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Premature Birth clinical trials

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NCT ID: NCT04639518 Recruiting - Pre-term Infant Clinical Trials

Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants

Start date: September 10, 2020
Phase: N/A
Study type: Interventional

This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without HMOs).

NCT ID: NCT04638101 Active, not recruiting - Preterm Birth Clinical Trials

Building the Path to Resilience in Preterm Infants: Mindfulness-based Intervention

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

Yearly 15 million babies worldwide are born too soon. 10% of these preterm births occur very early before 32 weeks of gestation and these newborns are at high risk for neurodevelopmental disorders later in life. Neurocognitive disorders now touch 27% of the European population, and 5% or 3.3 million children suffer from social and learning difficulties, including attention-deficit hyperactivity disorders and autism, whose rates are increasing and prematurity contributes to this rise. Cognition, and socio-emotional competence are based on intact brain structure and functions that are formed early in development, both pre- and post-natally, and are heavily influenced by environment. Ramon y Cajal in his studies on the making of the brain clearly stated: "The total arborisation of a neuron represents the graphic history of conflicts suffered during its developmental life". Understanding how environment affects early brain development and defining timing and mode of early interventions to enhance brain development in high risk populations, such as preterm infants, is currently acknowledged as a fundamental endeavor for the scientific community (see guidelines of the National Scientific Council for the Developing Child). Interventions to improve and maintain cognitive and socio-emotional skills are to become an essential tool of medical care for high-risk infants. The goal of this study is to test the impact of a Mindfulness-based intervention - considered to target brain networks previously described as affected by prematurity and improve socio-emotional and executive functions. Mindfulness based intervention (intentional self-regulation of attention) will be performed in 10-13 year old preterm children, both from our prior studied preterm cohorts. Overall, our planned research will fill an important gap in our theoretical understanding of the brain vulnerability linked to prematurity. Even more importantly, the compelling issue of how to build cognitive and emotional resilience in preterm children will be addressed by preventing the onset of difficulties and reducing them with appropriate interventions.

NCT ID: NCT04638023 Completed - Clinical trials for Previous Mid Trimester Miscarriage

Arabin Pessary in Singleton Pregnancy

Start date: January 1, 2017
Phase:
Study type: Observational

This was a retrospective study sharing the experience of women high risk for spontaneous preterm birth managed by Arabin pessary.

NCT ID: NCT04637880 Completed - Clinical trials for Vitamin d Deficiency

25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders

VIDIS
Start date: July 2012
Phase:
Study type: Observational

Evaluation of 25- Hydroxyvitamin D levels in pregnant women in Austria and potential related disorders Hypothesis: Austrian pregnant women are Vitamin D deficient Present vitamin D supplementation in pregnancy is insufficient Vitamin D deficiency is associated with pregnancy related disorders like preeclampsia

NCT ID: NCT04637230 Recruiting - Atrial Fibrillation Clinical Trials

Prevention of Stroke and Sudden Cardiac Death by Recording of 1-Channel Electrocardiograms

PRICE
Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

Single-channel electrocardiograms (lead I of 12-lead surface ECG; 30 seconds) will be collected from subjects/patients at 11 clinical centers in Germany to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms. Heart rhythms of interest are normal sinus rhythm (SR), atrial fibrillation (AF), atrial premature beats (APBs), ventricular premature beats (VPBs), and nonsustained ventricular tachycardia (VT). Per diagnosis, 20,000 ECGs are required, for a total of 100,000 ECGs to be obtained from approximately 10,000 subjects/patients.

NCT ID: NCT04634604 Terminated - Clinical trials for Retinopathy of Prematurity

A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP

ROP3
Start date: April 27, 2022
Phase: Phase 3
Study type: Interventional

This randomized clinical trial will compare retinal outcomes with low-dose intravitreous bevacizumab (0.063 mg) versus laser photocoagulation as treatment for infants with type 1 retinopathy of prematurity (ROP). The study also will assess neurodevelopment, refractive error, visual acuity, and peripheral visual fields.

NCT ID: NCT04634578 Recruiting - Clinical trials for Retinopathy of Prematurity

Bevacizumab Treatment For Type 1 ROP

ROP4
Start date: May 18, 2022
Phase: Phase 2
Study type: Interventional

Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.

NCT ID: NCT04632017 Recruiting - Sepsis Clinical Trials

Computerized Cardiotocography Monitoring of Fetuses With pPROM

COCA-PROM
Start date: June 15, 2020
Phase:
Study type: Observational

Preterm premature rupture of membranes (PPROM) is associated with neonatal complications leading to a high rate of cerebral palsy, sepsis, and death. Choosing the best time of delivery is crucial to improve fetal outcome. The balance is between a premature delivery exposing the infant to all the risk of prematurity, and keeping the baby in utero, prolonging the exposure to an adverse intrauterine milieu. There are no objective and reproducible tools to help in this decision-making process. Techniques most frequently used for fetal surveillance are biased by high inter- and intra-observer variability. Computerized cardiotocography (cCTG) identifies several objective parameters related to fetal heart rate (FHR) to determine fetal well-being. cCTG has been successfully used in fetuses with intrauterine growth restriction, but it has never been used in prospective studies to assess its role in the management of fetuses with PPROM. The investigators designed a case control study to highlight cCTG differences in PPROM pregnancies versus physiological pregnancies, to establish the effectiveness in predicting adverse outcome, and to develop a score to predict neonatal outcome.

NCT ID: NCT04623684 Completed - Clinical trials for Retinopathy of Prematurity

Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial

Start date: March 24, 2020
Phase: Phase 4
Study type: Interventional

The purpose is to assess whether the use of microdrop instillation of phenylephrine 1.67% and tropicamide 0.33% maintains mydriatic efficacy while presents an improved safety profile compared with standard drops of phenylephrine 1.67% and tropicamide 0.33%, which is routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit.

NCT ID: NCT04621136 Completed - Clinical trials for Retinopathy of Prematurity

PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity

Start date: November 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, single-arm phase I/II trial to evaluate the safety and efficacy of Rho-associated protein kinase(ROCK) inhibitor Ripasudil eye drops for preterm infants with Retinopathy of Prematurity(ROP).