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Preterm Birth clinical trials

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NCT ID: NCT06362798 Not yet recruiting - Preterm Birth Clinical Trials

Effect of Support for Low-Income Mothers of Preterm Infants

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

Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 33 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development.

NCT ID: NCT06334107 Not yet recruiting - Preterm Birth Clinical Trials

Mitochondrial DNA Signatures of Poor Aerobic Exercise Trainability in Young Adults Born Preterm

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

Young adults born very preterm (32 weeks gestation or earlier) do not respond well to aerobic exercise training, meeting the recommendations set by the Physical Activity Guidelines for Americans, where they do not increase their fitness level (or cardiorespiratory fitness). Thus, they do not receive the health benefits of exercise. Achieving physical fitness through aerobic exercise training is the most cost-effective method for preventing and treating many diseases. Young adults born very preterm also have a higher risk of these conditions. Thus, their inability to respond to increase their fitness is a major problem. One likely explanation for poor exercise trainability and increased heart disease risk in young adults born very preterm is the effect of the early birth on the major energy producers in all our cells: Mitochondria. During late-stage gestation, mitochondria change from relying on sugar as a major fuel source to fat. Unfortunately, individuals born very preterm miss this transition in fuel source reliance, which causes significant stress and damage to mitochondria. Mitochondria are critical for post-natal organ development; thus, it is thought that preterm birth-induced mitochondrial dysfunction is the underlying cause of poor trainability and high disease risk in young adults born very preterm. Indeed, mitochondrial dysfunction is evident in these individuals. To date, there is not a way to help young adults born preterm improve their fitness level. One likely target is in the mitochondria: it's DNA. Mitochondrial DNA helps determine how mitochondria function and can be damaged under stress. Our goal in this proposed work is to determine the role of mitochondrial DNA in mitochondrial dysfunction and its link to their poor trainability. Questions: 1. Are there mitochondrial DNA markers linked to mitochondrial dysfunction and poor exercise trainability in young adults very born preterm? 2. Do mitochondrial DNA in young adults born very preterm respond differently to aerobic exercise training than those born at term? The investigators expect this work will show mitochondrial DNA changes linked to mitochondrial dysfunction and poor trainability, which can be used for future targets to improve health. This work supports AHA mission by helping to identify a marker in individuals born very preterm linked to their higher heart disease risk and death early in life.

NCT ID: NCT06259604 Not yet recruiting - Preterm Birth Clinical Trials

Preterm Infant Oral Motor Intervention (PIOMI)

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

The purpose of this research; The aim of this study is to examine the effects of oral motor intervention (PIOMI) and combined kangaroo care applied to preterm babies on weight gain, oral feeding skills, transition to full oral feeding and discharge time.

NCT ID: NCT06234332 Not yet recruiting - Obesity Clinical Trials

Peking University Birth Cohort in Weifang (PKUBC-WF)

Start date: February 1, 2024
Phase:
Study type: Observational

The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.

NCT ID: NCT06103227 Not yet recruiting - Preterm Birth Clinical Trials

The Effect of Low Doses of Prednisone on the Prolongation of Pregnancy in Threatened Preterm Birth

Start date: December 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to test the effect of low dose of prednisone in prevention of preterm labour in single pregnancies. The main question it aims to answer is does prednisone prolong singleton pregnancy in threatened preterm birth and reduce mortality and morbidity of newborns, without harmful consequences for mother and the foetus. Participants will be: - administered low dose of prednisone in a period of total 3 weeks on top of standard therapy - drown blood for standard laboratory tests - cervical swab and urine for urinoculture will be taken and - asked to sign Informed Consent Researcher will compare low dose of prednisone to standard therapy

NCT ID: NCT06055062 Not yet recruiting - Preterm Birth Clinical Trials

Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very Preterm Children at 5.5-years-old

Spectro5-5
Start date: October 2023
Phase:
Study type: Observational

Background: Compared to term-born peers, very preterm children generally perform poorly in executive functions, with a significant impact on learning at school and quality of life. These EF deficits are related to microstructural abnormalities in white matter and subcortical brain structure. Objective: To investigate if an alteration of cerebral metabolism in very premature at term corrected-age correlates to executive dysfunctions at school age. Design, setting, patients: Very preterm patients eligible for Epirmex underwent cerebral Magnetic Resonance Imaging at term-equivalent age and 1H-MRS using a monovoxel technique. The volumes of interest were the posterior periventricular white matter zone and the basal ganglia and thalamus The ratios of N Acetyl Aspartate (NAA) to Choline (cho), NAA to Creatine(Cre), Cho to Cr, and Lac (Lactate) to Cr were calculated. Main outcome measures: Survival at 5 ½ years with or without neurodevelopmental disabilities (composed of cerebral palsy, visual, hearing, cognitive deficiency, behavioral difficulties, or developmental coordination disorders) were described. The executive functions were assessed using two indices from the Wechsler Intelligence Scale measured in the EPIPAGE 2 cohort at age five-and one-half years: the Working Memory Index (WMI) and the Fluid Reasoning Index (FRI).

NCT ID: NCT05934318 Not yet recruiting - Pregnancy Clinical Trials

L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)

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

There are few safe, effective, and affordable interventions to improve pregnancy outcomes in low resource settings where the highest rates of poor birth outcomes occur. L-citrulline is naturally found in many foods and is changed into another important amino acid, L-arginine, in the body. L-arginine is important for the growth of a healthy placenta and healthy baby. Adding L-citrulline to the diets of pregnant women may be an effective and affordable way to improve the health of their babies.The goal of the AGREE trial is to test whether a dietary supplement containing a common food component, an amino acid called L-citrulline, can help pregnant Kenyan women at risk of malaria have healthier pregnancies and healthier babies. 2,960 pregnant Kenyan women will be enrolled and randomly assigned to take either a twice daily dietary supplement containing L-citrulline or a placebo supplement without additional L-citrulline. Maternal participants will be seen every month until delivery and at weeks 1 and 6 after birth. Infants will also be followed up at ages 6, 12, 18, and 24 months. The primary outcome of the study is 'adverse pregnancy outcome', a composite of foetal loss (miscarriage or still birth), preterm birth, low birth weight, small for gestational age or neonatal mortality. The results of the AGREE trial could help to guide obstetric and public health policy and provide a sustainable solution that could be implemented at the community level.

NCT ID: NCT05787509 Not yet recruiting - Preterm Birth Clinical Trials

Prolonged Progesterone to Prevent Preterm Birth From IVF - ET

Start date: April 1, 2023
Phase: Phase 4
Study type: Interventional

To investigate the incidence of preterm birth in IVF fresh embryo transplantation cycle patients after prolonged vaginal progesterone treatment

NCT ID: NCT05670145 Not yet recruiting - Pregnancy Related Clinical Trials

PRECISE - Objective Measures and Observations of Physical Exposures Among Pregnant Employees in the Danish Workforce

PRECISE
Start date: January 2, 2023
Phase:
Study type: Observational [Patient Registry]

Occupational physical activity during pregnancy may decrease blood supply to the uterus and be connected to negative pregnancy outcomes. Every year, this notion prompts many pregnant women to be absent from their workplace in order to protect themselves and their unborn children. However, little is known about the actual extent and impact of physical workloads among expecting mothers in Denmark and whether this high rate of pregnancy related absence is necessary. In consequence, current guidelines from the Danish Working Environment Agency have omitted former limits on lifting during pregnancy due to lack of evidence. (1) Former studies have mainly been based on self-reported data with no measurements of exposures. A comprehensive evaluation of physical exposures in Danish workplaces and potential consequences for pregnant women will provide a rational basis for organization of work with improved options for prevention of adverse health effects. By use of measurements, observations and real-time self-report, the overall aim of the project is to attain precise data on physical workloads (lifting, standing/walking and forward bending) among pregnant employees in the Danish workforce, and investigate how these relate to discomforts, complications and negative pregnancy outcomes.

NCT ID: NCT05512052 Not yet recruiting - Preterm Birth Clinical Trials

Preventing Preterm Birth With a Negative Pressure Cervical Cup: a Feasibility Study

Start date: April 2023
Phase: Phase 1
Study type: Interventional

The goal of this Phase I clinical trial is to generate proof-of-concept data to demonstrate that a cervical cup in combination with vacuum application will create negative pressure on uterine cervical tissue, thereby creating immediate cervical stiffness in order to prevent cervical ripening that is associated with spontaneous preterm birth. Aim #1: Conduct a Phase I clinical study. 1A: Evaluate the ability of a cervical cup to improve cervical tissue physiology of uterine cervices in vivo for nonpregnant women. 1B: Evaluate the ability of a cervical cup to be safely placed and removed on uterine cervices in vivo for nonpregnant women.