of pediatric patients diagnosed with cancer develop malnutrition caused by a combination of disease burden, side effects of chemotherapy, and the intensity of cancer treatment. These patients are known to have an increased risk of infection, treatment-related toxicity, inferior clinical outcomes, and increased risk of mortality. Malnutrition may progress to cancer cachexia, characterized by anorexia, increased inflammation, decreased fat, and decreased muscle mass with subsequent weight loss, which is associated with decreased overall survival. The goal of the proposed research is to determine changes in body composition, weight status, and nutritional status between common nutrition interventions including oral nutrition supplements (ONS), appetite stimulants, and enteral nutrition (EN) among pediatric cancer patients. A secondary goal of this research is to utilize the findings to develop clinical nutrition guidelines for this patient population. The specific objective of the research proposed is to solve the lack of evidence to adequately treat nutritional deficits in the pediatric oncology population. Without this data, there is a lack of clinical consistency in the initiation and selection of appropriate nutrition interventions to provide a more definitive pathway of care. This study can help formulate a clinical guideline for this patient population before, during, and after treatment.

NCT ID: NCT05836961 Recruiting - Clinical trials for Iron Deficiency Anemia

Impact of Benazir Nashonuma Program (BNP) on Maternal and Child Nutritional Status

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of Benazir Nashonuma Program (BNP) which includes specialized nutritious food (SNF) augmented with specific reproductive health interventions during pregnancy on proportion of low birthweight babies and stunting among children, in low income setting of Pakistan. The study aims to answer if: 1. Utilization of Benazir Nashonuma Program (BNP) among pregnant women is effective in reducing the proportion of low birthweight babies, compared to pregnant women who are not utilizing the program, among low income setting population. 2. Utilization of Benazir Nashonuma Program (BNP) is effective in reducing the proportion of stunting among children, compared to those not utilizing the program, among low income setting population. Participants who are enrolled in the Benazir Nashonuma Program (receiving intervention) and those who are not enrolled (not receiving intervention) will be followed throughout pregnancy till delivery. After delivery mother-baby dyad will be followed for a period of 12 months. Compliance of supplementation will be measured, and outcomes (low birthweight and stunting) observed throughout the follow up.

NCT ID: NCT05791305 Recruiting - Obesity Clinical Trials

Double Duty Interventions and Its Impact on Double Burden of Malnutrition in Children Under Five Years

DBM
Start date: April 10, 2023
Phase: N/A
Study type: Interventional

Background: Double burden of malnutrition is an emerging public health problem among children under-five years due to the inevitable consequences of nutritional transition. Addressing these two contrasting forms of malnutrition (undernutrition and overnutrition) simultaneously brings an enormous challenge to the food and nutrition policies of developing countries like Ethiopia. Children under five ages are more vulnerable to DBM, especially during the first year of their life due to high growth and inadequate diet. Hence, there has been a paradigm shift in thinking to reduce its effect on the health of children. However, interventions that are used to address these different kinds of malnutrition are implemented through different governance and still, they are isolated and disintegrated each other. Therefore, double-duty interventions can tackle the risk of both nutritional problems simultaneously in an integrated approach through nutrition behavior change communication. Objective: Therefore, the main aim of this pilot study is to assess the effect of selected double-duty interventions on the double burden of malnutrition among children under five years in Debre Berhan City, Ethiopia.

NCT ID: NCT05629624 Recruiting - Malnutrition, Child Clinical Trials

Evaluation of Executive Function and Emotional Regulation in Children in Bangladesh

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The study explores the impact of malnutrition at enrollment on executive function (EF) and emotional regulation (ER) in malnourished 1-year-old children and whether specially designed brain directed therapeutic feeds improve EF/ER outcomes at three years of age. The study will detect changes in EF and ER related to nutritional rehabilitation using specially designed ready to use therapeutic feeds (E-RUSF Nutriset) during the repletion phase and maintained for two years until age 3 with enhanced E-SQLNS (small quantity lipid based nutrient supplement) also modified to provide adequate brain directed micro and macronutrients. The investigators hypothesize that standard Bangladeshi designed B-RUSF and SQLNS (Nutriset) do not provide adequate nutrients to supply the brain during the rapid catch-up growth and subsequent early childhood growth phases of rehabilitation from Moderate Acute Malnutrition (MAM). The investigators predict that the children with moderately severe malnutrition treated with E-RUSF followed by 2 years of E-SQLNS will show an exuberance of connections (higher functional connectivity) than children receiving standard Bangladeshi rehabilitation feeds B-RUSF and SQLNS. This prediction is based on past work using EEG to examine the BEAN sample in Bangladesh, and differs from the sample in Boston, where the investigators anticipate that among healthy, normally nourished children, greater connectivity will be associated with better cognitive outcomes. The Core Toolkit will be deployed to the Bangladesh site to define its utility in prediction of executive dysfunction and emotional dysregulation in the context of low-income status, malnutrition and nutritional intervention. All nutritional intervention groups of malnourished children will also receive a set psychosocial stimulation curriculum that has been shown to be effective on severely malnourished children with therapeutic feedings.

NCT ID: NCT05519254 Recruiting - Diarrhea Clinical Trials

Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae

Start date: March 10, 2023
Phase: Phase 3
Study type: Interventional

Children in low- and middle-income countries who are hospitalized for diarrhea and also have malnutrition are at high risk for illness and death in the 6 months period following treatment for diarrhoea despite receiving current guideline recommended diarrhea management (such as oral rehydration solution, or "ORS"). This study will test whether nutritional supplements made from milk (lactoferrin or lysozyme) or a combination of the two (lactoferrin and lysozyme) will prevent children from having repeated diarrhea episodes and help improve their nutrition by improving their stomach health or preventing new disease during this 6-month period. The study is taking place at 7 hospitals in Western Kenya. Six hundred participants will be enrolled if they provide informed consent to participate, are aged 6-24 months, were hospitalized with diarrhea and malnutrition and have been managed by the facility nutritionists and ready to return home. Participation in the study will entail providing information on the child's health history, collection of stool samples, blood, and potentially urine. The caregiver will be provided sachets of the investigational product to take home and mix daily with their child's porridge or other complimentary food, and asked to return to the clinic 4 times in the subsequent 6 months, and also consent to having a community health worker visit their home every two weeks for a follow up visit. The risks to the participant and their caregiver are minimal. The information gained in this study will help us create new treatments and develop new strategies to treat sick children to prevent death and illness.

NCT ID: NCT05442424 Recruiting - Obesity Clinical Trials

Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii

KPRxHawaii
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Children living in food-insecure homes, defined as at some time during the last year their household not having enough food, money, or resources to feed the family experience low intake of fresh fruits and vegetables (FV), and a trajectory for increased risk of obesity and chronic diseases in adulthood. In Hawai'i, a higher proportion of Native Hawaiian (NH) and other Pacific Islander (OPI) children live in food-insecure households when compared with the state average (30% and 50%, respectively vs. 18%) and NHOPI adults suffer disproportionately from chronic disease. Produce prescription programs, provide vouchers to individuals to purchase fresh FV, are promising strategies to improve diet quality and reduce chronic disease risk among food insecure populations. The long-term objective of this research is to reduce nutrition-related health disparities via clinical-community based programming. The Keiki (child) Produce Prescription (KPRx) program was developed and implemented by enlisting University and community researchers and health care providers at the Waianae Coast Comprehensive Health Center (WCCHC). The current study builds on the community-academic partnership to achieve the following specific aim, to measure effectiveness of the KPRx on FV intake, gut microbiome composition, and health related biomarkers in 100 parent-child dyads in the context of household food insecurity from a predominantly NHOPI community in Hawai'i. A community based participatory research approach to carry out a randomized controlled trial that measures the effect of the KPRx on child diet and microbiome, and parent/caregiver diet and health-related biomarkers on 100 parent-child dyads in the context of household food insecurity will be conducted. The community-informed research study will provide data to inform local and state healthcare and nutrition assistance programming policies aimed at reducing food insecurity and health disparities among NHOPI and minority populations.

NCT ID: NCT05269992 Recruiting - Malnutrition, Child Clinical Trials

Childrens Real Food Tolerance Study

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

A prospective, longitudinal, 28-day intervention study evaluating the tolerance, compliance, acceptability and safety to two new enteral tube feed and one new oral nutritional supplement based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement).

NCT ID: NCT05051163 Recruiting - HIV-1-infection Clinical Trials

Strategies to Reduce Mortality Among HIV-infected and HIV-exposed Children Admitted With Severe Acute Malnutrition

REDMOTHIV
Start date: June 14, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study to investigate whether empiric use of an antibiotic with greater antimicrobial sensitivity (ceftriaxone) than standard-of-care (ampicillin plus gentamicin) will reduce mortality among HIV-infected/HEU children admitted to Mwanamugimu Nutrition Unit, Mulago Hospital, Kampala, Uganda.

NCT ID: NCT04785352 Recruiting - Parenting Clinical Trials

Grandi Byen: Supporting Child Growth and Development Through Integrated, Responsive Parenting, Nutrition and Hygiene

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

The premise of this trial is that a combined nutrition (eggs) and parenting behavior intervention (responsive parenting combined with the reinforcement of animal source foods and improved WASH) will synergistically result in improved child growth, development, and reduced enteric disease outcomes over and above a nutrition only intervention and standard well baby care. This study is a 3-arm longitudinal randomized controlled trial (RCT) to compare the following groups for effectiveness in reducing young child stunted growth and enhancing overall development:1) standard well-baby care, (n=200); 2) nutrition intervention (one egg per day for 6 months), (n=200); and 3) multicomponent Grandi Byen intervention (responsive parenting, nutrition, hygiene + one egg per day for 6 months), (n=200). Infants will be enrolled between 6-8 months of age and followed longitudinally for one year.