View clinical trials related to Infant Malnutrition.
Filter by:This proposed randomized controlled trial aims to investigate the effect of maternal egg consumption during pregnancy on birth length. The study hypothesizes that mothers who consume two eggs a day will have children whose birth length is significantly longer than those born to mothers who consume a typical diet. Pregnant women (n=956) from Nyagatare District in Rwanda will be randomized into one of two study arms: a treatment group (T1) or a control group (T2). Mothers in the treatment arm will receive an animal source food (ASF) supplement of two eggs per day, from enrollment during first trimester through childbirth. Mothers in the control arm will be asked to continue consuming their typical diet. Mothers in both arms will receive standard information, education, and communication about health and nutrition during pregnancy and after birth. All enrolled mothers in the study will also receive up- to-date standard care for pregnant women, as outlined by the Government of Rwanda, a fortified blended flour if they are not already receiving it from the government, a mobile phone with cellular connection, health insurance if they do not already have, and compensation for traveling to a Community Health Worker's home every day for study engagement. All women will receive ultrasound examinations three times during pregnancy, as well as blood tests for anemia. Women in the control arm will receive additional compensation at childbirth. Women will be recruited and enrolled during first trimester (9-14 weeks gestational age), as confirmed by ultrasound. At enrollment, baseline data will be collected on socio-economic factors, maternal health, maternal diet, and fetal growth. Additional markers for maternal health and child growth and development, including markers for fetal brain development, will be collected during two targeted ante-natal clinic visits (20-26 weeks and 30-34 weeks), where all women will receive ultrasound assessment in addition to their typical clinical assessment. At childbirth, maternal and child health data will be collected, including birth outcomes, child anthropometry, and indicators of neurodevelopment. Additional follow-up of maternal and child health indicators, including maternal depression, and infant and young child feeding practices, will be collected at 1 month and 6 months of child age.
Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.
The goal of this randomized trial was to examine whether a peer-to-peer integrated intervention using Care Groups combining nutrition education and social support will improve infant growth and complementary feeding practices among refugees in the West-Nile region in Uganda. The aims of the study were to 1) determine the relationship of the intervention using the Care Group model on complementary feeding of infants, and 2) investigate the effects of a peer-led integrated nutrition education intervention using the Care Group model on growth among infants of refugees in Uganda. Pregnant mothers (390) in their 3rd trimester were enrolled in a peer-led nutrition education intervention using the Care Group model. One treatment arm had moms only in the Care Groups while the other treatment arm had both moms and dads in the groups. Each study arm had a total of 10 Care Groups with 10-20 participants each. The control arm equally had 10 groups, however, did not receive the intervention. Each of the treatment arms participated in a biweekly integrated nutrition training hypothesized to effect behavioral change in infant feeding practices. The biweekly training started in March 2022 and ended in December 2022 with data collection at four-time points during the study (baseline, midline-I, II, and endline). Infant complementary feeding was evaluated using the World Health Organization & UNICEF guidelines. Infant growth was assessed using length-for-age z-scores, weight-for-age z-scores and weight-for-length z-scores. The Medical Outcomes Study (MOS) Social Support Index was used as a proxy to measure maternal social support. Effects of Care Group intervention on infant complementary feeding and growth were tested by study arm compared to the control arm.
Nutritional status during pregnancy plays an important role in maternal health and birth outcomes. While few factors impacting nutritional status during pregnancy have been identified, studies of undernutrition in children have revealed a key role for the gut microbiome. Remarkably, studies examining the dynamics of the maternal gut microbiome before and during pregnancy and its impact on birth outcomes are limited. This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby. The gut microbiome is the totality of microorganisms (e.g. bacteria, viruses, fungi) living in the gastrointestinal tract. This study will focus on married pregnant women 24 years and younger living in Matiari District in Pakistan. The focus is on younger women due to their vulnerability to undernutrition. Pregnant participants, and upon delivery, their newborns will be followed throughout pregnancy and for a year afterwards. Throughout this period, the investigators will collect stool samples, rectal swabs, blood samples, health assessments, nutritional and dietary assessments and birth/ labour details. The goal is to define the relationship between a mother's nutritional status and her microbiome dynamics during pregnancy and how they contribute to the birth outcomes and growth of her newborn. Investigators hypothesizes that alterations of the microbiota in the maternal gut (dysbiosis) is exacerbated by nutritional status or pathogen exposure during pregnancy. This impacts weight gain because of impaired nutrient absorption, and can lead to corresponding negative birth outcomes.
Child undernutrition is a worldwide public health problem that has persisted in African countries. For instance, the most recently reported prevalence rates of stunting (38%), underweight (24%), and wasting (10%) among children under the age of five in Ethiopia is higher than the global prevalence. The causes of undernutrition are classified in the following manner: immediate causes, such as inadequate dietary intakes; underlying causes, such as household food insecurity and inadequate care and feeding practices; and basic causes, which involve the household's inadequate access to education, employment, and income, among others. Evidence has demonstrated that nutrition education interventions (NEI) may influence both underlying and immediate causes of child undernutrition. For instance, nutrition education interventions have the potential of preventing the underlying causes of child undernutrition by improving mothers' knowledge in care and feeding practices, and further improving the quality and quantity of dietary intake, which is considered an immediate cause of child undernutrition. Moreover, nutrition education interventions designed to improve infant and young child feeding (IYCF) practices, such as dietary diversity, frequency, and adequacy, are considered a high impact strategy that may substantially reduce stunting. Preliminary data from Hawassa University (collaborating institution in this project) demonstrated that approximately 86% of the children residing in Arsi Negele, Wondo Genet, and Dale districts in Oromia and Southern Nations, Nationalities and Peoples' (SNNP) regions in Ethiopia do not receive adequate complementary feeding practices. Such lack of optimal complementary feeding practices may compromise a child's growth, development, and survival. Therefore, there is a critical need for improving child complementary feeding practices to promote their well-being and adequate nutritional status. Thus, the main purpose of this study is to improve child feeding practices and related nutritional status by improving the mother's knowledge, attitudes, and practices (KAP) of complementary feeding practices for their children aged six to 23 months in three woredas located in Oromia and SNNP. It is hypothesized that after the NEI mothers will improve their children' dietary diversity, frequency and adequacy.
Background: Millions of children in low resource settings are at high risk of poor development due to factors such as undernutrition, inadequate stimulation and maternal depression. Evidence based interventions to address these risk factors exist, but often as a separate and overlapping packages delivered through disjointed systems, therefore posing problems in scale-up. A common elements approach based intervention that combines evidence-based elements from packages of care addressing early stimulation, responsive feeding and maternal distress have been developed. Objectives: The current study aims to develop an online training curriculum to train lay health workers in common elements based intervention to improve maternal psychological well-being and improve mother-infant interaction among distressed mothers in low resource rural community settings of Pakistan. The impact of intervention on maternal well-being, infant growth, nutrition and development will be evaluated at 12-months post-partum. Method: A two arm, single blind, individual randomized controlled trial (RCT) will be carried out in the community settings of the rural sub-district of Gujar Khan in Rawalpindi, Pakistan. 250 Pregnant women in third trimester of pregnancy, screened positive for psychological distress on Self-Reporting Questionnaire (SRQ), cut-off score ≥ 9, will be randomized on 1:1 allocation ratio into intervention (n=125) and Treatment as Usual (TAU) arms (n=125). The participants in the intervention arm will receive 15 monthly sessions of intervention by community volunteers at home. First three sessions will be delivered in the third trimester of pregnancy followed by one monthly session for 12 months. The primary outcome will be caregiver-infant interaction at 12-months post-partum. The maternal secondary outcomes include maternal psychological wellbeing, quality of life, social support and empowerment. Maternal outcomes will be measured at baseline, 6-months and 12-months post-partum. Infant secondary outcomes include growth, nutrition and development and will be measured at 12 months. A mixed-methods process monitoring and evaluation will be conducted to inform the feasibility of intervention delivery. Discussion: The outcomes of the study will be a common-elements based online training curriculum for training of community volunteers in intervention to improve maternal psychological well-being and mother-infant interaction in low resource rural community settings at-scale.
The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts. The present proposal therefore will 1) perform a formative study to identify the most suitable (acceptability and utilization) BEP supplement for pregnant women in rural Burkina Faso (phase 1) and 2) evaluate the efficacy of this supplement to improve birth weight, fetal and infant growth (phase 2). The nutritional composition of the BEP supplement was established during an expert convening at the BMGF in September 2016. Private sector partners will prepare the supplements in the selected forms with the recommended nutrient composition.
The Mazira Project is a study of the effect of egg consumption on growth, development and gut health of infants in Malawi. The study randomly assigns infants to receive one egg per day over six months or to receive an equivalent value of food at the end of six months. Growth, achievement of developmental milestones, gut microbiome composition and other measures of nutritional status are compared between the two groups to determine whether regular egg consumption benefits Malawian infants.
Prevention of malnutrition in infants and children requires access and intake of nutritious food starting at birth with exclusive breastfeeding for the first 6 months of life, breastfeeding in combination with complementary foods from 6-24 months of age, access to clean drinking water and sanitation, access to preventive and curative health care (including prenatal). In Ghana, the Demographic and Health Survey of 2014 reports rates of stunting, wasting and underweight in children aged 0-59 months are 28%, 14% and 9% respectively. Furthermore, height for age starts dropping from age 4-6 months with children aged 6-23 months being more likely to be stunted (40%) than those below 6 months (4%). Infant and young child feeding data show that for breast-fed children ranging from 6 months through 35 months of age, cereals are predominantly the first foods introduced in the diet (6-8 months of age). As the child grows older, consumption of fruits rich in Vitamin A, other fruits and vegetables and meat, fish, poultry and eggs are reported by the mothers. The Demographic and Health Survey (DHS) found that the proportion of breast fed children aged 6-23 months who received a recommended variety of foods the minimum number of times per day increases with child's age from 28% in children 6-8 months to 50% in children aged 18-23 months. The study objective is to examine the effect of providing a macro- and micro-nutrient fortified complementary food supplement (KokoPlusTM) on growth and nutritional status of Ghanaian infants.
Undernutrition and poor cognitive development affect many children under 5 in developing countries, who are exposed to multiple risk factors including poverty, malnutrition, poor health, and unstimulating home environments. The optimum development and growth of young children requires affection and responsiveness from the mother/caregiver, cognitive stimulation, good nutrition and infection control. In Bangladesh, stimulation at home is generally poor and contributes to children's poorer development. It is important to show that psychosocial stimulation programmes through home visits integrated into the feeding programmes can benefit children's growth and development. This study will help to fill this evidence gap about effective interventions to improve infant and young child growth and development in Bangladesh. Considering the high prevalence of undernutrition and low prevalence of stimulating environments in Bangladesh, it is important to show evidence that integrating infant feeding counselling and psychosocial stimulation activities result in optimum child growth & development. To determine if combined infant feeding counselling and psychosocial stimulation programme (promoting mothers positive parenting) starting in the 3rd trimester of pregnancy, further improves: children's cognitive, motor and language development along with growth and mothers' child rearing and child-feeding knowledge and practices compared to peer counselling alone or usual health messages only. We used a community-based CRCT to examine the impact of a peer counselling infant feeding education program with psychosocial stimulation starting in the third trimester of pregnancy to one year after delivery, to improve child growth and cognition, language, behaviour and psychomotor development compared to a control group receiving usual health messages. The outcome assessments were made on a cohort of infant-mother dyads measured at baseline and at follow up visits. Outcome assessments were conducted with all the mother-infant pairs recruited in the community clusters in the study, with an expected total of 334 mother-infant dyads (167 in each treatment group).The main outcomes are children's growth, cognition, language, behaviour and psychomotor development