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Infant clinical trials

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NCT ID: NCT03406221 Completed - Pregnancy Clinical Trials

Use of Mobile Technology by Community-Based Health Workers to Promote Maternal and Child Health in Bihar, India

ICT-CCS
Start date: January 1, 2012
Phase: N/A
Study type: Interventional

This study is designed to evaluate the impact of use of mobile technology by community-based health workers on health-promoting behaviors among women related to reproductive, maternal, newborn and child health and nutrition in Bihar, India. The intervention was funded by the Bill and Melinda Gates Foundation (BMGF) and in collaboration with CARE was implemented from 2012 to 2014. Health sub-centers in the catchment areas of four blocks (sub-districts) of the district of Saharsa were randomly assigned to treatment or control arms (35 sub-centers were assigned to each). Data were collected in the Intervention and Control areas from mothers of infants 0-12 months at baseline and at 2-year follow-up, to assess the intervention's effects on quality and quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers, complementary feeding and vaccination. Difference in difference analyses were used to assess outcome effects in this quasi experimental study. The ICT-CCS intervention was implemented in areas where the BMGF-funded Ananya program (official title: Bihar Family Health Initiative) was also being implemented. Thus, the impact is of the [ICT-CCS intervention + Ananya] versus [Ananya alone]. The Ananya program was developed and implemented via a partnership of BMGF, CARE, and the Government of Bihar. The ultimate purpose of Ananya was to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health facilities and quality of care to improve maternal and neonatal care and health behaviors, and thus survival. It was implemented from 2012 to 2014. Eight focal districts in western and central Bihar received Ananya, while 30 districts did not.

NCT ID: NCT03025178 Completed - Infant Clinical Trials

Optimal Insertion Depth of Left Internal Jugular Vein Catheter in Infants

Start date: March 8, 2017
Phase: N/A
Study type: Interventional

We previously performed a study to create formula for the optimal insertion depth of left internal jugular vein catheter in infant, which was registered at cris.nih.go.kr. We found that two calculation methods using height and the distance between landmarks (0.11 × height (cm) + 0.19 and 1.02 × I-A-B (cm) + 1.55, where I was insertion point of needle, A was the most prominent point of the sternal head of the left clavicle, and B was the midpoint of the perpendicular line drawn between the sternal head of the right clavicle and an imaginary line between the nipples) were clinically feasible to determine the insertion depth of left internal jugular vein catheter. In this study, we will compare the actual insertion depth with the insertion depth determined from above two calculation methods in other 46 infants.

NCT ID: NCT02722759 Completed - Infant Clinical Trials

Haemoglobin Measurement for Babies

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

In this prospective study different methods of haemoglobin measurement in term and preterm neonates are compared with the gold standard. Non-invasive haemoglobin measurement with the Radical-7® (SpHb, Masimo®), point-of-care haemoglobin-measurement (HcHb, HemoCue@, Radiometer), blood-gas-analysis (BGAHb,ABL800®, Radiometer) are compared with haemoglobin measurement by an automated hematology analyzer (labHb, Siemens Advia®).

NCT ID: NCT02580123 Completed - Health Promotion Clinical Trials

Smile-Kids: Study on Complementary Feeding Transition

Start date: May 2012
Phase: N/A
Study type: Interventional

The importance of families in the development of infants is well documented. Previous studies found that the prevalence of overweight and obesity is growing concerns in Portugal (Padez, Fernandes, Mourão, Moreira, & Rosado, 2004) and in the world (Ogden et al., 2014). More, there is evidence that habits acquired in early life might track into adulthood (Lien, Lytle, & Klepp, 2001; Lytle, Seifert, Greenstein, & McGovern, 2000; te Velde, Twisk, & Brug, 2007). Therefore, there is a need to lock overweight and obesity in early childhood in order to contribute to health gains during the entire life cycle. The main purpose of this research is to evaluate the impact of an intervention program based on parenting skills and feeding practices, on infant's growth, development and adherence to new foods in early infancy Methods: 58 infants, 4-12 months from 25 nursery schools participated in this randomized trial and were randomly allocated to intervention and control group. Infant outcomes were performed at baseline and post-intervention and included anthropometry, dietary assessment and temperament. In addition maternal and family outcomes such as anxiety, dietary intake were also assessed at both times. An intervention program was developed and Implemented according to two terms: educators' training with the researchers and the intervention with parents and infants developed by trained educators. The training program was developed between December 2013 and February 2014, according to the topics of healthy eating and nutrition and development of the infant. The control group received the standard care. It is expected that this intervention program is able to promote healthy feeding practices to parents and nursery teachers. The results will be disseminated to the stakeholders and policymakers that work closely to the topic of this study. This will include papers' publication, participation in national and international meetings, contributing to the advance of research in this health area.

NCT ID: NCT02482012 Completed - Infant, Premature Clinical Trials

Minor Increase Over Minimal Risk Research in NICU

Start date: June 2014
Phase: N/A
Study type: Observational

Infants comprise a potentially vulnerable research population that received special consideration and protections under the US Code of Federal Regulations - Subpart D. Of the four categories of research involving children, 45 CFR 46.406 is of particular interest to researchers, ethicists, parents, and clinical staff members since it concerns the conduct of research with "more than minimal risk" without the prospect of direct benefit. Parents are the surrogate decision makers for infants. When asked about this type of research in studies pertaining to older infants and children, parent themes include: concerns of medical research and research-related risk, desire to advance generalizable medical knowledge and knowledge specific to their own child's disease. There are no data on parents' perceptions regarding this category of research that target the premature, late-preterm and term newborn populations. This study involves a questionnaire for both staff (nurses and physicians) and parents. The questionnaire represented 4 different infant scenarios in a random order. Respondents are asked to answer questions related to enrollment in a research study for each of the 4 scenarios.

NCT ID: NCT02441296 Completed - Metabolism Clinical Trials

Carbohydrate and Metabolism: a Pilot Study

Start date: October 2013
Phase: N/A
Study type: Interventional

The optimal choice of carbohydrate in infant formula needs to be assessed in more detail. Lactose has conventionally been used in most milk-based infant formulas, but more recently lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity. However, the metabolic consequences have not been examined. In a pilot study, the investigators will assess the postprandial metabolic response to a meal of formula with either lactose or maltodextrins. A breastfed reference group is also included.

NCT ID: NCT02366780 Completed - Infant Clinical Trials

Breast Milk Content Expressed Manually Compared to Electric Pump

Start date: November 2012
Phase: N/A
Study type: Interventional

Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive factors for the health and development of infants.Colostrum, which is produced in low quantities for the first 3 to 4 days after birth, is rich in immunologic components and developmental factors. Breastfeeding difficulties during the first days of life of an infant are common. Moreover, not all infants can be directly fed at the breast. Therefore, breast milk feeding at this early stage is initiated and promoted by the expression of breast milk either manually or by use of a pump. Whether the method of milk expression at this stage has a qualitative impact on colostrum is currently unknown. The purpose of this randomized controlled study is to compare the effect of manual expression with electric pump expression upon the macronutrient composition of breast milk.

NCT ID: NCT01573871 Completed - Infant Clinical Trials

Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

Start date: February 2012
Phase: Phase 3
Study type: Interventional

The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.

NCT ID: NCT01216709 Completed - Infant Clinical Trials

Iron Absorption From Infant Formula and Iron Drops in Infants (MJAU-studien)

MJAU
Start date: October 2010
Phase: N/A
Study type: Interventional

Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant foods are recommended for infants. However, the optimal iron dose and mode of delivery have not yet been established. This is a concern as excessive iron intake may impair growth and increase morbidity in iron-sufficient infants. Previous studies have suggested that iron-fortified foods may have different effects than iron supplements. In this study, the investigators will investigate whether the mode of iron administration (supplementation vs. fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption, iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.

NCT ID: NCT01167270 Completed - Obesity Clinical Trials

The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study

INSIGHT
Start date: January 2012
Phase: N/A
Study type: Interventional

This study will test an intervention program designed to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle to see if that intervention will prevent rapid weight gain in infancy and overweight at age 3 years. Further, compared with control infants, intervention infants will have lower body mass index (BMI) percentiles at age 3. The investigators also hypothesize that control infants will gain weight more rapidly over time.