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Premature Birth clinical trials

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NCT ID: NCT03673566 Withdrawn - Stress Clinical Trials

Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO

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

This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. Clinicians will be asked to follow their current standard of care practices with the aid of this technology. About half of participants will receive care in NICU rooms with the Dashboard installed while the other half will receive standard care without the Dashboard.

NCT ID: NCT03630367 Withdrawn - Premature Birth Clinical Trials

Effects of L-Carnitine Supplementation on Respiratory Distress Syndrome

Start date: October 3, 2018
Phase: Phase 4
Study type: Interventional

The aim of the present study was to investigate the efficacy of L-carnitine therapy on the occurrence and prognosis of respiratory distress syndrome

NCT ID: NCT03561935 Withdrawn - Clinical trials for Premature Ventricular Complex

Beta-blocker vs. Ic Antiarrhythmic Drug for PVC

Start date: June 2015
Phase: N/A
Study type: Interventional

The standard medical therapy of idiopathic premature ventricular complex consists of beta blocker and Ic antiarrhythmic agent. However, the difference in the efficacy of two drugs has not been well investigated. This prospective randomized study aimed to compare the efficacy of beta-blocker and Ic antiarrhythmic agent in the treatment of symptomatic patients with idiopathic premature ventricular complex.

NCT ID: NCT03540225 Withdrawn - Premature Birth Clinical Trials

Vaginal Progesterone for the Prevention of Preterm Birth in Twins

POPPET
Start date: April 2020
Phase: Phase 3
Study type: Interventional

This trial is a randomised, multi-centre, 2 x 2 factorial designed pilot trial with two factors of 200mg vs. 400mg progesterone self-administered daily from 11-14 weeks' gestation vs. 20-24 weeks' gestation, to compare the median gestational age (in days) at delivery between the comparison groups.

NCT ID: NCT03497793 Withdrawn - Premature Birth Clinical Trials

A Feasibility Study of the SNUBY®, a Skin-to-skin Garment, in the Preterm Infant

Preterm SNUBY®
Start date: December 2021
Phase: N/A
Study type: Interventional

Skin-to-skin care (placing the nappy-clad baby on the mother's bare chest and draping both in a blanket) is known to benefit both baby and mother. Benefits to the baby include warmth, reduced crying, and stabilisation of heart rate, breathing and blood sugar, and promotion of breastfeeding while simultaneously reduces mother's anxiety, improves bonding, and increases breastmilk production. Although these benefits are even more pronounced for preterm, studies show most preterm babies do not receive adequate skin-to-skin care due to fears such as dislodging intravenous lines, ventilation tubes, monitor wires and concerns about safety and privacy. Measures are therefore required to increase maternal confidence and awareness and facilitate skin-to-skin care for preterm infants. SNUBY® (SNUggle baBY) is a purpose-built garment for facilitation of skin-to-skin care in preterm infants. It is made of comfortable, breathable bamboo fabric with an attractive appearance such that it can be worn as a normal garment. In addition, it has distinctive features that allow the baby to be placed in a specially designed pouch, in direct contact with the mother's skin, with supports for lines and tubes that may be attached to the baby. Although many garments are commercially available for mothers to carry babies, no such specially designed garment has ever been tested scientifically and none are specifically designed for preterm babies. In this observational study, the investigators will initially test the feasibility of using the SNUBY® in preterm infants by inviting five mothers-preterm infant pairs, with mother's written informed consent, to use the garment under direct supervision. Following this, the investigators will analyse the safety and acceptability of using it on a larger scale to facilitate skin-to-skin care in preterm babies. The investigators will gather information on the staff and mothers' knowledge of skin-to-skin care and their experience of using SNUBY®.

NCT ID: NCT03447405 Withdrawn - Premature Birth Clinical Trials

Dino Egg in Neonatal Intensive Care Unit

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Dino EGG mother's voice exposure and multisensory processing in Neonatal Intensive Care Unit infants. This is a 2 phase prospective comparative effectiveness trial of our parents' voice intervention with 290 hospitalized preterm infants. As a part of a previous project, an early technology development award from the Nationwide Children's Hospital (NCH) Technology Office allowed us to develop 10 functioning prototypes of the DINO EGG speakers, a NICU-safe and developmentally appropriate music player that delivers parent's voice to the bedside of NICU infants. The device passed NCH NICU-safe products committee and has been used in the clinical setting delivering clinical music therapy services (available at bedside to play parents' voice). The first phase of the current study is to test an updated prototype version of the device that replicates a previously FDA (and NCH NICU-safe products) proved device called Pacifier Activated Lullaby (PAL), used and described in IRB15-01035, but being discontinued by the company. The discontinuation is not due to safety or health benefits concerns. Therefore, no device available on the market currently exists to accomplish NICU parents' voice delivery in a consistent and safe manner, the investigators modified a 510K-approved feeding device that is no longer available and whose intellectual property rights have expired. The device's air displacement sensor, which fits into a standard NICU pacifier, allowed the investigators to deliver processed and developmentally appropriate recordings of parent's voice, contingent upon the infant producing effort to receive it. Intellectual property rights were filed for the modifications and use process through the technology transfer and legal office at NCH. Therefore, phase I will test the usability of the device (safety for the NICU was confirmed), not the effectiveness of the parents' voice delivery for the infant. Parent and nursing questionnaires about the importance of the device availability and its usability will be collected from parents and Registered Nurse (RN) staff that choose to provide the feedback.

NCT ID: NCT03443154 Withdrawn - Infection Clinical Trials

VF Test for Prediction of Extremely PTB After Cerclage

Start date: June 2018
Phase:
Study type: Observational

The purpose of this research study is to determine if a vaginal fluid (VF) test can predict very early preterm birth in patients who are scheduled to have an exam indicated cerclage for severe cervical shortening. Prior to participants undergoing a scheduled amniocentesis two swabs to collect vaginal secretions for the VF tests will be done. During the amniocentesis your doctor will remove amniotic fluid as part of the routine clinical care. From that fluid sample, the study will use less than a quarter teaspoon for the amniotic fluid study test (AF test). Data regarding maternal and birth outcomes will be collected by medical record review.

NCT ID: NCT03340103 Withdrawn - Clinical trials for Antioxidant Role of the Lutein in Preterm Newborn

Early Administration of the Lutein/Zeaxanthin in Premature Newborns

Start date: October 11, 2018
Phase: N/A
Study type: Interventional

Premature birth is the most common cause of mortality, morbidity and disability. Premature infants have a higher risk of developing damage in the eyes (retinopathy of prematurity ROP), in the central nervous system (intraventricular hemorrhage IVH), in the lungs (bronchial pulmonary dysplasia BPD), in the gut (NEC) and infections. Oxidative stress has been implicated in various capacities, in the etiology of these conditions. Lutein and Zeaxanthin are powerful anti-oxidants and commonly assimilated with different foods. Lutein and Zeaxanthin are present at level of umbilical cord, in the breast milk (particularly in colostrum) and pass the placental barrier. Concerning supplementations, the lutein presents, for its specific characteristics, a high bioavailability after oral administration. In the last few years, there have been more and more studies which have shown that lutein could constitute a valid and important preventive and protective factor against certain diseases related to oxidative stress. The preparations of lutein and zeaxanthin have never pointed out in the human being (included in the term newborn) adverse or toxic effects. This spontaneous / non-commercial pilot study involves the administration of a dietary supplement containing lutein / zeaxanthin, because the healthcare structures need to identify a natural antioxidant product that can reduce the incidence of serious diseases related to oxidative stress in the perinatal period. This study aims to evaluate if the administration of lutein in watery solution will reduce the rate of free radicals in preterm infants.

NCT ID: NCT03141736 Withdrawn - Preterm Birth Clinical Trials

Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B)

Start date: November 19, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care reduces the incidence of moderate (32-36° C) or severe (<32.0° C) hypothermia in preterm infants ≥ 32 to 36 6/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.

NCT ID: NCT03122704 Withdrawn - Preterm Labor Clinical Trials

Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF

Start date: October 2015
Phase: N/A
Study type: Interventional

This is a cross - sectional study to determine the prevalence of GBS infection and associated factors in preterm labor women conceived through ART. 221 subjects will be involved.