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NCT06207071
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.
NCT01239693
The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating women and their infants from 6 to 18 months of age. In control groups, participants will receive either iron+folate tables during pregnancy only or multiple micronutrient tablets during pregnancy and first six months of lactations. The main hypothesis to be tested suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and the first 6 months of lactation is higher than the mean LAZ score of same age infants who received no dietary supplements and whose mothers received iron-folate supplementation during pregnancy only. To detect the long-term effect of the LNS supplementation, we now propose to conduct a follow-up study when the children are 9 years old, to see if the intervention had effect on children's growth, cardiometabolic and respiratory status and neurocognitive development.
NCT05108675
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.
NCT05584969
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.
NCT03385252
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.
NCT03181178
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.
NCT03040375
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
NCT01333995
Child undernutrition remains a highly prevalent condition in low and middle income countries and a major portion of the global burden of childhood malnutrition is found in South Asia with an estimated 74 million children living with chronic malnutrition (stunted growth) in this region. This burden of malnutrition accounts for approximately 50% of under five child deaths in developing countries. The risk of child death is also related to the severity of malnutrition and progressively increases the more the child's growth deviates from WHO Growth Standard, e.g. children with height-for-age \<-3 Z scores from the standard have a four fold increased mortality risk compared to children within one Z score of the growth standard mean. Underweight in children for 18.7% of the global disability-adjusted life years in children less than five years of age. Childhood malnutrition is a pervasive problem in Bangladesh with 43% of children less than five years stunted in 2004 and 38% in urban child populations. An establish approach to promoting appropriate breastfeeding practices is through the use of local peer counsellors to provide information and to support to mothers. A recent study has conducted on pioneering research on this approach in Bangladesh.. The main aim of the study is to use a Cluster Randomized Control Trial (CRCT) to collect high-level evidence of whether peer counselling of women to promote appropriate breastfeeding and complementary feeding can improve feeding practices, child growth and reduce the prevalence of malnutrition in their children. The investigators will use a community-based Cluster Randomized Control Trial (CRCT) to examine the impact of a peer counselling infant feeding education program starting in the third trimester of pregnancy to one year after delivery, to improve child feeding practices, child growth and reduce the prevalence of malnutrition in their children. This will result in two study groups. The outcome assessments will be made on a cohort of infant-mother dyads measured at baseline and at follow up visits because the investigators expect a likely high correlation between baseline and follow up outcome measures, thus making this approach the most efficient study design. Outcome assessments will be conducted with all the mother-infant pairs recruited in the community clusters in the study, with an expected total of 1950 mother-infant days (975 in each treatment group). The peer counseling education will be offered to eligible pregnant women identified by household surveys over 3 months in each community cluster in the intervention group. Using a similar approach to recruitment, a cohort of mother-infant dyads, who will receive standard maternal and child health care programs, will be identified in the control clusters. Data will be collected on anthropometry, feeding practices and hygiene and caring practices etc. The investigators will report the results for 2-sided 5% tests for the primary trial outcome. Secondary analyses will examine each outcome variable (stunting, height-for-age, feeding patterns, and mean nutrient intakes) taking account of the repeated measurements within children by using separate mixed models. The investigators will use linear mixed models for continuous outcomes (e.g. height-for-age Z) and generalized linear mixed models for non-continuous outcomes (e.g. logistic mixed models for binary outcomes e.g. percentage exclusively breastfeeding). It is expected that the publications from this research will have substantial impact on child health and will help with the development of public health nutrition policies for children in South Asia and will be widely cited.