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Birth Weight clinical trials

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NCT ID: NCT05119868 Recruiting - Obesity Clinical Trials

Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring

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

Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.

NCT ID: NCT05108454 Recruiting - Clinical trials for Infant, Low Birth Weight

Multiple Micronutrient Supplementation (MMS) Evaluation Among Bangladeshi Pregnant Women

Start date: December 15, 2021
Phase:
Study type: Observational

Maternal nutrition profoundly affects foetal growth, development, and subsequent infant birth weight. Babies with low birth weight (LBW) have an elevated risk of death in infancy and later childhood. A recent systematic review revealed that multiple micronutrient supplementations (MMS) could reduce the risk of LBW by 13% in comparison with iron and folic acid (IFA). Based on this newer evidence, the World Health Organization (WHO) recommended MMS during a pregnancy instead of IFA, with consideration of the country context-specific research. However, little progress is being achieved in ensuring adequate MMS coverage to improve pregnancy outcomes. Based on the WHO recommendation, CIFF awarded the Social Marketing Company (SMC) to set up a sustainable business model with affordable and quality MMS to pregnant women in Bangladesh over a period of 5 years through SMC's pharmacy networks. The investigators propose to develop an evaluation design including both process and outcome evaluation to evaluate the implementation and effect of the MMS by the SMC in Bangladesh. The evaluation study will comprise both process and outcome evaluation, complementing each other. The design will be a quasi-experimental cluster-based open cohort, two-arm, mixed-methods design. The evaluation would take place in 5 divisions of Bangladesh.

NCT ID: NCT04845230 Recruiting - Premature Birth Clinical Trials

Fresh RX: NHS 2020

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

This study is an evaluation of the Fresh Rx: Nourishing Healthy Starts program administered by Operation Food Search, a St. Louis-based nonprofit organization. The program provides food and nutrition supports to food insecure pregnant women in conjunction with integrative care services in order to improve health and birth outcomes for both the mother and the child. The purpose of this study is to test the efficacy of this approach through a field experiment, and to assess the extent to which these services can provide cost savings to the healthcare system.

NCT ID: NCT04725734 Recruiting - Pregnancy Clinical Trials

Air Pollution and Daily Mobility of Pregnant Women Identification of Critical Windows of Exposure

MOBIFEM
Start date: February 4, 2021
Phase:
Study type: Observational

This study is conducted to assess the role of pregnant women's daily mobility living in the Eurometropole of Strasbourg in a context of the existence of environmental exposure disparities (PM10, PM2.5, NO2). Furthermore, this study will tend to identify the critical windows of exposure and of greater risk of the adverse pregnancy outcomes as low birth weight and prematurity. A second question addressed in this work is to assess the relationship between the pregnant women's socio-economic status and the air pollution exposure (PM10, PM2.5, NO2).taking into account the spatio-temporal variations of the exposure as well as the critical windows of exposure during pregnancy. The present work deals with the following question "how does the combination of environmental exposure, socio-economic status and women's daily mobility, could contribute to socio-spatial inequalities in the health of the newborn? The underlying hypothesis is that the accumulation, in given area, of environmental exposures (as PM10, PM2.5 and NO2), of unfavorable living conditions (socio-economic environment) and individual factors (specific spatio-temporal trajectory) would induce an increased risk for the health of the newborn, (more particularly in terms of birth weight and term of birth). This hypothesis is structured 4 sub-hypotheses: i) The misclassification of exposure is socially distributed among pregnant women living in the Eurometropole of Strasbourg. ii) Beyond maternal and fetal characteristics, pregnant women who reside in a more socio-economically deprived neighborhood and / or with higher levels of environmental exposure to PM10, PM2.5 and NO2 are more at risk of preterm newborn and low birth weight newborn. iii) The accumulation of environmental exposures of the pregnant women and their daily mobility over their territory during the pregnancy increase the health inequalities of the newborn. iv) The critical windows of fetal exposure to pollutants is related to the socioeconomic level of their neighborhood and to the daily mobility of the women in their territory during pregnancy. Women are included in the study at the time of their first or second trimester ultrasound. Here are the tools used in the study: Descriptive survey of their idividuals characteristics, descriptive survey of women's mobility to assess their exposure during each trimester of pregnancy.

NCT ID: NCT04694235 Recruiting - Child Development Clinical Trials

Egg Intervention During Pregnancy in Indonesia

PRECODE
Start date: February 12, 2021
Phase: N/A
Study type: Interventional

The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old

NCT ID: NCT04542096 Recruiting - Respiratory Failure Clinical Trials

Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT

Start date: September 29, 2020
Phase:
Study type: Observational

Electric Impedance Tomography (EIT) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a real time, radiation free, non-invasive and portable. Neonatal respiratory distress syndrome (RDS) is a respiratory disorder resulting from immaturity of the lung structure and lack of surfactant. It is one the most common conditions in premature infants. Many of these infants require either invasive or non-invasive respiratory support. The goal of the study is to investigate the dynamic changes in pulmonary aeration during assisted breathing in very low birthweight preterm infants using pulmonary electrical impedance tomography. Currently most widely used methods to assess respiratory lung function are either invasive and/or indirect (ABG, pulse oximetry, transcutaneous pCO2 measurement), lacks temporal resolution (lung ultrasound) or emit ionizing radiation (CT). EIT provides information on regional lung aeration without the aforementioned shortcomings.

NCT ID: NCT04540575 Recruiting - Preterm Birth Clinical Trials

Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants

ReDiMOM
Start date: December 3, 2020
Phase: N/A
Study type: Interventional

In the US, the burden of very low birth weight (VLBW; <1500 g) birth is borne disproportionately by black (non-Hispanic black/African American) mothers who are 2.2-2.6 times more likely than nonblack mothers to deliver VLBW infants. This disparity is amplified because black VLBW infants are significantly less likely to receive mother's own milk (MOM) feedings from birth until neonatal intensive care unit (NICU) discharge than nonblack infants, which adds to the lifelong burden of VLBW birth with increased risk of morbidities and greater costs. Pumping is associated with out-of-pocket and opportunity costs that are borne by mothers, unlike donor human milk and formula, which are paid for by NICUs. This innovative trial will determine the effectiveness of the intervention in reducing the disparity in MOM feedings and provide an economic analysis of the interventions, yielding critical data impacting generalizability and likelihood of implementation of results. The investigators hypothesize that mothers who receive intervention will have greater pumping volume and duration and their infants will be more likely to receive MOM at NICU discharge compared to mothers who receive standard of care lactation care and their infants.

NCT ID: NCT04497012 Recruiting - Clinical trials for Very Low Birth Weight Infant

Iron Supplementation and Intestinal Health

Start date: November 17, 2020
Phase: Phase 4
Study type: Interventional

This is a randomized double-blinded study of enteral iron supplementation in Very Low Birth Weight infants. The subjects will be randomized into low dose (2 mg/kg/day) and high dose (6 mg/kg/day) of daily iron supplementation. The primary outcomes are intestinal health including microbiome, inflammation, and barrier function.

NCT ID: NCT04367181 Recruiting - Premature Birth Clinical Trials

DCS Study in Extremely Premature Newborns

Start date: March 15, 2019
Phase: N/A
Study type: Interventional

We are attempting to improve the cerebral monitoring of extremely low gestational age (ELGA) infants, such that in the future, real-time monitoring will be possible, to aid clinicians in their management of these infants. We wish to establish a new NIRS device, diffuse correlation spectroscopy (DCS), as a safe, noninvasive and informative bedside tool for assessing and monitoring brain health in ELGA infants during the first few days of life. It is hoped that this method will provide detailed information on changes in oxygen consumption and metabolism, and cerebral perfusion. This technique will have wide applicability, but for this research study we wish to focus on the effect of blood flow instabilities, intermittent hypotension and hypoxic episodes, pressure passive CBF periods, and hypoperfusion on the preterm brain during the first days of life, and their relationship with incidence of intraventricular hemorrhage (IVH). We aim to recruit 100 premature infants to obtain data to: 1. Test the feasibility of NIRS-DCS to monitor cerebral activity, perfusion and oxygen consumption in extremely premature infants during the first week of life. 2. To assess if these baseline values are impacted by intermittent hypoxic episodes. 3. To assess if cerebral blood flow disturbances correlate with incidence of intraventricular hemorrhage. 4. Correlate the NIRS-DCS findings with clinical outcome at hospital discharge.

NCT ID: NCT04246333 Recruiting - Premature Birth Clinical Trials

Duodenal Feeds in Very Low Birth Weight Infants

Start date: August 7, 2020
Phase: N/A
Study type: Interventional

Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support. These infants are at increased risk for gastroesophageal reflux and aspiration which may exacerbate lung injury. Transpyloric feeds, specifically duodenal feeds, may be used to bypass the stomach and directly feed the duodenum decreasing the amount of gastric reflux contributing to aspiration. Duodenal feeds are equivalent to gastric feeds with regards to nutritional outcomes, and have been shown to decrease events of apnea and bradycardia in premature infants. This study will evaluate the feasibility and safety of duodenal feeds in premature infants. The hypothesis is that duodenal feeds may be safely and successfully performed in premature very low birth weight infants.