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Premature Birth clinical trials

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NCT ID: NCT05334264 Recruiting - Preterm Birth Clinical Trials

Prophylactic Cervical Cerclage in Twin Pregnancies With Non-shortened Cervix

Start date: December 20, 2021
Phase: N/A
Study type: Interventional

This randomized controlled trial is aimed to assess the protective value of prophylactic cervical cerclage against preterm birth in twin pregnancies with history of one or more preterm births without having cervical shortening in the current pregnancy.

NCT ID: NCT05325177 Recruiting - Clinical trials for Patent Ductus Arteriosus After Premature Birth

PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.

Start date: June 1, 2022
Phase: Phase 4
Study type: Interventional

Babies who are born very prematurely are often born with murmurs in the heart. In preterm babies, one of the most common causes of murmur is the presence of a PDA. This is the persistence of a connection that normally exists in the baby before it is born, connecting between the major blood vessels that leave the heart. In term babies, this channel closes shortly after birth when normal adult circulation is achieved. However, in preterm babies, the PDA can remain open, which can lead to multiple problems in the baby. Our current standard of treatment in the Neonatal Intensive Care Unit (NICU) is to perform cardiac ultrasound (echocardiogram) in all babies less than 29 weeks gestation to diagnose the presence of hsPDA. We also use an echocardiogram to follow the PDA until complete closure. If present, the standard treatment in the NICU is to give medication, usually Ibuprofen, a non-steroidal anti-inflammatory drugs (NSAID), to close the PDA. Near-infrared spectroscopy (NIRS) is a new type of device to detect oxygenated blood supply to the brain, kidney, and abdominal regions. This device is used to assess the effects of Ibuprofen on oxygen supply to these three regions.

NCT ID: NCT05319158 Recruiting - Premature Birth Clinical Trials

The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.

MIT-PB
Start date: April 30, 2022
Phase: N/A
Study type: Interventional

This study aims to assess the effect of a parent-administered intervention program based on MIT-PB in preterm with abnormal general movements during the preterm period. We will describe the short and long-term differences between infants exposed to MIT-PB and infants who follow current standard care.

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: 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.