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Breast Feeding, Exclusive clinical trials

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NCT ID: NCT05109988 Recruiting - Parents Clinical Trials

Father-involvement Telephone Support Intervention on Breastfeeding: RCT

Start date: April 18, 2022
Phase: N/A
Study type: Interventional

The World Health Organization advocates for breastfeeding as the best source of food for optimal infant development, which reduces the risk of infant mortality and morbidity. The objectives of this study are to evaluate the effect of a father-involvement breastfeeding telephone support intervention on prevalence and duration of exclusive breastfeeding, postnatal depression and parent-infant bonding. The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers. We expect that women who receive the intervention will have a higher rate and longer duration of exclusive breastfeeding, fewer depressive symptoms and better parent-child relationship. The knowledge gained from this study can provide direction for the development of flexible, accessible and culturally sensitive interventions to promote breastfeeding and mental health in Chinese society.

NCT ID: NCT05051787 Completed - Clinical trials for Breast Feeding, Exclusive

Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach (CONCEPTION-AMOX)

CONCEPTION
Start date: June 23, 2022
Phase: Phase 4
Study type: Interventional

Based on plasma and milk concentrations, a PopPK model will be performed (i) to document the average and individual exposure to amoxicillin in milk, (ii) to identify the factors explaining the inter-individual pharmacokinetic variability and (iii) to determine the daily dose ingested by the infant and its variability for different dosage regimens applied to the mother. The secondary objectives are to monitor (i) predefined adverse reactions in infants and (ii) the impact on milk production.

NCT ID: NCT04954807 Completed - Clinical trials for Breast Feeding, Exclusive

Indonesia After Discharge LBW Infant HMF Supplementation Study

DAHLIA
Start date: December 8, 2020
Phase: N/A
Study type: Interventional

Low birth weight (LBW) infant (1800-2449 gram) will be given the new human milk fortifier (HMF) which contains protein, lipid, carbohydrate and micronutrients after discharge. Human Milk Fortifier or placebo (carbohydrate only with similar calorie content) will be provided until 3 months of age. The investigators want to evaluate if the addition of HMF to mother's milk while breastfeeding LBW infants after discharge influences growth and body composition up to 3 months of age.

NCT ID: NCT04769700 Completed - Covid19 Clinical Trials

Post-partum Depression, Breastfeeding Adherence and Fear in COVID-19

Start date: January 1, 2021
Phase:
Study type: Observational

This study aims to explore whether quarantine measures, social distancing and hospital containment policies among women giving birth during the COVID-19 pandemic enhanced psycho-emotional distress in the immediate postpartum period. The investigators tested for depression using the Edinburgh Postnatal Depression Scale (EPDS) in the first 6 postpartum months, and then used the Fear of COVID-19 Scale, measuring also the adherence and practices of breastfeeding according to WHO.

NCT ID: NCT04729166 Completed - Clinical trials for Breast Feeding, Exclusive

The Management of Perceived Breastmilk Insufficiency

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

A randomized control trial was made to determine the effectiveness of structured education and follow-up in the management of perceived milk insufficiency among breastfeeding mothers.

NCT ID: NCT04638075 Withdrawn - Clinical trials for Breast Feeding, Exclusive

Supplemental Nursing System Compared to Bottle Supplementation

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This is a randomized controlled trial comparing the SNS to bottle feeding. This study will compare exclusive breastfeeding rates and breast milk feeding rates at discharge, day of life 14, and day of life 28 between neonates hospitalized in the NICU for hyperbilirubinemia between those who receive supplementation by the (SNS) or those who receive supplementation by bottle. Additionally, this study will evaluate mothers' experiences while using the SNS. We hypothesize mothers who utilize the SNS will have higher rates of breast milk feeding compared to mothers who supplement by bottle.

NCT ID: NCT04135612 Completed - Clinical trials for Post Partum Depression

The Impact of a Daily Smartphone-based Communication Among Postpartum Women on Breastfeeding Rates

Start date: October 30, 2019
Phase: N/A
Study type: Interventional

We will aim to study the impact of introducing a smartphone-based daily feedback and communication platform between postpartum women delivering at our institute and a multidisciplinary breastfeeding-support team (obstetricians, neonatologists, midwives, lactation consultants, nurses, and psychologist) on breastfeeding rates.

NCT ID: NCT03903146 Completed - Clinical trials for Breast Feeding, Exclusive

Childhood Risk Reduction Program in Hispanics

ECOR-H
Start date: March 10, 2016
Phase: N/A
Study type: Interventional

Childhood obesity is a serious problem in the United States, as it increases the risk for various cardiometabolic, pulmonary, and psychosocial complications for children, which often continue into adulthood. Examination of disparities in early childhood obesity among ethnic groups shows that Hispanic infants/children have higher rates of overweight and obesity than children/infants of other races/ethnicities. According to the most recent National Health and Nutrition Examination Survey (2014), the prevalence of high weight for recumbent length (≥95th percentile) among infant and toddlers from birth to 2 years was 6.6% in Whites, 8.4% in Blacks, and 9.4% in Hispanics. Furthermore, the percentages of children ages 2 through 5 years who are overweight or obese (Body Mass Index [BMI] ≥ 85th) were 20.9% among non-Hispanic Whites, 21.9% among non-Hispanic Blacks, and 29.8% among Hispanics. These data suggest that ethnic disparities in childhood obesity prevalence have their origins in the earliest stages of life. Bergmann et al. reported that infants that received early formula artificial feeding by 3 months had significantly higher BMIs and thicker skin fold than exclusively breastfed infants, and from 6 months on, compared with breastfed children, a consistently higher proportion of artificially-fed children exceeded the 90th and 97th percentile of BMI and skin folder thickness reference values. Exclusive breastfeeding (EBF), defined as exclusive infant feeding with breast milk without any additional food or drink, is the feeding option engendering greatest nutrition and health, imparting enhanced glucose management and reductions in early childhood obesity. Hispanic mothers in the U.S. are more likely to supplement with formula in the first 2 days of life, compared with Black and White U.S. mothers (Hispanic 33%; Black 28%; White 22%). Additionally, a common feeding practice among Hispanic mothers is the early introduction of solids including ethnic food. The introduction of formula or complementary food in breastfed Hispanic infants produces an overfeeding problem that leads to childhood obesity. In a study published by this team of investigators on infant feeding management in Hispanic women living in Kentucky was reported that even when 51% of the group of Hispanic mothers initiated EBF during hospital stay, only 22% continued EBF at 4 months after birth. These trends underscore the critical need for intervention to support EBF in this population. Objectives: There is great opportunity and immense need to empower vulnerable, at-risk Hispanic mother/infant dyads to prevent and manage childhood obesity by increasing duration and EBF and delaying the introduction of complementary food. The primary aim of this pilot study was to determinate the feasibility and evaluate the clinical impact of a novel, tailored, culturally and linguistically appropriate community-based intervention. The intervention was delivered by Hispanics bilingual/bicultural team of an International Board Certified Lactation Consultant (IBCLC) and a peer counselor (PC) and was tested in terms of its influence on key modifiable factors that are positively associated with increasing breastfeeding duration and exclusivity: (a) mother's breastfeeding intention; (b) breastfeeding self-efficacy; and (c) perceived social support. Specific aims for this study are: Aim 1: Determine the feasibility of the intervention. This aim is designed to answer the following important research questions: Q-1: Is the planned recruitment period sufficient to enroll the targeted number of participants? Q-2: What percent of treatment group participants will complete all sessions of the intervention? Q-3: What percent of participants will be retained in the study until the conclusion? Q-4: What factors are associated with intervention adherence and study retention? Aim 2: Evaluate the clinical impact of the intervention. The following hypotheses will be tested: Hypothesis #1: Women in the intervention group will have higher intention to breastfeed during the pre-natal period and will perceive greater self-efficacy and social support during postnatal period, compared with the usual care group. Hypothesis #2: Women in the intervention group will be more likely to initiate EBF during their post-delivery in-hospital stay than those in the usual care group. Hypothesis #3: Among those who practice EBF during their hospital stay, women in the intervention group will be more likely to continue EBF for six months than women in the usual care group. Hypothesis #4: Women in the intervention group will have longer time to introduction of complementary food to their infants compared with the usual care group.

NCT ID: NCT02435524 Completed - Breast Feeding Clinical Trials

Alive & Thrive Evaluation in Burkina Faso

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

The time between birth and age 24 months provides a unique opportunity to impact the long-term health and development of children through improved infant and young child feeding practices. In Burkina Faso, the prevalence of exclusive breastfeeding is currently around 25% in infants younger than six months. The purpose of this study is to evaluate whether the Alive & Thrive intervention package, consisting of interpersonal counselling and community mobilisation activities, can increase the exclusive breastfeeding rate among infants younger than six months to at least 50% using a cluster randomised design.

NCT ID: NCT01890668 Completed - Clinical trials for Breast Feeding, Exclusive

Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour

NEOSTEO
Start date: July 2013
Phase: N/A
Study type: Interventional

Breastfeeding is one of the prime factors of long-term health protection in newborns, for nutritional, immunological and developmental reasons. In France there is a wide inter-regional variability of breastfeeding rates at discharge. This variability associates different factors involving both, mothers, birth conditions, newborns and mother-child couple. Some approaches, including osteopathy, aim to support early breastfeeding difficulties. As many others non-conventional medicines, there is a huge and growing interest for this alternative therapy and a spontaneous recourse in the first months of life. Nevertheless, neither efficacy nor the benefits have been studied. Thus, our objective is to evaluate for the first time in France, in a randomized, double-blinded design, the efficacy of early osteopathic manipulative treatment (OMT), in suboptimal breastfeeding behaviour healthy newborns. 128 couples mother-child will be randomized in two groups: with or without osteopathic intervention on the newborn.