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Premature Birth clinical trials

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NCT ID: NCT06153771 Recruiting - Clinical trials for Extremely Premature Newborn (Born Before 32 Weeks' Gestation)

Description of Changes in NIRS as a Function of Ductus Arteriosus Status in Very Premature Babies Born Before 32 WG at the DIJON University Hospital

CAPNIRS
Start date: October 16, 2023
Phase:
Study type: Observational

Monitoring patent ductus arteriosus is currently performed using echocardiography, an operator-dependent examination which requires holding the child on their back and which is potentially time-consuming. This test is usually carried out on days 2, 4 and 7 after birth. NIRS (near-infrared spectroscopy) is a non-invasive method of monitoring tissue oxygen saturation using infrared light. The aim of the study was to investigate an association between cerebral and renal NIRS data and ductus arteriosus status obtained by echocardiography.

NCT ID: NCT06151613 Recruiting - Preterm Birth Clinical Trials

Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies

NIEM-O
Start date: November 22, 2023
Phase: N/A
Study type: Interventional

The goal of this single centre cohort intervention study with historical controls, is to investigate the effect of implementing continuous antepartum electrophysiological CTG (eCTG) monitoring at the Obstetric High Care (OHC), on perinatal and maternal outcomes and obstetric care. The main aim is to investigate the effect of both monitoring methods on: - primary outcome: perinatal outcomes (a composite of perinatal mortality or major neonatal morbidity) until hospital discharge - secondary outcomes: Maternal mortality, neonatal morbidity, satisfaction for both patient and caregiver, duration of pregnancy, switch of monitoring method, duration of admission to the OHC, timing (planned or emergency) and number of obstetric interventions (such as caesarean section), and admission and duration of admission to the NICU (neonatal intensive care unit). Eligible women will be prospectively included in the cohort receiving standard treatment: CTG monitoring intermittent up to three times a day. From these eligible women, a random sample (464) of the prospective cohort (511) will be offered to receive a new monitoring method: 24/7 eCTG monitoring. In order to strengthen the comparison between the two groups (eCTG and standard treatment), additional data from 1400 women who received standard treatment in 2014-2019 will be collected retrospectively.

NCT ID: NCT06145061 Recruiting - Clinical trials for Premature Ovarian Insufficiency

Evaluation on Biological Characteristics of Acupoints in Premature Ovarian Insufficiency

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

Acupuncture has been widely used in the treatment of Premature Ovarian Insufficiency(POI), but the selection of acupoints is indeterminate and lacks biological basis.In recent years,some studies suggested the "acupoint sensitization",that is,changes such as pain sensitivity and heat sensitivity appear on the acupoints under disease state.The biological characteristics of acupoints can reflect the state of local tissue and might be a potential factor for guiding acupoint selection. This study aims to compare the temperature and pain threshold of acupoints between POI patients and the healthy population.At the meantime,clinical diagnosis of POI is based on clinical symptoms and Follicle Stimulating Hormone (FSH).However,FSH fluctuates so much that prediction accuracy is not high and clinical application is limited.Therefore, given the lack of proper diagnostic accuracy in POI and the concept of "acupoint sensitization",it is necessary to summarize the changes of biological characteristics of related acupoints under physiological and pathological conditions as an auxiliary means to improve the diagnostic rate of POI.

NCT ID: NCT06125860 Recruiting - Preterm Birth Clinical Trials

BEP Targeting Strategies in Ethiopia

BEP
Start date: August 7, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. The main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal BEP targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal BEP provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal BEP targeting strategies. Pregnant women will be enrolled during pregnancy, assigned to different strategies of BEP supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different BEP targeting strategies on pregnancy, maternal, and child outcomes.

NCT ID: NCT06122506 Recruiting - Preterm Birth Clinical Trials

Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage

NORACT
Start date: November 9, 2023
Phase: N/A
Study type: Interventional

Every year 15 million babies are born prematurely, which can lead to death or life-long disabilities. It is often caused by a dysfunction of the uterine cervix, which constitutes the narrow channel between the vagina and womb. During pregnancy, this channel must remain closed until the beginning of term labor. A weak cervix may not withstand the weight of the fetus, the amniotic fluid and the placenta and the cervical canal will open and cause late miscarriage or preterm delivery. To prevent this, a band (cerclage) can be applied around the cervix either vaginally or laparoscopically prior to a new pregnancy. To evaluate which treatment is best for most women, we will randomize (allocate by chance) women at risk for preterm birth, to either vaginal cerclage or laparoscopic cerclage in the Nordic countries and England

NCT ID: NCT06121388 Recruiting - Clinical trials for Premature Ovarian Failure

Brain MRI Imaging Changes and Associated Factors on Cognition Function in Patients With Premature Ovarian Failure

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

The purpose of this study is to investigate the brain MRI imaging changes and associated factors on cognition function in patients with premature ovarian failure.

NCT ID: NCT06117982 Recruiting - Clinical trials for Premature Ovarian Failure

The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency

Start date: October 13, 2023
Phase: Phase 2
Study type: Interventional

The goal of this pilot study is to improve ovarian reserve markers in patients with premature ovarian insufficiency. The main question it aims to answer is: - Will treatment with G-CSF allow improvement in markers of ovarian reserve?

NCT ID: NCT06111898 Recruiting - Cerebral Palsy Clinical Trials

Neuro-biomechanical Determinants for Motor Behavior in High-risk Infants

BAMBI
Start date: October 10, 2023
Phase:
Study type: Observational

This project focuses on motor development, muscle growth and muscle activity. Using advanced, instrumented tests such as , the link between muscles and the movement characteristics will be studied. In addition, the evolution of these neuro-biomechanical determinants during the first year of life will be investigated. The examinations are planned for a group of high-risk infants (e.g. premature birth, cases of asphyxia, etc.) compared with a group of infants with typical development.

NCT ID: NCT06110481 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Reversibility of Bronchial Obstruction in Children Born Preterm

Start date: April 1, 2021
Phase:
Study type: Observational

This observational study aims to compare responses to different, commonly used inhaled bronchodilators in children born preterm with bronchial obstruction at spirometry. All children were diagnosed with Chronic Lung Disease of Immaturity (CLDI). The main questions are: - Is any inhaled bronchodilator or their combination generally superior in children with CLDI when assessing the reversibility of bronchial obstruction? - Is there an individual difference in the effect of betamimetic, anticholinergic or their combination between children with CLDI? Participants will: - Come to our clinic in a stable state without acute infection and they will be randomly assigned to the first inhaled bronchodilator. - They will then perform a spirometry test before and after the inhalation of the drug. - This visit will repeat 3 times, each with a different bronchodilator (beta2agonist, anticholinergic and their combination).

NCT ID: NCT06109285 Recruiting - Clinical trials for Retinopathy of Prematurity

Validation of i-ROP DL to Detect More Than Mild ROP

Start date: November 29, 2023
Phase: N/A
Study type: Interventional

In this study, the investigators aim to improve image acquisition and preprocessing pipeline for FDA application. Our previous research has used various methodologies to identify images to input into the algorithm. The investigators aim to evaluate the effect of image quality and field of view on the output of the device in addition to performing a precision study to evaluate the effect of different camera operators on image selection and device output. Additionally the investigators aim to assist conducting pivotal clinical study for assistive diagnosis. Based on two previous meetings with the FDA, the clinical study will test the following hypothesis: use of the i-ROP DL VSS improves the accuracy of plus disease diagnosis among clinicians performing telemedical review of images. The investigators also aim to assist in conducting pivotal clinical study of autonomous ROP screening. Preliminary data suggests that the i-ROP DL system could achieve 100% sensitivity for detection of severe ROP. The investigators will perform a clinical study to support a revised indication for use as an autonomous AI screening device. Output of the i-ROP DL system will be compared to masked telemedicine grading for identification of referral-warranted and treatment-requiring ROP.