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Growth clinical trials

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NCT ID: NCT04283799 Completed - Preterm Infant Clinical Trials

Using a New Human Milk Fortifier to Optimize Feeding

Start date: March 16, 2020
Phase: N/A
Study type: Interventional

This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.

NCT ID: NCT04281563 Completed - Growth Clinical Trials

Medium-chain Triglyceride Oil Massage on Growth in Preterm

Start date: July 7, 2017
Phase: N/A
Study type: Interventional

Aim: To explore the effect of medium-chain triglyceride (MCT) oil massage on growth in preterm infants. Methods: This randomized controlled trial was conducted in the newborn center of a regional hospital in Taiwan. Preterm infants weighing between 1500 and 2000 g were recruited and randomly assigned to three groups: the MCT oil massage, massage alone and no massage groups. The massages were given three times per day for 7 consecutive days. Weight, length and head circumference were measured in the three groups at birth and on study days 1 to 7.

NCT ID: NCT04143204 Completed - Growth Clinical Trials

Nutrition and Growth in Very Preterm Infants

Start date: August 1, 2019
Phase:
Study type: Observational

This study aims to explore the relation of early nutritional intake, especially oral nutrition intake, with growth and body composition among very preterm or very low birth weight infants.

NCT ID: NCT04055363 Completed - Growth Clinical Trials

Human Milk Oligosaccharides (HMOs) Post-market Study on Infants

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

Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to monitor the safety & tolerance of HMOs-supplemented formulas in larger and diverse infant populations; to assess the performance of HMOs-supplemented formulas in mixed-fed infants, a population that was not studied in previous RCTs but likely represents a relatively common feeding regimen. Finally, considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas and compare with breastfed infants data.

NCT ID: NCT03653754 Completed - Child Development Clinical Trials

Growth and Body Composition in Children

Start date: April 16, 2018
Phase:
Study type: Observational

This study is planned to measure and compare body composition indexes and growth between typically developing children and those with disabilities in South Korea for understanding the nutritional and growth status.

NCT ID: NCT03537365 Completed - Clinical trials for Necrotizing Enterocolitis

Bovine Colostrum as a Fortifier Added to Human Milk for Preterm Infants

FortiColos
Start date: December 4, 2017
Phase: N/A
Study type: Interventional

Very preterm infants (<32 weeks gestation) with very low birth weight (VLBW, <1500 g) show immaturity of organs and have high nutrient requirements forgrowth and development. In the first weeks, they have difficulties tolerating enteral nutrition (EN) and are often given supplemental parenteral nutrition (PN). A fast transition to full EN is important to improve gut maturation and reduce the high risk of late-onset sepsis (LOS), related to their immature immunity in gut and blood. Conversely, too fast increase of EN predisposes to feeding intolerance and necrotizing enterocolitis (NEC). Further, human milk feeding is not sufficient to support nutrient requirements for growth of VLBW infants. Thus, it remains a difficult task to optimize EN transition, achieve adequate nutrient intake and growth, and minimize NEC and LOS in the postnatal period of VLBW infants. Mother´s own milk (MM) is considered the best source of EN for VLBW infants and pasteurized human donor milk (DM) is the second choice, if MM is absent or not sufficient. The recommended protein intake is 4-4.5 g/kg/d for VLBW infants, when the target is a postnatal growth similar to intrauterine growth rates. This amount of protein cannot be met by feeding only MM or DM. Thus, it is common practice to enrich human milk with human milk fortifiers (HMFs, based on ingredients used in infant formulas) to increase growth, bone mineralization and neurodevelopment, starting from 7-14 d after birth and 80-160 ml/kg feeding volume per day. Bovine colostrum (BC) is the first milk from cows after parturition and is rich in protein (80-150 g/L) and bioactive components. These components may improve gut maturation, NEC protection and nutrient assimilation, even across species. Studies in preterm pigs show that feeding BC alone, or DM fortified with BC, improves growth, gut maturation and NEC resistance during the first 1-2 weeks, relative to DM, or DM fortified with conventional HMFs.On this background, we hypothesize that BC, used as a fortifier for MM or DM, can induce similar growth and better NEC and LOS resistance, than conventional fortifiers. A pilot trial is required 1) to test the feasibility and initial safety of BC as a fortifier (e.g. similar growth rates and clinical variables as conventional fortification), 2) to calculate the sample size for a later, larger RCT with NEC +LOS as the primary outcome, and 3) record paraclinical outcomes associated with type of fortifier.

NCT ID: NCT03456934 Completed - Growth Clinical Trials

Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease

BabyGrowth
Start date: August 7, 2017
Phase: N/A
Study type: Interventional

The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.

NCT ID: NCT03303755 Completed - Cerebral Palsy Clinical Trials

Predictive Models of Weight and Height for the Evaluation of the Growth of Children and Adolescents With Cerebral Palsy

Start date: April 1, 2014
Phase:
Study type: Observational

Cerebral palsy (CP) is the most frequent disability in children. The vast majority of these patients are malnourished. In this population, there are practical difficulties to perform a nutritional and growth assessment which makes it difficult to treat and follow up, because of the lack of reference growth in Argentina, and the difficulty in taking anthropometric measurements of weight and height because of their motor compromise, posture and muscle tone. The main objective is to design and validate predictive models for the nutritional and growth assessment of children and adolescents with CP and instruments for estimating weight and height from body segments, in order to improve care, quality of life of these patients to promote their social inclusion. Material and method: It will be an observational, descriptive and cross-sectional study. There will be two parts of the study, in the first part the population will be healthy children from 2 to 18 years old from Cordoba, Argentina. The sample size was calculated based on growth WHO standards data, for α=0.05 and 1-β=0.80, creating an stratified sampling divided in 16 age groups for each age. This first part will help to establish which body segments to use. In the second part, the population will be children and adolescents from 2 to 18 years old with diagnosis of CP from Córdoba, Argentina. A stratified sequential sampling shall be performed. The sample size will be 192 patients, 12 per age stratum. The variables studied will be: weight, height, body segments, sex, age, CP type, feeding path and type of feeding. For the analysis of the data the normal continuous variables will be described in means with their respective standard deviations and those of non-normal distribution in medians with their ranges. For the development of the predictive equations using body segments measures, a generalizable linear regression model will be used. The correlation coefficient r, determination R2 and test of F will be calculated with p <0.05. To generate predictive growth models, the percentiles from 3 to 97 will be calculated, using the LMS method and a q-q graph.

NCT ID: NCT03276884 Completed - Growth Clinical Trials

Growth and Tolerance of Young Infants

Start date: October 11, 2017
Phase: N/A
Study type: Interventional

To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.

NCT ID: NCT03276663 Completed - Growth Clinical Trials

Growth of Healthy Term Infants Fed a Partially Hydrolyzed Follow-up Formula

Start date: September 18, 2017
Phase: N/A
Study type: Interventional

Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of an existing partially hydrolyzed starter formula, then subsequently fed a partially hydrolyzed follow-up formula over the first year of life.