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Premature Birth clinical trials

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NCT ID: NCT04972747 Active, not recruiting - Premature Birth Clinical Trials

The Effect of Skin Care Applied With Two Different Oils on Skin Integrity and Growth Parameters in Premature Babies

DEAH
Start date: October 16, 2020
Phase: N/A
Study type: Interventional

As a result of technological advances in the field of newborns, the survival rates of very young babies have increased. With this situation, there was a need to develop new evidence-based application areas in premature babies. Nurses provide evidence-based care in many areas to term and preterm babies in the neonatal intensive care unit. One of these areas is the skin, which is known as 13% of the newborn's body weight and constitutes the largest part of the organism. Before skin care is given, knowing the skin characteristics of the newborn and performing skin care in accordance with these features will provide more benefits for the baby. The skin of newborns is different from adults in terms of both function and function. In addition, skin characteristics of term and preterm babies also differ according to the week of delivery. Skin basically enables the newborn to explore the world by thermoregulation, as a barrier against microorganisms and chemical harmful substances, maintaining fluid-electrolyte balance, vitamin D production, fat storage and sensory-touch. The immature skin of the newborn cannot fully fulfill these functions. In another study conducted between sunflower oil and the control group, it was stated that rash and peeling were less common in the sunflower oil experiment group compared to the control group. As a result, evidence-based knowledge of nurses about neonatal skin care should be increased in neonatal intensive care units, and appropriate nursing care should be given especially to premature newborns who are at risk due to hospitalization. Even if there is no routine procedure in our service, baby oil is massaged during care hours, but there is no study on this. The aim of this study is to contribute to the neonatal skin care literature and to provide appropriate evidence-based care in the service routine.

NCT ID: NCT04835935 Active, not recruiting - Prematurity Clinical Trials

Microbiome, Atopic Disease, Prematurity

MAP
Start date: June 1, 2019
Phase:
Study type: Observational

There is increasing recognition that the microbiome may be important in the development of allergic disease. Asthma is the most prevalent pediatric chronic disease and affects more than 300 million people worldwide. For unclear reasons, those infants born at 34 weeks and earlier are three times as likely to develop asthma. Factors such as formula feeding, C-section delivery and antibiotic exposure may play a role. Recent evidence has identified a "critical window" in early life where gut and breast milk microbial changes are most influential. The investigators propose a novel study to follow a cohort of premature babies in the NICU and after discharge home. The investigators aim to examine whether various exposures of babies in the NICU impact their milk and gut microbiome and lead to asthma and allergies. Our specific aims are: 1. To assess if there is a specific pattern of gut and/or breast milk microbiome over time that is affected by the type of nutrition a baby receives (donor vs maternal vs formula) or other exposures such as antibiotics. 2. Assess whether there are patterns in the microbiome associated with the development of allergic sensitization patterns. 3. Determine if early patterns of the microbiome and allergic sensitization predict allergic conditions (food allergies, allergic rhinitis, eczema, asthma) by 2 years of age. The investigators will recruit approximately 50 subjects born at 34 weeks of gestation or earlier from two local level III NICU. These subjects will be followed over their NICU course with weekly stool, milk feed, and oral saliva collection as well as documentation of relevant events including prenatal history, delivery history, nutrition and breast feeding history and antibiotic courses. Further samples will be collected after discharge at research visits that will take place Rady Children's Hospital until 4-6 years of age. At these visits, standardized allergy questionnaires and a blood allergy panel will be obtained. Together this data will provide a unique opportunity to identify potential shifts in the microbiome associated with nutrition, asthma and allergy in preterm infants. Ultimately, the investigators may be able to discover ways to prevent the development of asthma and allergies during this early window of opportunity.

NCT ID: NCT04826978 Active, not recruiting - Preterm Birth Clinical Trials

Auditory Environment by Parents of Preterm Infants

APPLE
Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

Data on parent-infant physical closeness and infants' auditory environment will be collected among preterm infants when they are at gestational age of 32 to 34 weeks. The follow-up includes eye-tracker test at 7 months of corrected age for face preferences of the infants and simultaneously parents' eye movements and pupil diameter responses. During the second year, the follow up includes MacArthur Communicative Development Inventories (lexical development) at 12 and 24 months of age; language development test (Reynell Developmental Language Scales III) and developmental test (Bayley Scales for Infant development Edition III) at 24 months of corrected age.

NCT ID: NCT04738058 Active, not recruiting - Clinical trials for Intestinal Permeability in Preterm

Influence of Bovine Lactoferrin on Feeding Intolerance and Intestinal Permeability in Preterm Neonates

Start date: December 15, 2020
Phase: Phase 1
Study type: Interventional

Preterm infants are at increased risk of developing feeding intolerance due to functional immaturity of their gastrointestinal tract and may lead to discontinuation of enterak feeding. Lactoferrin promotes the growth of probiotic bacteria, stimulates differntiation and proliferation of enterocytes and expression of intestinal digestive enzymes , lead to improvement of feeding intolerance. So we hypothesized that supplementation of bovine lactoferrin would be benificial on feeding intolerance and decrease intestinal permeability in preterm infants with feeding intolerance.

NCT ID: NCT04723966 Active, not recruiting - TPN in Preterm Clinical Trials

Safety and Efficacy Evaluation of TPN in Preterm Neonates in NICU of Cairo University Children Hospital

Start date: April 7, 2019
Phase:
Study type: Observational

The aim of this work is evaluation of electrolytes and minerals homeostasis and occurrence of complications among preterm babies receiving total parenteral nutrition, and admitted to the neonatal intensive care units of Cairo University Children hospitals.

NCT ID: NCT04718220 Active, not recruiting - Covid19 Clinical Trials

Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19

STOPCOVID19
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk preterm birth, cesarean section, and maternal critical care. This study will examine the factors that impede testing for SARS-CoV-2 (the causative virus among pregnant women), help determine optimal testing strategies by evaluating the necessity of testing for asymptomatic disease in pregnancy, inform prenatal care plans by assessing the full impact of infection, and contribute to a provider's ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.

NCT ID: NCT04678570 Active, not recruiting - Clinical trials for Orogastric Tube Insertion

Pain Perception Associated With Orogastric Tube Insertion in Preterm Infants

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

This study is a randomized controlled experimental study designed to examine the effect of white noise and swaddling methods in reducing the pain caused by orogastric tube insertion in preterm infants. This study is planned to be conducted with 4 groups, consisting of 3 experimental groups and 1 control group. White noise, swaddling method, and white noise + swaddling methods will be the interventions during the study together with the standard care and procedures for the experimental groups, while the control group will only have standard care and procedures during the study.

NCT ID: NCT04675970 Active, not recruiting - Clinical trials for Premature Ovarian Failure

Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy

UB-OVF
Start date: September 1, 2020
Phase:
Study type: Observational

This is a multi-centers of long term safety and efficacy follow up study for patients with premature ovarian failure (the women aged younger than 40 years, who present with amenorrhoea, hypergonadotropic hypogonadism, and infertility) who have been treated with ex vivo gene therapy drug product in Institute of Bio-Stem Cell Rehabilitation UAB - sponsored clinical studies. After completing the parent clinical study (approximately 6 month), eligible subject will be followed for additional 2 years for total of 2 years and 6 month post drug product infusion. No investigation drug product will be administered in the study

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: NCT04617587 Active, not recruiting - Premature Birth Clinical Trials

Novel Epigenetic Biomarker for Prematurity Related Neurodevelopmental Disorders in Childhood

Start date: December 3, 2020
Phase: N/A
Study type: Interventional

Preterms are early exposed to a stressful environment (i.e. excessive sensory stimulation and paucity of parental contact) with subsequent detrimental effects on brain maturation and neurodevelopmental outcomes. In contrast, early interventions seem to reduce stress exposure and promote neurodevelopment. The brain functional plasticity in response to environmental experiences can be partly attributed to changes in DNA methylation. In this context, LINE-1 (L1) promoter (18% of human genome) methylation/demethylation has been associated with L1 somatic mobilization in the brain genomes, contributing to experience-driven brain plasticity; this mechanism being deregulated in important neurological disease. This study aims at identifying and characterizing the role of L1 DNA repeats as a novel biomarker to predict long-term neurodevelopmental outcome in preterm infants. In addition, the study's secondary goal will be to define a preventive approach, based on early intervention strategies, for improving long-term neurodevelopmental outcomes.