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Infants clinical trials

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NCT ID: NCT06447558 Completed - Infants Clinical Trials

The Effects of "Oral Administration of Breast Milk Droplets" and "Palatal Stimulation With a Finger"

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the effects of "oral administration of breast milk droplets" and "finger palatal stimulation" on feeding tolerance in preterm neonates fed with orogastric tube feeding. This randomized controlled experimental study was conducted in the neonatal intensive care unit of a private hospital. The study included 90 premature newborns born at 28-36 weeks of gestation and admitted to the intensive care unit. The intervention group consisted of 60 infants and the control group consisted of 30 infants. "Demographic Information Form" and "Patient Follow-up Form" were used to collect data. Data collection tools were used before, during and after the procedures in all groups. In one of the intervention groups, breast milk droplets were applied to the oral cavity of the newborns, and in the other group, the palate of the newborns was stimulated using a finger. These interventions were performed for 5 minutes every 3 hours for 7 days during the newborns' feeding times. Neonates in the control group were fed with an orogastric tube by following hygiene rules, but no study intervention was performed in these infants. SPSS (Statistical Package for Social Sciences) 22.0 for Windows software was used for statistical analysis.

NCT ID: NCT06353841 Recruiting - Constipation Clinical Trials

Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children

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

The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children.

NCT ID: NCT06319079 Not yet recruiting - Infants Clinical Trials

Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition

Start date: March 2024
Phase: N/A
Study type: Interventional

Vulnerable populations, who have deficient diets, may produce human milk (HML) that is not adequate in all nutrients and this will have consequences on the growth and development of the child. In 2021 at IDIP, a specific milk product for pregnant and lactating women Super Mil Mamá ( SMM, whole milk powder fortified with multiple vitamins, minerals and DHA ) has been designed and developed as part of a key strategy to incorporate in public policies for the first 1000 days of life. However, the potential benefits of this product have not yet been evaluated at the population level. The main objective is to evaluate the effect of the consumption of a milk product (SMM) designed for lactating women on the composition of human milk and the nutritional status of iron and DHA in infant red blood cells in a vulnerable population through a randomized, triple-blind, controlled clinical trial. Specific objectives To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc and Calcium in human milk before and after dietary supplementation with SMM. To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron before and after dietary supplementation with SMM. To analyze the relationship between micronutrients measured in maternal blood and human milk after dietary supplementation with SMM. To compare the concentrations of micronutrients measured in blood and human milk in women who received SMM and those who received commercial milk (CM) at the end of supplementation. To compare the iron nutritional status and DHA content in red blood cells of infants of mothers who consumed SMM or LC. To evaluate the relationship between the concentration of micronutrients in human milk and infant growth during the first six months of life.

NCT ID: NCT06318858 Recruiting - Anemia Clinical Trials

Daily and Weekly Iron Supplementation in Infants

Start date: March 15, 2023
Phase: N/A
Study type: Interventional

This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Infants will be enrolled at 6 months and will be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months and will be followed by weekly iron supplementation for another 3 months.

NCT ID: NCT06127914 Not yet recruiting - Infants Clinical Trials

Learning Early Infant Feeding Cues

LEIFc
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn more about responsive infant feeding (recognizing baby's signs of hunger and fullness) in mothers and infant enrolled in government-funded maternal-child home visiting programs. The main questions it aims to answer are: - What are the contributors and barriers to use of responsive infant feeding? - How can we refine an intervention focused on responsive infant feeding (the Learning Early Infant Feeding Cues intervention) so that mothers will like it and learn skills to help their baby be healthy. - Will the refined intervention improve use of responsive feeding and be feasible and acceptable to mothers and home visiting programs? Participants will be asked to: - Participate in focus groups to talk about their experiences feeding their baby. - Participate in a study to learn about responsive feeding and how to use it with their baby. This study will start when mothers are in their final month of pregnancy and finish when their baby is 6 months old. Participation will include: - Having someone come to the family home during a time when the baby is eating (either from the breast or the bottle). The mother will receive information on the baby's signs from an experienced coach. - Agreeing to be video recording during the session when the baby is eating. - Completing surveys online.

NCT ID: NCT05994417 Not yet recruiting - Infants Clinical Trials

Beyond Race: Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants

Start date: August 15, 2023
Phase:
Study type: Observational

The overall objective of this proposal is to quantify the bias in pulse oximeter reported oxygen saturation (SpO2) by evaluating its measures compared to the gold standard blood gas measured arterial oxygen saturation (SaO2) across race and skin pigmentation. The main question that the investigators intend to answer is whether 1. There is greater pulse oximeter bias and subclinical hypoxemia in (1a) Black compared to White infants, and (1b) dark versus light-pigmented infants 2. This bias increases with gestational and postnatal maturation 3. This bias is associated with adverse patient outcomes

NCT ID: NCT05940688 Recruiting - Pregnancy Clinical Trials

Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study

P?OPPY
Start date: July 17, 2023
Phase: N/A
Study type: Interventional

The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes.

NCT ID: NCT05705258 Recruiting - Clinical trials for Retinopathy of Prematurity

A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity)

Start date: March 27, 2023
Phase:
Study type: Observational

This is an observational study to collect data from Japanese babies with retinopathy of prematurity (ROP) who will be treated with Eylea. In observational studies, only observations are made without specified advice or interventions. ROP is a condition that affects the eye and occurs only in babies who are born too early. Most cases of ROP are mild and get better without treatment, but more serious cases need to be treated in time. ROP happens when the blood vessels in the "retina" grow abnormally. The retina is the layer of tissue at the back of the eye that picks up light and sends messages to the brain. In babies with ROP, these abnormal blood vessels can leak. This causes damage to the retina and can sometimes move it out of place causing medical problems such as blindness. Eylea is received as an injection into the eye. It works by blocking a certain protein (VEGF) that can cause blood vessels in the retina to grow abnormally. Eylea is already available in Japan and is approved for doctors to prescribe to babies with ROP. The participants in this study are Japanese babies with ROP that their doctors decided to treat with Eylea before the start of this study. Babies with ROP that were already prescribed Eylea by their doctors may also be included. The main purpose of this study is to collect more data on how safe the treatment with Eylea is in babies with ROP under a real-world setting. Another purpose of this study is to collect more data on how well Eylea works in these participants. To see how safe Eylea is, the study doctors will collect all medical problems that the participants treated with Eylea have. These medical problems are called adverse events. Doctors keep track of all the adverse events that happen, even if they do not think that they might be related to the treatment. To see how well Eylea works, the study doctors will check the number of participants: - with no active ROP after starting treatment - where ROP came back up to 6 months after start of treatment In this study, the study doctor will: - collect past data of the participants from medical records - interview the participants - collect treatment-related data during routine visits. The study duration is 6 months with 3 planned visits. One visit will be at start of treatment, one at one month and one at 6 months after start of treatment. All data required for this study will be collected during routine visits. Besides this data collection, no further tests or examinations are planned in this study.

NCT ID: NCT05492253 Completed - Clinical trials for Healthy Participants

First Complementary Foods and the Infant Gastrointestinal Microbiota

Start date: January 30, 2023
Phase: N/A
Study type: Interventional

This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.

NCT ID: NCT05266677 Withdrawn - Infants Clinical Trials

DHA Proof-of-Concept Study in Infants and Toddlers

DHA
Start date: July 2022
Phase: N/A
Study type: Interventional

This is a prospective, double blind, randomized, controlled proof-of-concept study with a parallel group design that aims to investigate the effect of a liquid oral supplement comprising a blend of glycerides at certain proportions on infant and toddler DHA status.