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Premature Birth clinical trials

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NCT ID: NCT06189352 Not yet recruiting - Breast Feeding Clinical Trials

Positive Feeding of the Preterm Infant

PoP
Start date: August 2024
Phase: N/A
Study type: Interventional

The goal of this feasibility study is to assess the feasibility to implement a feeding strategy for preterm infants. The main questions it aims to answer are: - Is it feasible to implement the PoP-intervention in a level 3a category Neonatal intensive care unit? - Is the PoP-intervention acceptable for parents of preterm infants and health care personnel working in Neonatal intensive care unit? Parents of preterm infants and health care personnel will be asked to follow a protocol of a feeding strategy based on the preterm infants development and cues throughout the NICU-stay.

NCT ID: NCT06164730 Not yet recruiting - Clinical trials for Heterozygous Familial Hypercholesterolemia

A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease

Start date: May 2024
Phase: Phase 1
Study type: Interventional

VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease (CAD) Who Require Additional Lowering of LDL-C. VERVE-102 Uses Base-editing Technology Designed to Disrupt the Expression of the PCSK9 Gene in the Liver and Lower Circulating PCSK9 and LDL-C. This Study is Designed to Determine the Safety and Pharmacodynamic Profile of VERVE-102 in This Patient Population.

NCT ID: NCT06144450 Not yet recruiting - Infant Development Clinical Trials

Evaluation of Effectiveness of the Web-Based Monitoring Program Given to Mothers of Premature Babies

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

The study was planned to determine the effect of the web-based hospital and home follow-up program given to mothers of premature infants on infant growth-development, repeated hospitalization of the infant, maternal stress, preparation for discharge, home care and problem-solving care skills.

NCT ID: NCT06132542 Not yet recruiting - Clinical trials for Premature Ovarian Failure

Autologous ADMSC Transplantation in Patients With POI

ADMSC
Start date: January 15, 2024
Phase: Phase 1
Study type: Interventional

The primary ovarian insufficiency (premature ovarian failure, premature ovarian insufficiency, premature menopause) is a hypergonadotropic hypogonadism, that failure of the ovarian function in woman younger than 40 years. Fat derived stem cells are mainly mesenchymal stem cells and found to be effective treatment in joint and bone regeneration. We are planning to investigate the effectiveness of adipose stem cell on ovarian tissue regeneration for patients with premature ovarian failure.

NCT ID: NCT06118801 Not yet recruiting - Clinical trials for Necrotizing Enterocolitis

The Effect of Probiotics Added to the Mother's Diet on Preterm Babies

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

Abstract According to the definition by World Health Organization; births before the completion of the 37th gestational week are called, preterm birth. Preterm birth is among the most important causes of mortality and morbidity during infancy. Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in the Neonatal Intensive Care Unit. The most common risk factors are, preterm birth, enteral feeding and bacterial colonization. Late Onset Sepsis (LOS) is one of the most common causes of morbidity and mortality in the preterm infants. A healthy gut microbiota has a key role in developing and maintaining a balanced immune response and establishing the intestinal barrier in the immediate postnatal period. Probiotics come to the fore as means that may be effective in preventing NEC and LOS. Although it is widely accepted that, breast milk has its own microbiota, the origin of these bacterial populations in the milk, has not been fully understood. The new information regarding especially the anaerobic species associated with the intestinal environments that cannot be found in the aerobic environments, suggests an endogenous route to the mammary gland through the presence of the entero-mammary pathway. The aim of this project is to determine the effect of the probiotics added to the maternal diet on the incidence of encountering NEC and LOS in the preterm infants. The unique value of this project is that, 80 ml of probiotic yogurt will be given to mothers of the preterm infants, who still breastfeed their babies, for 20 days and the effects on the baby will be examined in the scope of the study. The study has been planned to be conducted as a randomized controlled study in the Neonatal Intensive Care Unit of Şanlıurfa Training and Research Hospital. The power analysis was performed with G*Power for the sample size of the study, which has an experimental/control design structure. The sample size was determined as 50 in total. Data collection tools were organized as Mother and Infant Introductory Information Form (23 questions), Mother and Infant Follow-up Form during Probiotic Implementation (7 questions). At the beginning of the study, all mothers will fill out the mother and baby introductory information form, and the mothers in the experimental group will be given 80 ml probiotic yogurt support once a day for 20 days. In addition to that, all the babies will be monitored for growth once a week, throughout the process. Their status of regular breastfeeding, whether they are diagnosed with NEC and LOS, the time of transition to oral feeding, their bilirubin levels, their status of receiving phototherapy and their discharge durations will be evaluated, and a questionnaire that consists of scale questions will be applied after the discharge. As a result of this project, it is aimed with the probiotic that will be added to maternal nutrition to reduce the encounter of NEC and LOS in preterm infants, to positively affect the intestinal microbiota by preventing dysbiosis in these infants, to protect them from very important problems such as NEC and LOS as well as accelerating the transition to oral feeding, to help them gain weight, to shorten the duration of receiving phototherapy and hospitalization by reducing the bilirubin levels.

NCT ID: NCT06110364 Not yet recruiting - Clinical trials for Premature Ventricular Contraction

Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

Start date: October 2023
Phase: Phase 3
Study type: Interventional

Prospective randomized control pilot study

NCT ID: NCT06103227 Not yet recruiting - Preterm Birth Clinical Trials

The Effect of Low Doses of Prednisone on the Prolongation of Pregnancy in Threatened Preterm Birth

Start date: December 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to test the effect of low dose of prednisone in prevention of preterm labour in single pregnancies. The main question it aims to answer is does prednisone prolong singleton pregnancy in threatened preterm birth and reduce mortality and morbidity of newborns, without harmful consequences for mother and the foetus. Participants will be: - administered low dose of prednisone in a period of total 3 weeks on top of standard therapy - drown blood for standard laboratory tests - cervical swab and urine for urinoculture will be taken and - asked to sign Informed Consent Researcher will compare low dose of prednisone to standard therapy

NCT ID: NCT06096961 Not yet recruiting - Premature Birth Clinical Trials

The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment

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

The goal of this [type of study: randomized controlled clinical trial] is to [determine the effect of applying the scent of premature newborns who cannot be breastfed to the mother on the mother's milk amount, salivary cortisol level and mother-infant attachment.] in [mothers of premature babies]. The main question[s] it aims to answer are: - [Hypothesis 1: There is a difference in the amount of milk of the mother.] - [Hypothesis 2: There is a difference in the level of cortisol in the mother's saliva.] - [Hypothesis 3: There is a difference in terms of mother-baby attachment level.] Participants will [Participants will express milk and record the amount of milk.]. If there is a comparison group: Researchers will compare [control and experimental groups] to see if [difference in amount of milk, cortisol level, baby attachment].

NCT ID: NCT06075992 Not yet recruiting - Premature Birth Clinical Trials

Massage Application and Motor Performance, Stress Assessment in Premature Babies

Start date: January 20, 2024
Phase: N/A
Study type: Interventional

In our study, the effect of infant massage applied in the intensive care unit on motor performance and stress hormones in premature babies will be examined. The number of patients to participate in the study was determined as 30. Appropriate babies will be determined and divided into 2 groups by drawing lots. After recording the demographic information of the babies who meet the inclusion criteria, the Baby Motor Performance Test (TIMP) and the baby's motor performance evaluation consisting of postural control and selective extremity movements, and the stress level of the babies will be evaluated by looking at cortisol and adrenocorticotropic hormone (ACTH) hormones. In addition, Field baby massage will be given to the application group. It is seen that there are limited studies in the literature on the effect of infant massage applied in the intensive care unit on motor performance and stress hormones in premature infants. The results of this research will provide useful information for premature babies hospitalized in intensive care.

NCT ID: NCT06072625 Not yet recruiting - Premature Clinical Trials

Enteral Feeding of Premature Babies and Olive Oil Supplementation

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

It is a two-arm prospective interventional study. 40 babies in both groups will be enrolment in the study. In the intervention group, babies will take 1 ml/kg/day of the study product (ULTRA PREMIUM) after full enteral feeding. Supplementation will continue until discharge or the 36th week. Blood samples will be taken for serum Total antioxidant capacity and Malondialdehyde levels before the intervention and on the 14th day of the control group. At the end of the study, serum will be taken again for control values. Daily lipid intake amounts will be recorded through breast milk analysis. Lipid profile will be monitored weekly The growth parameters of babies will be monitored daily It will be evaluated at the end of the study in terms of ROP, BPD, and NEC. At the end of the study, the data of babies in both groups will be compared.