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Premature Birth clinical trials

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NCT ID: NCT06224816 Recruiting - Premature Lungs Clinical Trials

Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants

M3DPREMAT
Start date: April 16, 2024
Phase: N/A
Study type: Interventional

Clinical trial with crossed groups, open, masked for the evaluation of the main outcome. Inclusion of all premature infants with a birth weight less than 1500 g requiring Non-invasive Ventilation (NIV). Premature will be randomised to start alternatively with MT or 3DM. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days. To compare the time in which preterm maintain SatO2 below 85% with the 3DM versus the traditional mask (TM) in preterm < 1500 g. Other secondary objectives regarding ventilation enhancement will be assessed, such as the number of bradycardias, cardiorespiratory arrest and need for resuscitation in the context of apnea. Also, skin lesions of the nose resulting from the pressure applied by any of the masks (TM or 3DM) and the need for analgesia and/or sedation for pain control or discomfort will be assessed. Parental perception and satisfaction will be assessed.

NCT ID: NCT06224764 Recruiting - Premature Birth Clinical Trials

Assessment of the Impact of the Return Home of Premature Newborns Less Than 2 Kilos Morbidity/Mortality

Petit-Poids
Start date: February 21, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the impact of discharge from hospital with a weight of less than 2 kilos. To do this, the investigator will look at the short-term and long-term outcome of newborns weighing less than 2 kilos who were discharged from the neonatology department at the NOVO hospital between 2012 and 2023.

NCT ID: NCT06203262 Recruiting - Clinical trials for Ventricular Tachycardia

Ventricular Catheter Ablation Study (VCAS)

VCAS
Start date: April 12, 2024
Phase: N/A
Study type: Interventional

This is a prospective safety and feasibility study to evaluate the safety of the FieldForceâ„¢ Ablation system in patients with ventricular arrhythmia divided into two groups: VT (VCAS-I) and frequent premature ventricular complex (VCAS-II).

NCT ID: NCT06202547 Recruiting - Clinical trials for Premature Ovarian Failure

Intra-ovarian Injection of MSC-EVs in Idiopathic Premature Ovarian Failure

Start date: February 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Premature ovarian failure (POF) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. POF is characterized by menstrual disturbance (amenorrhea or oligomenorrhea) with raised gonadotrophins and low estradiol. The prevalence of POF is 1-2%. Extracellular vesicles (EVs) are membrane-packed vesicles that are secreted by a variety of cell types, including T cells, B cells, dendritic cells, platelets, mast cells, epithelial cells, endothelial cells, neuronal cells, cancerous cells, oligodendrocytes, Schwann cells, embryonic cells, and mesenchymal stromal cells-derived (MSCs). MSCs-EV more stable and induce stronger signaling and are produced in higher concentrations than stem cells. They demonstrate no inherent toxicity, are not associated with any long-term maldifferentiation of engrafted cells or tumor generation, and carry no apparent risk of aneuploidy or immune rejection following in vivo allogenic administration.Several studies have evaluated the safety and possible efficacy of injection MSCs-EV for the treatment of premature ovarian failure in animal models. Based on the available evidence, the study was designed with the aim of investigating the safety and effectiveness of intraovarian injection of MSCs-EV in patients with POF diagnosis.

NCT ID: NCT06201962 Recruiting - Sleep Clinical Trials

Effect of Massage and Foot Reflexology on Newborns' Sleep

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

Purpose: Newborns undergo biochemical and physiological changes involving all their systems in the first days of their lives and may experience difficulties in adapting to extrauterine life for various reasons. Leaving the warm, dark, quiet, calm, fluid-filled mother's womb of newborns whose systems are not yet mature and placing them in the intensive care unit with many stimuli creates intense stress and negatively affects the sleep-wake pattern required for growth-development and neurodevelopment. It is intensive for the development of newborns' neurosensory systems. They have sleep requirements. It is known that the brain activity of newborns during the intrauterine period is similar to REM (Rapid Eye Movement) sleep activity, they sleep more than adults, and they spend most of their sleep in the REM sleep period. For this reason, our research will be conducted to examine the effects of massage and foot reflexology applied to preterm newborns on sleep. Design and Methods: This randomized experimental study will be carried out on 105 preterm newborns with gestational weeks between 30-37, hospitalized in the neonatal intensive care unit of a city hospital. The researcher will apply massage (n:35) and foot reflexology (n:35) to the newborns for 15 minutes, twice a day for 2 days. No intervention other than routine clinical practices will be applied to the control group (n:35). The 24-hour sleep of the newborns included in the study will be monitored with a sleep-wakefulness measuring device before the application and on the day the naps end, and will be recorded in the newborn follow-up form. Statistical analysis will be performed using percentages, means and ANOVA test.

NCT ID: NCT06186453 Recruiting - Preterm Clinical Trials

Effectiveness of Bonding-Based Education Intervention

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

The study aimed to determine the impact of the Father-Preterm Newborn Bonding Programme (B-PreBAP) on fathers' parenting behaviours, stress levels, and support needs. Additionally, the study aimed to investigate the effect of B-PreBAP on the stress levels of preterm newborns.

NCT ID: NCT06172855 Recruiting - Clinical trials for Premature Ejaculation

The Study on the Effectiveness and Safety of Electroacupuncture at ST36 in Treating Primary Premature Ejaculation

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

A pilot prospective single-arm cohort study on the Effectiveness and Safety of Electroacupuncture at ST36(Zusanli) in Treating Primary Premature Ejaculation

NCT ID: NCT06163586 Recruiting - Massage Therapy Clinical Trials

Infant Massage in the NICU

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about the effects of Neonatal Touch and Massage Therapy on premature babies. The main questions it aims to answer are: - Do babies who receive Neonatal Touch and Massage Therapy get discharged sooner from the NICU - Does Neonatal Touch and Massage Therapy have a beneficial effect on weight gain, pain and stress responses, and neurodevelopmental outcomes. Participants assigned to the treatment group will receive Neonatal Touch and Massage Therapy while admitted to the NICU. Researchers will compare their outcomes to a control group, receiving standard NICU care, to see if there are any differences in the length of hospital stay, weight gain, pain scores, neurodevelopmental outcomes, and incidence of other common conditions associated with prematurity.

NCT ID: NCT06157203 Recruiting - Preterm Birth Clinical Trials

Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients

Start date: May 6, 2023
Phase:
Study type: Observational

This is an observational study of pregnant persons in threatened labor. The study device will record electromyography signals, then the signals will be examined to determine who is in true labor and who is in threatened labor. The two goals are: - To establish the thresholds for the Contraction Synchronization Index (CSI) and the False Labor Index (FSI) to be used by the Labor Status Monitor to diagnose in-Labor or Not-in-Labor for preterm patients with threatened labor - To obtain feedback from subjects and providers to assist with enhancing patient comfort and provider training.

NCT ID: NCT06154148 Recruiting - Preterm Birth Clinical Trials

Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion vs. Traditional

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

This is a prospective, controlled randomized study designed to compare the effects of two methods of skin-to-skin positioning of preterm infants: the prone positioning method currently used (according to the World Health Organization's recommendations) and the recent "sustained diagonal flexion" method (SDF) on the daily duration of skin-to-skin contact.