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Preterm Birth clinical trials

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NCT ID: NCT04372953 Recruiting - Preterm Birth Clinical Trials

Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).

POLAR
Start date: May 4, 2021
Phase: N/A
Study type: Interventional

Premature babies often need help immediately after birth to open their lungs to air, start breathing and keep their hearts beating. Opening their lungs can be difficult, and once open the under-developed lungs of premature babies will often collapse again between each breath. To prevent this nearly all premature babies receive some form of mechanical respiratory support to aid breathing. Common to all types of respiratory support is the delivery of a treatment called positive end-expiratory pressure, or PEEP. PEEP gives air, or a mixture of air and oxygen, to the lung between each breath to keep the lungs open and stop them collapsing. Currently, clinicians do not have enough evidence on the right amount, or level, of PEEP to give at birth. As a result, doctors around the world give different amounts (or levels) of PEEP to premature babies at birth. In this study, the Investigators will look at 2 different approaches to PEEP to help premature babies during their first breaths at birth. At the moment, the Investigators do not know if one is better than the other. One is to give the same PEEP level to the lungs. The others is to give a high PEEP level at birth when the lungs are hardest to open and then decrease the PEEP later once the lungs are opened and the baby is breathing. Very premature babies have a risk of long-term lung disease (chronic lung disease). The more breathing support a premature baby needs, the more likely the risk of developing chronic lung disease. The Investigators want to find out whether one method of opening the baby's lungs at birth results in them needing less breathing support. This research has been initiated by a group of doctors from Australia, the Netherlands and the USA, all who look after premature babies.

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: NCT04182503 Recruiting - Preterm Birth Clinical Trials

Environmental Factors and Embryonic Development Project

EFED
Start date: August 12, 2019
Phase:
Study type: Observational

The Environmental Factors and Embryonic Development Project was set up to investigate environmental exposures and behavioral factors responsible for embryonic dysplasia and gestational complications in pregnant women.

NCT ID: NCT04165252 Recruiting - Preterm Birth Clinical Trials

Vaginal, Placental and Neonatal Buccal Mycobiota and Microbiome in Preterm Birth

Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

Microbiota contributes to the immunological, hormonal and metabolic homeostasis of the host. As in all natural orifices in the body, there is also a microbiota and mycobiota specific to the vagina. On the other hand, the sonographic short cervix in the second trimester of pregnancy is associated with preterm delivery, which may be an important cause of mortality and morbidity in the neonatal period. American Society of Obstetricians and Gynecologists (ACOG), British Royal Society of Obstetricians and Gynecologists (RCOG) and the American Society of Maternal Fetal Medicine (SMFM) suggest that the measurement of transvaginal sonographic cervical length at 20-24 gestational weeks for the screening of preterm birth. The aforementioned associations also recommend the use of progesterone in the treatment of women who diagnosed with short cervix by transvaginal ultrasonography due to the fact that progesterone is an effective medication in the prevention of preterm birth (Grade B). Previous vaginal microbiota studies have shown that some bacterial species such as Lactobacillus insers cause a predisposition to premature labor in women with a short cervix. However, the prominent lack in these studies is that the eukaryotic fungi in abundant vaginal flora have not been evaluated. On the other hand, it was already shown that progesterone treatment is able to prevent only 45% preterm birth in women with short cervical length. This observational prospective study thus aims to evaluate the variety of microbiota and/or mycobiota in pregnancies resulting in preterm birth and those who give birth at term. Although women with short cervical length receive progesterone regularly from the second trimester, the preterm birth may occur. In this study, the investigators also aim to evaluate the patterns of microbiota and mycobiota from vaginal swabs of women who had preterm birth with short cervical length and postpartum swabs of the placenta and fetal oral cavity.

NCT ID: NCT04147117 Recruiting - Preterm Birth Clinical Trials

Cervical Pessary to Prevent Preterm Singleton Birth in High Risk Population

Start date: October 25, 2017
Phase: N/A
Study type: Interventional

DESIGN: Observational prospective study. INCLUSION CRITERIA: All women are 18 years old of age or older with high risk for preterm birth, based on clinical history, and between 18.0 weeks and 23.6 weeks of pregnancy. SAMPLE SIZE: 214 asymptomatic high risk pregnant women. METHODOLOGY: Patient selection, obtaining of informed consent, randomization for cervical placement of pessary. Current follow-up until delivery. Pessary is removed at 37 week or before in some specific situations. MAIN OUTCOME: sPTB <370 weeks of gestation. SECONDARY OUTCOMES: Pregnancy outcomes and a neonatal composite morbidity. EXPECTED RESULTS: Cervical pessary reduces sPB below 37 weeks in high risk of preterm birth population.

NCT ID: NCT04140812 Recruiting - Preterm Birth Clinical Trials

Stratifying Risk for Intracerebral Haemorrhage

NEW_STRATEGI
Start date: October 21, 2019
Phase: N/A
Study type: Interventional

This study aims to investigates the role of gestational age on the prevalence of coagulation factors and components of the complement system in preterm- (≤32+0 weeks) and term neonates (≥37+0 weeks) and their role for the development of brain hemorrhage.

NCT ID: NCT04130165 Recruiting - Preterm Birth Clinical Trials

Matching Donor Human Milk On Maternal Secretor Status (MMOMSS) Study

MMOMSS
Start date: May 29, 2023
Phase: N/A
Study type: Interventional

This study will evaluate the impact of matching donor human milk to the maternal secretor status of very preterm infants (<34 weeks gestation) on the gut microbiome. Half of enrolled infants will receive donor human milk which is matched their mother's secretor status and half will receive standard (unmatched) donor human milk, which is standard care in the neonatal intensive care unit.