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Growth Failure clinical trials

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NCT ID: NCT04587271 Completed - Malnutrition Clinical Trials

Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children

Start date: July 21, 2021
Phase: N/A
Study type: Interventional

Studies to date on the effects of Moringa oleifera in diabetes and anemia and animal studies that examine the utility of moringa for increased milk and litter yield are of small scale, however high-quality large-scale placebo or case-controlled clinical trials to define the impact on infants of moringa leaf powder consumption by breastfeeding mothers are lacking. Moringa has a traditional and agricultural history of use as a galactagogue; despite this and its incorporation into products such as Mother's Milk Tea© and placement on NIH LactMed Lactation Database, this property has not been studied in large clinical trials nor in populations dependent on breastmilk such as in Kisumu, Kenya. This study will improve and add to existing knowledge of moringa's effect on human breastmilk and will provide novel information on the effect of moringa supplementation to lactating mothers on their infant's intestinal inflammation and health. After trial registration, the study was modified to include infant follow up to 18 months for some measures and the children's groups were removed. Although the study was modified to an 18 month follow up, the data were not able to be collected. Further understanding of the acceptability of moringa leaf in a staple food of porridge and more the effect of moringa supplementation on infant and childhood growth, nutrition, and intestinal and systemic inflammation may translate in the future to the cultivation of moringa at the community or household level as an effective resource for the improvement of childhood undernutrition.

NCT ID: NCT03891589 Completed - Nutritional Status Clinical Trials

Optimized Complementary Feeding With or Without Home Fortification Prevents Decrease of Micronutrient and Growth

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Malnourished among under-five children characterized by growth faltering is a public health concern in Indonesia. It requires serious action from the governments because of the prevalence of underweight, stunting, and wasting are increasing. These impacts are irreversible resulting in the low quality of future human resources. Several studies showed that growth faltering among under-five children starts at age six months when the amount of breastmilk reduced, complementary feeding initiated, and risk for infection is increased. A rapid growth phase also causes growth faltering at age 6-24 months. The inadequate amount and low quality of food during this period can also lead to reducing nutritional status. The Indonesian Government released a national policy in 2013 to address undernutrition among under-five children called the Indonesia President Regulation No. 42/2013 regarding national movements on the acceleration of nutritional programs to address micronutrients deficiency among under-five children by providing micronutrient powder (MNP) (called Taburia) for children aged 6 - 59 months. Our literature review documented that there is no study ever conducted to evaluate the effectiveness of MNP (Taburia) in improving the weight and height of the children. Moreover, behavioral modification interventions to promote food diversification to improve nutrient intake and to prevent micronutrient deficiency are also never conducted. Based on the rationale and study concept, the following hypotheses are 1). Promotion of optimized complementary feeding along with or without multi-micronutrient powder or MNP (namely taburia) can prevent reductions in nutrient intake and density; serum ferritin and zinc levels; and anthropometric z-score index compared to controls, and 2) provision of MNP can prevent reductions in nutrient intake and density; serum ferritin and zinc levels; and anthropometric z-score index compared to controls.

NCT ID: NCT03563391 Completed - Clinical trials for Congenital Heart Disease

A Study to Evaluate the Effects of a New Formula on the Growth, Safety and Tolerance of Infants With Growth Failure

Start date: January 30, 2018
Phase: N/A
Study type: Interventional

This study is a prospective, open-label, multi-site, growth, safety and tolerance study to evaluate a NF (New Formula). A minimum of 45 evaluable infants with confirmed growth failure will be enrolled. Growth failure for 30 infants will be due to congenital heart disease and 15 infants due to other organic or non-organic causes. Study infants (in-patient or living with parents/ caregivers at home) will be fed the NF for a period of up through 16 weeks or until the time the infant subject meets criteria for switching to a lower calorie density formula, relative to baseline in infants with growth failure. Weight, height, head circumference and mid upper arm circumference will be measured regularly throughout the study. NF and other food intake, tolerance and stool diaries will be completed regularly. Serious adverse and adverse events will be monitored throughout the study. Infants will be evaluated, at each study visit, for criteria to switch to a lower calorie density formula. The primary objective is to improve weight-for-age z score relative to baseline. The secondary objectives are to improve weight-for-length, length-for-age, head circumference-for-age, mid upper arm circumference-for-age, weight velocity and length velocity z scores relative to baseline.

NCT ID: NCT02842645 Completed - Clinical trials for Mental Health Disorder

Growth-Health and Development in Children Exposed to Drugs During Pregnancy

Start date: February 2011
Phase: N/A
Study type: Observational

"Children exposed to alcohol or drugs during pregnancy: Growth, health and development" Background Children exposed to drugs during pregnancy are at risk of developmental disorders. The scope and size of this problem is poorly known in Norway. Alcohol has a known teratogenic effect on the fetus. How other drugs affect the fetus, is associated with more uncertainty. Withdrawal in the neonatal period has been perceived as the main problem. There is less knowledge about long-term outcome of exposure to drugs during pregnancy. Aim The aim of the study is to investigate the physical and mental health of children exposed to drugs during pregnancy. Identify the children's need for measures in the home and school, and how many of the children who are taken care of in fostercare. A sample of the children will be offered radiological examination of the brain (f-MRI). The purpose is to study the relationship between exposure to drugs, child development, environment and organic brain dysfunction. Design The project is a quantitative study. The relationship between exposure to drugs and development will be measured by questionnaires, clinical examination, neuropsychological tests and radiological examination (f-MRI). Children aged 2-15years who were referred, examined or treated for drug related problems at the Department of Pediatrics, Haukeland University Hospital will be invited to participate in the study. Information retrieval and examination of the children are expected to be completed during 2011. Data analysis and further processing of data are expected to be completed during 2013.

NCT ID: NCT02657629 Completed - Clinical trials for Hypoplastic Left Heart Syndrome

Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants

Start date: December 2009
Phase: N/A
Study type: Interventional

The purpose of the study is to determine if a continuous feeding regimen as compared to an intermittent bolus feeding regimen leads to improved weight gain in infants with hypoplastic left heart syndrome (HLHS) after stage 1 procedures.

NCT ID: NCT02515266 Completed - Premature Birth Clinical Trials

Additional Protein Fortification in Extremely Low Birth Weight Infants

PROTSUP
Start date: May 2015
Phase: N/A
Study type: Observational

Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Optimal nutritional care is required to reduce the initial weight loss and further growth deficit. The quantitative objective is to achieve growth that is at least equivalent to that of the fetus (on average 15 g/kg.day (12-18 g/kg.day according to gestational age). Children often grow during difficult 10-15 first days of life, so they accumulate a delay that should compensate them secondarily. Therefore, optimum postnatal growth is rather 20 g/kg.day than 15 g/kg.day. Individualized fortification of human milk (HM) has been proposed to optimize postnatal growth. Specifically, the lack of protein intake is responsible for sub-optimal postnatal growth in preterm infants. The objectives of this study are to determine the effectiveness of additional protein fortification (APF) in terms of short-term growth along with the proportion of extremely low birth weight (ELBW) infants requiring APF.

NCT ID: NCT02419599 Completed - Growth Failure Clinical Trials

High vs Standard Energy Children's Drink Study

Start date: August 2015
Phase: N/A
Study type: Interventional

This study is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children.

NCT ID: NCT02136966 Completed - Growth Failure Clinical Trials

Joint Infant and Young Child Nutrition Program and Malnutrition Prevention

Start date: November 2014
Phase: N/A
Study type: Interventional

Study title: Joint Infant and young children nutrition program in Burkina Faso: Impact evaluation Hypothesis: The fortification of complementary foods associated with a counseling on feeding practices for infants and young children prevents malnutrition in 6-23 months-old children. Objective: to assess the effectiveness of a promotional care package in preventing malnutrition among children aged 6-23 months.

NCT ID: NCT01909661 Completed - Tolerance Clinical Trials

Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas

JUNGLO
Start date: March 2013
Phase: Phase 2
Study type: Interventional

The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.

NCT ID: NCT01883193 Completed - Mortality Clinical Trials

Women First: Preconception Maternal Nutrition

WF
Start date: August 2013
Phase: N/A
Study type: Interventional

Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain the benefits of ensuring optimal maternal nutrition before conception and providing an evidence base for programmatic priority directed to minimizing the risk of malnutrition in all females of reproductive age.