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Infant Nutrition clinical trials

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NCT ID: NCT05310396 Recruiting - Infant Nutrition Clinical Trials

Efficacy of a Nutrient Blend in Improving Neurocognitive and Behavioral Outcomes in Infants: a Randomized, Controlled, Intervention Study

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

The purpose of this study is to demonstrate the efficacy of the nutrient blend in a starter infant formula (IF) and follow up infant formula (FUF) in improving the neurocognitive and behavioural outcomes among formula-fed infants randomized to the experimental formula (EF) versus the control formula (CF).

NCT ID: NCT05119166 Recruiting - Maternal Health Clinical Trials

International Milk Composition (IMiC) Consortium

IMiC
Start date: November 17, 2019
Phase:
Study type: Observational

The IMiC Consortium will analyze milk from 1000 mother-infant dyads across 4 diverse settings (Tanzania, Pakistan, Burkina Faso and Canada). Samples will be stored centrally at the Manitoba Interdisciplinary Lactation Centre (MILC) biorepository and distributed to multiple laboratories for analysis of macronutrients, micronutrients, oligosaccharides, growth factors, immunoglobulins, cytokines, metabolites and microbes. Data will be harmonized and stored in a central database, and diverse statistical methods will be applied for data integration and analysis.

NCT ID: NCT04803981 Recruiting - Infant Nutrition Clinical Trials

Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

INTENT
Start date: April 9, 2021
Phase: N/A
Study type: Interventional

This is a randomized, controlled, open-label, pragmatic, direct-to-participant trial designed for infants. The study will be conducted using a mobile application platform to engage parents with healthy infants and parents with infants with eczema in introducing complementary feeding in line with new feeding guidelines for diet diversity, gather parental experiences of feeding, support early introduction of different food proteins and support feeding of SpoonfulONE.

NCT ID: NCT03589963 Terminated - Breastfeeding Clinical Trials

Providing Postnatal Breastfeeding Support Through the Canada Prenatal Nutrition Program

PINSTEP-4
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

The Canada Prenatal Nutrition Program (CPNP) aims to improve birth outcomes among Canadian women in challenging life circumstances, including those who are adolescents, newcomers, low-income or single mothers. The CPNP strongly promotes breastfeeding prenatally, resulting in high initiation rates, but continued postnatal support is needed to optimize breastfeeding duration and exclusivity. The aim of this research is to investigate the effects of adding postnatal lactation support as an extension to the CPNP on breastfeeding duration and exclusivity in the first six months postpartum. The research will be conducted at two CPNP sites in Toronto, Parkdale Queen West Community Health Centre and The Stop Community Food Centre. A quasi-experimental design will be used to compare the infant feeding practices of CPNP clients before and after introduction of a postnatal lactation support intervention which will include in-home professional lactation support and provision of high-quality breast pumps. These services will be delivered as CPNP program components and will be accessible to all clients at the two participating sites during the post-intervention period. Infant feeding practices will be assessed by a questionnaire administered at 2 weeks, 1, 2, 3, 4, 5 and 6 months postpartum. The hypothesis is that significantly more mothers in the post-intervention group will be exclusively breastfeeding at four months postpartum. The effect is expected to be mediated through increased breastfeeding self-efficacy, which will be assessed using validated scales prenatally and at 2 weeks and 2 months postpartum.

NCT ID: NCT03513744 Completed - Infant Nutrition Clinical Trials

Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

Start date: November 19, 2018
Phase: N/A
Study type: Interventional

The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.

NCT ID: NCT03400605 Completed - Breastfeeding Clinical Trials

Parkdale Infant Nutrition Security Targeted Evaluation Project: Infant Feeding

PINSTEP-3
Start date: August 17, 2017
Phase:
Study type: Observational

In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides weekly pre- and post-natal support and education programs for clients. This includes an infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has a diverse client-base; the program is aimed at women who are in challenging life circumstances, therefore, clients may include low-income or single mothers and newcomers to Canada. The aim of this project is to investigate the incidence, duration and exclusivity of breastfeeding and timely complementary feeding based on level of maternal participation in components of a pre and postnatal community outreach program. Exploring infant feeding practices is an evaluation component that will not only characterize infant feeding practices within a vulnerable population, but will elucidate whether there are areas of concern that need to be expanded upon within pre or postnatal programming. A prospective infant feeding questionnaire will be administered to participants at 2 weeks and at 2, 4 and 6 months postpartum. The study population will consist of women who enrolled in 5P's prenatally. The hypothesis is that exclusive breastfeeding rates will be low, but higher breastfeeding rates will be observed among women who utilize provided postnatal services more readily.

NCT ID: NCT03305406 Completed - Breastfeeding Clinical Trials

Parkdale Infant Nutrition Security Targeted Evaluation Project: Focus Groups & Interviews

PINSTEP-2
Start date: August 18, 2017
Phase:
Study type: Observational

In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides weekly pre- and post-natal support and education programs for clients. This includes an infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has a diverse client-base; the program is aimed at women who are in challenging life circumstances, therefore, clients may include low-income or single mothers and newcomers to Canada. The overall goal of this research is to optimize the existing 5P's program. Program acceptability is an essential component of the process evaluation to understand the experiences of mothers and the perceived supports and barriers of the program. Specifically, the aim of this project is twofold: 1) to investigate the perceptions and experiences of accessibility of a postnatal community program and 2) to explore the perceptions of, and attitudes toward, a community infant feeding program offering lactation consultant and breast pump resources. This study will use a qualitative approach by way of semi-structured focus groups and interviews. The study population will consist of women who enrolled in 5P's prenatally and have delivered their infant. This will include women who did and did not continue to participate in the postnatal program and/or Feeding Tiny Souls after delivery. The investigators will specifically seek women who participated in the prenatal program, but did not take part in the postnatal program and/or Feeding Tiny Souls to understand why participants did not access these resources and gather information on their views of these postnatal program components. The hypothesis is that the postnatal community program is a source of support for clients, but that it needs to be expanded to include more clients and the infant feeding program is an important support for helping clients to provide breast milk to their infant.

NCT ID: NCT03278847 Completed - Clinical trials for Necrotizing Enterocolitis

Optimising Newborn Nutrition During Therapeutic Hypothermia.

Start date: January 1, 2010
Phase:
Study type: Observational

The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia. To do this the investigators will perform two primary comparisons: 1. ENTERAL: to determine whether any enteral (milk) feeding, when compared to withholding enteral feeding (no milk), during therapeutic hypothermia, is associated with a difference in the incidence of necrotising enterocolitis. 2. PARENTERAL: to determine whether provision of intravenous dextrose, when compared to provision of parenteral nutrition, during therapeutic hypothermia, is associated with a difference in the incidence of blood stream infection. The investigators will use de-identified data held in an established research database called the National Neonatal Research Database (NNRD) and we will use the potential outcomes framework with application of propensity scoring to define matched subgroups for comparison.

NCT ID: NCT03204630 Completed - Infant Nutrition Clinical Trials

Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk

Start date: January 2011
Phase: N/A
Study type: Interventional

A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota

NCT ID: NCT02626143 Completed - Infant Nutrition Clinical Trials

Effect of Feeding Mode on Infant Growth and Cognitive Function

Start date: February 2016
Phase: N/A
Study type: Interventional

This study is intended to compare growth, nutritional status, and brain development in children fed an Investigational cow's milk based formula containing a nutrient-rich whey protein, a standard cow's milk based formula, or fed exclusively breast milk.