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Premature Birth clinical trials

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NCT ID: NCT04367181 Recruiting - Premature Birth Clinical Trials

DCS Study in Extremely Premature Newborns

Start date: March 15, 2019
Phase: N/A
Study type: Interventional

We are attempting to improve the cerebral monitoring of extremely low gestational age (ELGA) infants, such that in the future, real-time monitoring will be possible, to aid clinicians in their management of these infants. We wish to establish a new NIRS device, diffuse correlation spectroscopy (DCS), as a safe, noninvasive and informative bedside tool for assessing and monitoring brain health in ELGA infants during the first few days of life. It is hoped that this method will provide detailed information on changes in oxygen consumption and metabolism, and cerebral perfusion. This technique will have wide applicability, but for this research study we wish to focus on the effect of blood flow instabilities, intermittent hypotension and hypoxic episodes, pressure passive CBF periods, and hypoperfusion on the preterm brain during the first days of life, and their relationship with incidence of intraventricular hemorrhage (IVH). We aim to recruit 100 premature infants to obtain data to: 1. Test the feasibility of NIRS-DCS to monitor cerebral activity, perfusion and oxygen consumption in extremely premature infants during the first week of life. 2. To assess if these baseline values are impacted by intermittent hypoxic episodes. 3. To assess if cerebral blood flow disturbances correlate with incidence of intraventricular hemorrhage. 4. Correlate the NIRS-DCS findings with clinical outcome at hospital discharge.

NCT ID: NCT04359134 Recruiting - Clinical trials for Respiratory Distress Syndrome in Premature Infant

Combined Lung Ultrasounds and Transthoracic Electrical Bioimpedance in Preterm Infants With Respiratory Distress.

Start date: March 10, 2020
Phase:
Study type: Observational

Respiratory distress syndrome (RDS) is among the most common complications of preterm birth, and typically becomes manifested soon after birth. A failure of the rapid reuptake of fetal lung fluids after birth, with subsequent liquid retention in the alveolar space, together with the deficit of surfactant proteins ensuing from lung immaturity represent the leading mechanisms for the development of RDS, which may require different levels of respiratory support. An increasingly used method for the evaluation of the neonatal lung is pulmonary ultrasound, which allows assessing alveolar fluids and other pathological conditions in a non-invasive manner, and has been shown to predict the need for respiratory support and for surfactant administration in preterm infants with RDS. However, this method requires specific training, is operator-dependent and does not provide a trend able assessment over time. Transthoracic electrical bioimpedance (TEB) allows continuous and non-invasive monitoring of static and dynamic thoracic fluids. It has been recently introduced in neonatal clinical practice to assess such hemodynamic parameters as cardiac output and also quantifies static thoracic fluids contents (TFC). This method provides continuous and non-operator dependent data on the pulmonary fluid status over time and does not require specific training. The combination of lung ultrasound with TEB could open to new diagnostic and prognostic perspectives in preterm infants with RDS.

NCT ID: NCT04335240 Recruiting - Music Therapy Clinical Trials

Premature Family Music Therapy Intervention (PFMI)

PFMI
Start date: April 30, 2021
Phase: N/A
Study type: Interventional

The music therapy intervention it is dedicated to premature baby and their family at the Neonatal Intensive Care Unit (NICU)of the Woman-Child department "Hospital Del Ponte". In NICU an integrated psychological and music therapeutic protocol has been structured. The protocol aims to limit or overcome long-term developmental morbidities, promote parenting and attachment bond in preterm infants. Protocol is named "Premature family music therapy intervention (PFMI): an Italian protocol to support parenting, attachment bond and preterm development". The methodologies will provide early intervention from the first days of hospitalization in NICU and use music therapy sessions "active" (chant parental, live music and lullaby) and "receptive" (listening to recorded tracks). Such therapy becomes a support for the born prematurely and her parents during hospitalization and after discharge. The music therapy accompanies the newborn and his parents during the hospitalization and focuses its attention on the emotional-relational care, according to the different needs of babies and parents. This protocol it is a Family Centered Care Music Therapy Intervention.

NCT ID: NCT04304846 Recruiting - Preterm Birth Clinical Trials

AttachMent Preterm in the Loire Infant Follow-up Team

AMPLIFy
Start date: January 7, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to describe the attachment representations of children born prematurely at age 3 and 5 with regard to their neurocognitive and behavioral development.

NCT ID: NCT04300322 Recruiting - Preterm Birth Clinical Trials

Pessary Versus Progesterone in Singletons

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

This study compares the effectiveness of cervical pessary to vaginal progesterone for prevention of preterm birth in women with singleton pregnancies and a cervix ≤25 mm. Participants will be randomly assigned in a 1:1 ratio to receive cervical pessary or vaginal progesterone.

NCT ID: NCT04293939 Recruiting - Preterm Birth Clinical Trials

Skin-to-skin Contact in Neonatal Intensive Care Unit (NICU), Caregiving Touch and Neural Correlates of Slow Stroking Touch in Preterm Infants

Start date: December 2, 2019
Phase:
Study type: Observational

Preterm (PT) infants spend their first weeks of life in Neonatal Intensive Care Unit (NICU) where receive little affective physical contact, which plays a crucial role in brain development. Evidence indicates that skin-to-skin contact (SSC) has a positive effect on infants' neurophysiological and behavioral adjustment to postnatal life. Moreover, caregiving touch during early interactions is related to sensitive caregiving behavior, which in turn is associated with brain connectivity in full-term (FT) infants. Despite the importance of both SSC and caregiving touch for infant development little is known about the neural correlates of early physical contact in PT infants. Using MRI the project aims to investigate the association between brain responses to gentle skin stroking at 2 months examining the effects of: (1) the birth status (PT vs. FT); (2) the duration of SSC in NICU; (3) the caregiving touch in the home environment and during mother-infant interaction. The investigators hypothesized: (1) differences in the brain responses in the above mentioned ROIs to gentle skin stroking, a type of tactile stimulus associated with affectionate touch and social interaction26, between FT infants and PT infants: (2) that above mentioned putative differences would be mitigate by duration of SSC during the NICU in PT infants; (3) an association between CT/sensitive caregiving behaviors both in the home environment and during face-to-face interaction and brain response in the above mentioned ROIs to gentle skin stroking in PT and FT infants.

NCT ID: NCT04287504 Recruiting - Preterm Birth Clinical Trials

Point-of-care Tests for Bacterial Vaginosis and Candidosis

Start date: February 14, 2020
Phase:
Study type: Observational

Vaginal infection in early pregnancy is associated with an increased risk of spontaneous preterm delivery and late miscarriage. Most studies presume that vaginal infections are responsible for up to 40% of preterm birth. Although the causative microorganisms of vaginal infections are manifold, the three pathogens most commonly associated with vaginal infections are Gardnerella vaginalis, Candida albicans and Trichomonas vaginalis. The aim of this prospective study is the validation of the point-of-care tests OSOM BVBLUE for bacterial vaginosis and SavvyCheck Vaginal Yeast Test for candidosis in comparison to Gram stain.

NCT ID: NCT04284280 Recruiting - Clinical trials for Necrotizing Enterocolitis

Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants

Start date: February 15, 2020
Phase: N/A
Study type: Interventional

The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.

NCT ID: NCT04270734 Recruiting - EEG Clinical Trials

Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood

PremaTempo
Start date: February 1, 2020
Phase: N/A
Study type: Interventional

Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy.

NCT ID: NCT04246333 Recruiting - Premature Birth Clinical Trials

Duodenal Feeds in Very Low Birth Weight Infants

Start date: August 7, 2020
Phase: N/A
Study type: Interventional

Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support. These infants are at increased risk for gastroesophageal reflux and aspiration which may exacerbate lung injury. Transpyloric feeds, specifically duodenal feeds, may be used to bypass the stomach and directly feed the duodenum decreasing the amount of gastric reflux contributing to aspiration. Duodenal feeds are equivalent to gastric feeds with regards to nutritional outcomes, and have been shown to decrease events of apnea and bradycardia in premature infants. This study will evaluate the feasibility and safety of duodenal feeds in premature infants. The hypothesis is that duodenal feeds may be safely and successfully performed in premature very low birth weight infants.