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Premature Birth clinical trials

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NCT ID: NCT05308342 Recruiting - Clinical trials for Premature Ovarian Insufficiency

Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

Start date: November 20, 2019
Phase: N/A
Study type: Interventional

This study was a single-center, randomized, controlled prospective study. Those who had premature ovarian failure and who had fertility requirements were enrolled in the study. To determine the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of patients with POI.

NCT ID: NCT05304949 Recruiting - Clinical trials for Retinopathy of Prematurity

Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity

Start date: June 22, 2022
Phase:
Study type: Observational

This study is an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.

NCT ID: NCT05299112 Recruiting - Clinical trials for Nutritional Deficiency

An Exploratory Study of Increased Preterm Arginine INTake (PAINT18)

PAINT18
Start date: December 7, 2021
Phase: N/A
Study type: Interventional

PAINT18 is a nutrition study focusing on the effect of arginine supplementation on immune function in preterm infants. The investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN) formulations on blood arginine levels and the genes that are involved in body nutrition and fighting infection in premature babies. The investigators will also investigate the effect of supplementing arginine on these genes. The investigators will undertake a single centre exploratory physiological study in 24 very premature infants receiving PN. 16 of these infants will be supplemented with arginine. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 30 days of life. The investigators will take blood for analysis at prespecified intervals for RNA sequencing, ammonia and IGF-1 levels. RNA sequencing findings will allow the investigators to describe the effect of arginine on gene activity in preterm infants The investigators hypothesise that arginine supplementation will result in changes in gene expression that are consistent with changes in T-cell function and associated inflammatory pathways.

NCT ID: NCT05282628 Active, not recruiting - Pre-Term Clinical Trials

I-InTERACT Preterm

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

Open pilot of a brief online parenting-skills intervention for young children ages 3-8 who were born very preterm (< 32 weeks gestational age). Parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed pre- and post-intervention 10 weeks later.

NCT ID: NCT05278130 Recruiting - Bacterial Vaginosis Clinical Trials

Serial Screening and Treatment of Bacterial Vaginosis Trial

SECRETIVA
Start date: October 20, 2022
Phase: N/A
Study type: Interventional

The purpose of this investigator-initiated randomized control trial is to determine if bacterial vaginosis infection increases the likelihood of preterm delivery in women with history of preterm delivery. Subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control.

NCT ID: NCT05272956 Recruiting - Premature Birth Clinical Trials

Parental Involvement in Enteral Nutrition in Neonatal Units

PREMALIM
Start date: August 10, 2022
Phase: N/A
Study type: Interventional

- Hypothesis : Bolus feeding of the newborn with a syringe under parents' visual control increases parental presence when compared to enteral feeding with a syringe pump. - Main criteria : Comparison of parental presence (mean time in hours) between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump.

NCT ID: NCT05267717 Recruiting - Preterm Birth Clinical Trials

Impact of Pessary Treatment on Cervical Stiffness Measurement and Birth Outcomes in Patients at Risk for Preterm Birth

Start date: November 23, 2021
Phase:
Study type: Observational

Background: A preterm birth remain a worldwide important socioeconomic burden since prematurity has been consistently implicated in a wide range of health medical problems affecting newborn child and contributed in up to more than a half of overall perinatal mortality. Several studies have shown a significant therapeutic benefit as a result of an antenatal cervical pessary use in a high-risk preterm birth group of pregnant women. However the underlying mechanism by which pessary can reduce a risk of a preterm birth remain elusive. The study aims to quantitatively assess an ectocervical stiffness in a normal and in a treated with a pessary high-risk preterm birth pregnancy. Methods: A prospective, non-interventional, post-market, monocentric, longitudinal, cohort study in a obstetric-led tertiary maternity teaching hospital to determine ectocervical stiffness and its changes measured prior and after the placement of a pessary, and the correlation of measured cervical stiffness or its changes with birth outcome in a high-risk preterm birth pregnant women indicated for cervical pessary. A cervical stiffness measured with Pregnolia system as the Cervical Stiffness Index (CSI, in mbar) will be a primary, whilst patient delivery data (gestational age, mode of delivery and complications) will be a secondary endpoint. In this pilot study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) completed the study; Pessary cohort: 60 (up to 71 recruited), normal cohort: 60 (up to 71 recruited). Discussion: We hypothesize than the study will substantially improve our knowledge about cervical incontinency and preterm labour pathophysiology. We hope that our investigation will be able to elucidate ectocervical stiffness phenomenon both in high-risk preterm birth and in normal pregnant control, as well as the impact of cervical pessary use on a the CSI values.

NCT ID: NCT05266664 Recruiting - Preterm Clinical Trials

Preterm Immune System Development and Response to Immunization

PRIMI
Start date: December 8, 2022
Phase:
Study type: Observational

In this study the response to vaccination and development of the immune system in very preterm infants upon the current vaccination schedule will be compared to healthy term infants.

NCT ID: NCT05265195 Recruiting - Communication Clinical Trials

PeriviAble DeLiveries: ALIgning PArental aNd PhysiCian PrioritiEs (ALLIANCE)

ALLIANCE
Start date: May 31, 2022
Phase:
Study type: Observational

Background: There is significant variation in how clinicians currently present information to parents in periviable labour. Whilst each conversation with an individual set of parents will vary, the current level of variation is extreme. In collaborative discussions with the neonatal parental advisory group whilst designing this project, parents reported numerous experiences of significant variation in practice between clinicians in relation to periviable delivery management. There is a pressing issue of injustice here as the hospital or clinician the parent presents to in labour should not restrict their access to information and options for management at delivery. Parents should be empowered and engaged in making an individualised decision for their infant. However, this is not possible if information is not accurately presented to them. There is a gap in knowledge about what information is vital to include in periviable decision-making conversations between parents and healthcare professionals. This study aims to address this important gap in knowledge. Research Question: How can information sharing and decision-making conversations between healthcare professionals and parents prior to periviable birth be improved? Research Aims: 1. To gain understanding of current UK-wide antenatal optimisation practices for infants born at periviable gestations. 2. To establish an evidence-based conversational structure for pre-delivery periviable decision-making discussions, and a prioritised set of key discussion topics derived from parental consensus and clinician input. 3. To develop a set of parent and clinician derived recommendations to improve pre-delivery periviable decision-making conversations. Methodology: The study would progress along the following structure: 1. Literature Review of literature related to how and what information is presented to parents facing periviable labour by healthcare professionals. 2. Semi-structured interviews with clinicians and parents. The aim will be to determine an evidence-based set of priorities for each group and identify the differences in priorities and barriers that exist in communication between parents and clinicians. 3. National Evaluation of current periviable management practices across the UK. This will benchmark and expose variation in current practice. 4. Analysis of pre-delivery periviable conversations. 5. Focus groups with parents and clinicians to consolidate and stratify key priority themes for periviable decision-making conversations and assess acceptability of developing parent-centred periviable delivery resources. 6. Parent survey of parent-assessed long-term outcomes for periviable delivery survivors. Impact and Dissemination: This study will investigate the key topic areas and conversational structure of pre-delivery periviable decision-making conversations, aiming to provide evidence-based recommendations for improvement.

NCT ID: NCT05265143 Recruiting - Clinical trials for Enteral Feeding Intolerance

Comparision of Two Different Feeding Method in Preterms

Start date: January 1, 2015
Phase: N/A
Study type: Interventional

achievement of optimal postnatal growth by adequate enteral nutrition in critically ill preterm infants is a challenge of NICU. signs like abdominal distension, reflux, vomiting, nec is a factors of discontinuing fedding in preterm. this factors plays a role in decisions about which method of gavage feeding is adopted. we compare two different feeding method to achive less fedding tolerence.