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Premature Birth clinical trials

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NCT ID: NCT06067958 Not yet recruiting - Dexmedetomidine Clinical Trials

Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity

Start date: January 2024
Phase: Phase 3
Study type: Interventional

Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed "retinopathy of prematurity". While those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain. Purpose: The goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations. The main questions it aims to answer are: - Does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%). - Does dexmedetomidine cause more adverse effects than placebo. In this crossover study participants will receive either dexmedetomidine or saline 0.9% intranasally 30 minutes before the examination, on top of the current standard of care. The participants will be monitored closely for 5 hours to note differences in adverse effects. The researchers will use video monitoring to assess the pain scores using a standardized and validated scoring system.

NCT ID: NCT06067529 Not yet recruiting - Clinical trials for Premature Ovarian Insufficiency

A Multicenter Observational Study on the Development and Health Effects of Premature Ovarian Insufficiency

POI
Start date: November 1, 2023
Phase:
Study type: Observational

Premature ovarian insufficiency (POI) refers to the occurrence of ovarian hypofunction in women before the age of 40, which seriously affects women's overall health and quality of life. However, there is currently insufficient understanding of the risk factors, pathogenesis, short-term and long-term health effects of POI, and the health effects of the disease, and there is a lack of high-quality evidence to support clinical diagnosis and treatment decisions. This study intends to construct a hospital-based multi-center POI case-control and prospective special disease cohort, after baseline assessment and follow-up monitoring, collect disease characteristics, lifestyle, social psychology, environmental and occupational exposure, biological samples and other data, aiming to observe POI The natural occurrence, progression and health impact of POI, clarify the risk factors of POI, evaluate the impact of POI on women's health and disease risk, and discuss the benefits, risks and options of HRT for POI patients. The results of this study will deepen and expand the understanding of the occurrence and development of POI and its short-term and long-term health effects, provide high-level evidence for optimizing POI prevention, diagnosis and treatment strategies, and establish a long-term management system, laying the foundation for interventional research.

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: NCT06019286 Not yet recruiting - COPD Clinical Trials

Novel Predictors of Premature Aging in COPD Patients

Start date: September 1, 2023
Phase:
Study type: Observational

•Examine whether COPD is associated with accelerated aging using a biological marker of aging and dermatological score

NCT ID: NCT05989438 Not yet recruiting - Prematurity Clinical Trials

Different Intervention Models of Premature Infants Based on the ICF Biopsychosocial Model

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

Prematurity is an important risk factor for delayed neuropsychomotor development. The main objective of this study is to analyze the impact of different intervention models on the neuropsychomotor development of premature babies based on the ICF biopsychosocial model.

NCT ID: NCT05977400 Not yet recruiting - Premature Birth Clinical Trials

NICU Antibiotics and Outcomes (NANO) Follow-up Study

NANO-FU
Start date: April 2024
Phase: Phase 3
Study type: Interventional

The NANO follow-up study is designed to determine whether a simple, cost-effective intervention- withholding antibiotics at birth- reduces clinically relevant outcomes such as behavioral and neurological impairment at 2 years of age. This study will be the largest study evaluating the effects of early antibiotics in children with comprehensive measures of neurodevelopment linked to genomic variants and microbiota interactions.

NCT ID: NCT05971654 Not yet recruiting - Preterm Labor Clinical Trials

Effect Of Azithromycin in Women at Risk of Preterm Labour

Start date: July 30, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to evaluate the benefit of the addition of azithromycin to standard treatments to prolong pregnancy in women having intact membranes and is at risk of or in preterm labour.

NCT ID: NCT05969431 Not yet recruiting - Clinical trials for Stress, Psychological

Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study

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

The goal of this observational study is to compare the paternal hair cortisol as a marker for chronic stress in prematurely born children to maturely born children. The main questions it aims to answer are: - How differ the cortisol level between groups? - How change the cortisol level over time? - Are there secondary outcomes associated to the cortisol level of fathers? Participants will give a hair sample to analyse the cortisol level and fill out questionnaires at three time points. At six months of the infant's age, the investigators will also measure the paternal sensitivity.

NCT ID: NCT05942924 Not yet recruiting - Clinical trials for Infant, Premature, Diseases

The NEU-STIM Trial

NEU-STIM
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.

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.