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Premature Birth clinical trials

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NCT ID: NCT06219525 Enrolling by invitation - Zinc Deficiency Clinical Trials

Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants

ZnVeryPT
Start date: April 2, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to compare the effect of higher (10 mg per day) versus standard (1 mg per day) doses of zinc supplementation The main questions it aims to answer are: - Growth velocities and delta z-scores during the date of start intervention until the end of the time interval (at least 2 weeks of intervention on date of 44 weeks of postmenstrual age or discharge whichever came first) in very preterm infants with a birthweight less than1800 grams. - Growth and neurodevelopment at 24 months postnatal age

NCT ID: NCT06116747 Enrolling by invitation - Preterm Clinical Trials

The SUPPORTED Study - First-time Fathers of Preterm Infants.

Start date: October 31, 2023
Phase: N/A
Study type: Interventional

The purpose is to support first-time fathers of premature infants in early parenthood by promoting early paternal-infant relationships. Improve paternal confidence by involving, knowledge sharing, and guiding them in their premature infants' emotional, nutritional, and developmental needs. The study operates with two study populations: a) first-time fathers, their premature infants, and families, b) health care professionals working with new families in neonatal intensive care units and maternity units and the families' health visitors from the secondary health care sectors. Seven hospitals located in Denmark's five regions participates. Four studies address the key questions for the father's involvement in supportive health care: 1) How do fathers experience their participation in father-groups in the NICU, 2) What are the first-time fathers' needs and preferences for supporting health care, 3) Development of an intervention based on the identified need to support the fathers in early parenting, 4) Study the process and effect of the intervention on paternal confidence and stress. The first question is explored in a qualitative evaluation of an ongoing father-group intervention in a neonatal intensive care unit. The following three questions are studied through an action research approach, identifying first-time fathers' needs for support and the current practices among health professionals towards new first-time fathers of premature infants. Secondly, developing guiding principles for health care professionals to strengthen fathers' partnership in health care. Finally, conducting a quasi-experimental study to evaluate the process and effect of the proposed approaches. The study of this paternal supportive programme, involves perspectives that have not yet been studied in Denmark or internationally.

NCT ID: NCT05990582 Enrolling by invitation - Preterm Birth Clinical Trials

The Alkmaar MLPTI Cohort Study: Outcomes at 9 Years

Start date: August 6, 2023
Phase: N/A
Study type: Interventional

Objective of the study: To examine cognition, motor function, executive functions, speech and language development, behaviour, psychosocial functioning,academic achievement, physical morbidities and growth of MLPTI at the age of 9 years and correlate this with BSID-III-NL scores,growth parameters and body composition at the age of 2 years. Study design: This study will be a prospective open, non-therapeutic exploratory cohort study and can be seen as a continuation on the study with protocol identification number NL50800.094.14, performed in the NWZ Alkmaar between 2014 and 2016. This was a study on growth and neurodevelopment of MLPTI in the first 2 years of life. Study population: The study population is a group of 200 moderate and late preterm children who were born in the NWZ Alkmaar between 2014 and 2016. 100 of these children participated in the aforementioned study on growth and neurodevelopment at the age of 2 years. The oldest children in this group will reach the age of 9 years in 2023. Brothers/sisters/friends of these children aged between 8 and 10 will be asked as control group (n=50). Primary study parameters/outcome of the study: The main study parameters are the IQ-scores of the WISC-V, the motoric scores of the Movement-ABC, the executive functions of the EMMA Toolbox, the presence of morbidities, the growth pattern and the mean blood pressure at 9 years of age. Secondary study parameters/outcome of the study: Secondary outcome parameters are the he behavioural and psychosocial outcomes of the CBCL and the SDQ scores, speech-and language-developmental scores of the CELF-5-NL and CCC-2-NL, MCH Feeding Scale and Teacher Report Form (TRF) scores. Other outcome parameters are the relation between the 9-year outcomes and the BSID-III scores at the age of 2, and the differences between the MLPTI and the control group. Furthermore, we aim to determine the relation between growth and body composition in the first two years of life and the waist circumference, growth parameters and blood pressure at the age of 9 years.

NCT ID: NCT05903313 Enrolling by invitation - Clinical trials for Myocardial Infarction

A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software

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

"Chang Gung ECG Abnormality Detection Software" is a is an artificial intelligence medical signal analysis software that detect whether patients have abnormal ECG signals of 14 diseases by static 12-lead ECG. The 14 diseases were - Long QT syndrome - Sinus bradycardia - Sinus Tachycardia - Premature atrial complexes - Premature ventricular complexes - Atrial Flutter, Right bundle branch block - Left bundle branch block - Left Ventricular hypertrophy - Anterior wall Myocardial Infarction - Septal wall Myocardial Infarction - Lateral wall Myocardial Infarction - Inferior wall Myocardial Infarction - Posterior wall Myocardial Infarction The main purpose of this study is to verify whether "Chang Gung ECG Abnormality Detection Software" can correctly identify abnormal ECG signals among patients of 14 diseases. The interpretation standard is the consensus of 3 cardiologists. The results of the software analysis will be used to evaluate the performance of the primary and secondary evaluation indicators.

NCT ID: NCT05835765 Enrolling by invitation - Premature Birth Clinical Trials

Use of Dynamic Elastometric Body in Preterm Newborns

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

The goal of this prospective pilot study is to test the use of dynamic elastomeric body in a population of preterm newborns with hyperexcitability syndrome. The main questions it aims to answer are: - To evaluate the effectiveness of the body in elasto-compressive material (FLEXA) in addition to standard care; - To evaluate how the use of dynamic elastomeric body promote postural containment, reduce hyperexcitability (tremor and crying), improve the organization of movement and reduce respiratory distress. Participants will be given to routine clinical evaluations that are part of the standard of care of the premature infant admitted to Neonatology. The clinical evaluation shall consist of: - Hammersmith neonatal neurological examination; - Neonatal Intensive Care Unit Network Neurobehavioural Scale (NNNS); - General Movement's (GM's) - Goal Attainment Scaling (GAS) Researchers will compare a study group that will be subjected to treatment with the body in elasto-compressive material and a control group without using the body in elasto-compressive material.

NCT ID: NCT05698836 Enrolling by invitation - Premature Birth Clinical Trials

Cardiovascular Health Assessment of Preterm- and TERm-born Children

CHAPTER
Start date: March 21, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of the CHAPTER study is to help understand how complications during pregnancy, such as preterm birth, affect how childrens' hearts and blood vessels develop.

NCT ID: NCT05645367 Enrolling by invitation - Lipid Disorder Clinical Trials

Associations of Lipid Measures With Premature Myocardial Infarction: a Cross-sectional Study

Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

Acute myocardial infarction (AMI) is the first cardiovascular cause of death that seriously threatens human health worldwide. Its incidence rate and mortality are increasing year by year and becoming younger. According to statistics, the average age of men and women with AMI for the first time is 65.6 years old and 72 years old respectively, of which 4%~10% AMI occurred before 45 years old. At present, there is no uniform age threshold for young AMI. Generally speaking, AMI with onset age less than 55 years for men and 65 years for women is called early-onset AMI, accounting for 5%~13% of AMI. Compared with elderly patients with AMI, patients with early onset AMI have different risk factors, clinical characteristics and prognosis, such as lower proportion of patients with diabetes and hypertension, more single vessel lesions and rare left main artery involvement, and higher long-term recurrence rate and mortality. Although the progress of preventive measures and treatment methods has reduced the hospitalization rate of elderly AMI patients, the number of young AMI patients in hospital is still rising. Therefore, in-depth analysis of the characteristics of risk factors of early onset AMI and early intervention are of great significance to reduce the risk of onset and improve long-term prognosis. Hyperlipidemia is an independent risk factor for coronary heart disease at all ages, and is more closely related to early onset AMI. It is reported that more than 50% of early onset AMI patients are accompanied by hyperlipidemia. However, at present, the research on the relationship between blood lipids and early onset AMI is limited to the comparison of the level of single lipid component between early onset AMI and different control groups, or the comparative analysis of the relationship between a specific lipid component and the risk of early onset AMI with young healthy people. There is no research to compare the correlation between various lipid components and the risk of early onset AMI. Therefore, this study plans to deeply analyze the correlation between different blood lipid components and their ratios and early onset AMI, and further analyze which blood lipid indicators are most closely related to early onset AMI through large sample clinical research data, taking late onset AMI patients as the control, which should be paid early attention to and strictly managed.

NCT ID: NCT05621785 Enrolling by invitation - Premature Birth Clinical Trials

Corticosteroid Use in Premature Babies and Lung Ultrasonografi Use in the Progression to Bronchopulmonary Dysplasia

Start date: March 1, 2022
Phase:
Study type: Observational [Patient Registry]

Bronchopulmonary dysplasia (BPD) is one of the most common morbidities in premature infants and is associated with poor neurodevelopmental outcomes . Although mechanical ventilation and oxygen requirements in premature infants have been identified as triggering mechanisms for the development of inflammation and BPD over time, data now support that a number of perinatal events that may stimulate the inflammatory cascade before birth also have important effects. Corticosteroids such as dexamethasone and hydrocortisone have proven to be beneficial for the prevention and management of postpartum BPD due to their anti-inflammatory properties . With this study, the effects of corticosteroid use on lung ultrasound findings in BPD will be investigated, and acute and chronic lung ultrasonography scores will be recorded. A prospective observational study was planned in the neonatal intensive care unit between 2022 and 2024 in premature infants below 32 weeks of gestational age. Demographic data and Lung Ultrasonography findings of these babies will be recorded. Among the patients who are predicted to go to BPD, in the group using corticosteroids, Lung Ultrasonographic imaging will be performed and the effect of corticosteroids on pulmonary findings will be recorded. It is planned to investigate whether postnatal steroid use has an effect on lung ultrasound findings in preterm infants with BPD.

NCT ID: NCT05619224 Enrolling by invitation - Premature Birth Clinical Trials

Physiotherapy to Improve Feeding Skills in Preterm Infants

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

INTRODUCTION: Suction problems are very common in premature children due to a lack of maturation and orofacial control, the manifestation of a low muscle tone and the incoordination during sucking-swallow-breathe. In addition, there are some problems in different systems that get it worse. AIM: compare oral stimulation programme with a neurodevelopmental stimulation intervention programme combined with an oral stimulation programme, evaluating its effectiveness on feeding development, neuromotor development and other aspects of development. METHODOLOGY: we proposed a prospective parallel group clinical trial with two randomized and independent experimental groups. All preterm infants born between 2022-2023 at University Hospital Torrecárdenas, with nasogastric tube and gestational age between 27-32 weeks will be included. EXPECTED BENEFITS: to have better results when the preterm infant is approached globally, also considering the postural situation of the preterm infant. In addition, it is expected that the development of children treated by combining oral stimulation with neurodevelopmental stimulation will be equated or close to healthy and born-to-term child. RESULTS APPLICABILITY: Improved eating performances will reduce length of hospital stay as well as a greater autonomy improving family situation. It will also allow the reduction of hospital costs and the creation of a new way to attend this problem in preterm children.

NCT ID: NCT05573945 Enrolling by invitation - Premature Birth Clinical Trials

Developmental Care Program in Neonatal Intensive Care Unit

CIN
Start date: May 10, 2022
Phase: N/A
Study type: Interventional

This project is a Randomised Clinical Trial that includes a family centred education intervention and/or non-directive active listening counselling intervention with families of preterm infants at risk for sensori-motor disorders.