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Premature Birth clinical trials

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NCT ID: NCT06336668 Not yet recruiting - Clinical trials for Feeding; Difficult, Newborn

Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation

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

Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives. The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks.

NCT ID: NCT06334107 Not yet recruiting - Preterm Birth Clinical Trials

Mitochondrial DNA Signatures of Poor Aerobic Exercise Trainability in Young Adults Born Preterm

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

Young adults born very preterm (32 weeks gestation or earlier) do not respond well to aerobic exercise training, meeting the recommendations set by the Physical Activity Guidelines for Americans, where they do not increase their fitness level (or cardiorespiratory fitness). Thus, they do not receive the health benefits of exercise. Achieving physical fitness through aerobic exercise training is the most cost-effective method for preventing and treating many diseases. Young adults born very preterm also have a higher risk of these conditions. Thus, their inability to respond to increase their fitness is a major problem. One likely explanation for poor exercise trainability and increased heart disease risk in young adults born very preterm is the effect of the early birth on the major energy producers in all our cells: Mitochondria. During late-stage gestation, mitochondria change from relying on sugar as a major fuel source to fat. Unfortunately, individuals born very preterm miss this transition in fuel source reliance, which causes significant stress and damage to mitochondria. Mitochondria are critical for post-natal organ development; thus, it is thought that preterm birth-induced mitochondrial dysfunction is the underlying cause of poor trainability and high disease risk in young adults born very preterm. Indeed, mitochondrial dysfunction is evident in these individuals. To date, there is not a way to help young adults born preterm improve their fitness level. One likely target is in the mitochondria: it's DNA. Mitochondrial DNA helps determine how mitochondria function and can be damaged under stress. Our goal in this proposed work is to determine the role of mitochondrial DNA in mitochondrial dysfunction and its link to their poor trainability. Questions: 1. Are there mitochondrial DNA markers linked to mitochondrial dysfunction and poor exercise trainability in young adults very born preterm? 2. Do mitochondrial DNA in young adults born very preterm respond differently to aerobic exercise training than those born at term? The investigators expect this work will show mitochondrial DNA changes linked to mitochondrial dysfunction and poor trainability, which can be used for future targets to improve health. This work supports AHA mission by helping to identify a marker in individuals born very preterm linked to their higher heart disease risk and death early in life.

NCT ID: NCT06306794 Not yet recruiting - Pain Clinical Trials

Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration

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

The aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration. It is a randomized controlled quasi-experimental design. The study will be conducted in the neonatal intensive care unit of Health Sciences University Bursa High Specialization Training and Research Hospital. The population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups. PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used as a case report form for the collection of the study data. All the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. Standardization will be ensured by intervening in all patients with the same application by the same nurse. During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. The routine aspiration application steps of the unit will be applied to the control group without any intervention.

NCT ID: NCT06302023 Not yet recruiting - Clinical trials for Pregnant Women Diagnosed With Threatened Preterm Labor

Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor

Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm labor The main questions it aims to answer are: - Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor? - How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups - Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day - Group 2 (control) Participant will not need to take a DHA

NCT ID: NCT06265740 Not yet recruiting - Premature Birth Clinical Trials

Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota

PREMABIOTE
Start date: March 2024
Phase: N/A
Study type: Interventional

Objectives: to assess the relevance of the "RiboTaxa" algorithm coupled with neural network learning based on analysis of vaginal microbiota metagenomic sequencing data for predicting prematurity in an identified at-risk population. Study description: Longitudinal follow-up of a cohort of pregnant women, with collection of biological samples, and a posteriori case-control comparison based on the occurrence of an event (premature birth).

NCT ID: NCT06263127 Not yet recruiting - Preterm Infants Clinical Trials

Sensory Motor Interventions on Preterm Infants

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

Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. The objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants.

NCT ID: NCT06262308 Not yet recruiting - Clinical trials for Preterm Birth Complication

Emotional Support for Women Experiencing PPROM

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

Preterm Prelabour Rupture of the Membranes is a pregnancy complication affecting 3% of all pregnancies. Outcomes for both the mother and baby are variable including: preterm delivery, fetal infection, cord prolapse, abruption as well as maternal sepsis and even maternal death. The outcomes are not only variable but the stress and uncertainty can be over a protracted period of time. This is a pilot study that aims to provide personalised psychological intervention at the time of PPROM based on Cognitive Behavioural Principles to see whether this improves psychological outcomes for women.

NCT ID: NCT06259604 Not yet recruiting - Preterm Birth Clinical Trials

Preterm Infant Oral Motor Intervention (PIOMI)

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

The purpose of this research; The aim of this study is to examine the effects of oral motor intervention (PIOMI) and combined kangaroo care applied to preterm babies on weight gain, oral feeding skills, transition to full oral feeding and discharge time.

NCT ID: NCT06246864 Not yet recruiting - Clinical trials for Neonatal Skin Conditions

Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies

Start date: February 5, 2024
Phase: N/A
Study type: Interventional

While medical adhesives provide fixation of devices and catheters in neonatal intensive care, they can cause disruption of skin integrity when removed. Therefore, when detecting medical devices, it is important to choose products that will not harm babies' skin and to use different occlusive dressings (polymer foams, hydrogel dressings, hydrocolloid dressings). This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.

NCT ID: NCT06240715 Not yet recruiting - Preterm Clinical Trials

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm

CORDMILK-PT
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.