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Infant Development clinical trials

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NCT ID: NCT05945017 Active, not recruiting - Infant Development Clinical Trials

Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32 weeks' gestation and a birthweight under 1,500 g. This probiotic combination has shown to be safe and beneficial in premature neonates in the prevention of NEC. The investigators hypothesised that this mixture would contribute to better neurodevelopmental outcomes of preterm neonates when assessed at 24 months corrected age. Additionally, neurodevelopment improved would be more relevant at 6 years of age, together with a better pattern of neuronal plasticity biomarkers. Secondarily, this mixture of probiotics could reduce NEC, LOS, intraventricular haemorrhage and neonatal mortality in accordance with previous studies.

NCT ID: NCT05695300 Active, not recruiting - Infant Development Clinical Trials

Gut Health,Feces Characteristics and Growth of Infants Fed With a New Infant Organic Formula

Start date: February 3, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evauate the gut health, feces characteristics and growth of infants fed with a new study organic formula (investigational formula). 75 eligible infants of 30 days old will be enrolled at one center and randomized to feed the investigational formula, control formula, and breast milk for 3 months. Researchers will compare the three groups to evaluate the gut health, feces characteristics and growth of infants by the end of the study.

NCT ID: NCT05491161 Active, not recruiting - Diet, Healthy Clinical Trials

The Motility Mother-Child Cohort

MOTILITY
Start date: August 22, 2022
Phase:
Study type: Observational

The overall aim of the project is to investigate how bowel habits and nutrition in early life relate to the infant gut microbiome and metabolome from birth to 1 year of age. By unravelling links between these factors in early life, we might be able to identify new putative mechanisms by which diet via microbiota-dependent pathways affects intestinal motility in early life. Furtermore, it will be explored how the development of the gut microbiome associates with the child´s development.

NCT ID: NCT05363553 Active, not recruiting - Infant Development Clinical Trials

Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study

TIGER
Start date: May 25, 2022
Phase: N/A
Study type: Interventional

To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from breastfeeding to formula feeding, using predominantly breastfed infants as a reference group.

NCT ID: NCT05343403 Active, not recruiting - Premature Birth Clinical Trials

Parental Participation on the Neonatal Ward - the neoPARTNER Study

neoPARTNER
Start date: March 7, 2022
Phase:
Study type: Observational

Objective: To investigate the effect of FCR as part of the FICare principles during hospital stay, on parental stress at discharge in parents of preterm or ill infants admitted to the neonatal ward for >7 days as compared to standard medical rounds (SMR) without parents as part of standard neonatal care (SNC).

NCT ID: NCT05259423 Active, not recruiting - Infant Development Clinical Trials

The Effects on Children and Parents of Educating Parents About Ways to Play With Babies

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

The purpose of this study is to determine whether educating parents about how to play with infants affects infant development or caregiver characteristics. The project will comparatively evaluate the effects of two different play education programs on infants' development and on caregiver characteristics in a sample of infants with typical development and a sample of infants with/at risk for developmental delay.

NCT ID: NCT05106894 Active, not recruiting - Infant Development Clinical Trials

Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Start date: January 11, 2023
Phase: N/A
Study type: Interventional

Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority. Supporting caregivers to provide nurturing care is an evidence-based strategy, however feasibility of scaling-up this supporting is limited by competing demands on health workers' time. For infant development, mHealth technologies have the potential to solve this problem by providing tailored content directly to caregivers, involving and empowering them to promote infant development, promoting and facilitating interactions with health workers when areas of concern are identified and, therefore, expanding the reach of healthcare systems. This overall study is designed to explore this idea, by designing a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala in providing nurturing care and, after design, to conduct a prospective implementation trial of its use followed by an adequately-powered efficacy study.

NCT ID: NCT04826978 Active, not recruiting - Preterm Birth Clinical Trials

Auditory Environment by Parents of Preterm Infants

APPLE
Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

Data on parent-infant physical closeness and infants' auditory environment will be collected among preterm infants when they are at gestational age of 32 to 34 weeks. The follow-up includes eye-tracker test at 7 months of corrected age for face preferences of the infants and simultaneously parents' eye movements and pupil diameter responses. During the second year, the follow up includes MacArthur Communicative Development Inventories (lexical development) at 12 and 24 months of age; language development test (Reynell Developmental Language Scales III) and developmental test (Bayley Scales for Infant development Edition III) at 24 months of corrected age.

NCT ID: NCT04807907 Active, not recruiting - Infant Development Clinical Trials

Promoting Infant-Directed Speech in Ghana

Start date: March 2, 2021
Phase: N/A
Study type: Interventional

The study is a randomized evaluation of a low-cost intervention that encourages mothers and other caregivers to talk to infants, or to engage in what is known as infant-directed speech (IDS) as a way of promoting language and brain development in Tamale and surrounding areas, Ghana.

NCT ID: NCT04749888 Active, not recruiting - Pregnancy Related Clinical Trials

Impact of the Korea Early Childhood Home-visiting Intervention

KECHI
Start date: October 27, 2021
Phase: N/A
Study type: Interventional

Maternal and early childhood home visits have been proposed as an effective strategy to improve the health and development of disadvantaged children. In South Korea (hereafter, Korea), a maternal and early childhood home visit program has been implemented since 2013 in Seoul, and then was adopted in 2019 by the central government as a national policy for child health and development. The Korea Early Childhood Home-visiting Intervention (KECHI) encompasses 25-29 home visits, group activities, and community service linkage by social workers from the prenatal period until the child reaches the age of 2 years; as such, it is a complex intervention involving various domains to address a wide range of outcomes. Each home visit is implemented based on the family's needs, and individualized interventions are provided to improve parenting and the home environment in order to promote children's health and development and maternal health. This study is a randomized controlled community trial conducted in Korea to examine the impact of targeted home visits led by nurses in the prenatal and early childhood period on children's health and development and maternal health. This study is a superiority trial with two parallel groups from pregnancy until the child reaches 2 years of age. Pregnant women with two or more risk factors will be recruited to participate in the study after they provide informed consent. Participants will then be randomly assigned to the intervention or control group with a 1:1 allocation through an independent web-based random allocation system. We expect a total of 800 families (400 families in each group) to be recruited. The intervention group will receive the KECHI program and the control group will receive existing maternal and child health services (usual care), but not multiple home visits by nurses. Both groups will receive gift cards of 30,000 Korean won (about 27 USD) for each round of surveys. The intervention and control groups will be surveyed on the outcome variables of home environment, child development, breastfeeding, maternal health, child hospital visits due to injuries, and community service linkage at four home visits by trained research nurses at baseline and at 6 months, 12 months, and 24 months after birth. Telephone contact will also be made at 6 weeks and 18 months after birth for both groups. Outcome measurements will be performed by research nurses and data management will be conducted by statistical analysts. The analysis will be conducted for the intention-to-treat (ITT) and per-protocol (PP) groups, with an interim analysis of outcomes up to the 6-month follow-up. For the primary outcomes and certain secondary outcomes, subgroup analyses will be performed based on factors such as region, fertility status, number of risk factors, presence of depression, education level, etc.