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Premature Birth clinical trials

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NCT ID: NCT03504670 Completed - Labor Induction Clinical Trials

Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial

PITA
Start date: November 14, 2018
Phase: N/A
Study type: Interventional

Artificial rupture of membranes (amniotomy) is a commonly used technique to safely induce and augment labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients (≥37 weeks' gestation). The utility of amniotomy in preterm patients (<37 weeks' gestation) undergoing medically-indicated induction of labor is unknown. However, it remains a commonly used strategy. We will conduct a trial comparing early amniotomy versus late amniotomy during medically-indicated induction of labor between 23.0 and 35.6 weeks gestation. Women will be randomized to early or late amniotomy after the obstetrician has decided to induce labor for a medical indication. We hypothesize that more women in the early amniotomy group will require cesarean delivery, and the duration of labor will increase in the early amniotomy group.

NCT ID: NCT03504215 Completed - Clinical trials for Prematurity; Extreme

Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health.

Start date: March 2, 2018
Phase: N/A
Study type: Interventional

In spite of advances in neonatal intensive care allowing the first generation survivors of extreme prematurity to now reach young adulthood, these individuals present with reduced exercise capacity; a strong predictor of later chronic disease and mortality. The reason why individuals born preterm have exercise limitation remains unclear and may be a consequence of impact of preterm birth and associated neonatal difficulties on the development of organs important for exercise, namely the lungs, the heart, the vessels (which bring blood and oxygen to the muscles) and the muscles. It is well known that exercise benefits overall health in at-risk as well diseased populations. However, whether exercise training can improve fitness in young adults born preterm was not demonstrated and whether the cardiovascular, pulmonary and muscle impairments associated with preterm birth are reversible through exercise intervention in young adulthood is unknown.

NCT ID: NCT03501030 Recruiting - Preterm Birth Clinical Trials

Activity Restriction for Women With Arrested Preterm Labor

Start date: November 25, 2019
Phase: N/A
Study type: Interventional

to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.

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: NCT03493113 Completed - Clinical trials for Transient Hypothyroxinemia of Prematurity

EEG Alterations in Preterm Infants With Thyroid Dysfunction

EEG-THOP
Start date: October 2011
Phase:
Study type: Observational

The aim of this study is to investigate differences in electroencephalography (EEG) evolution between preterm infants with and without transient hypothyroxinemia of prematurity (THOP) in order to find differences in the interburst interval and the background pattern and in the maturation of the sleep-wake cycle.

NCT ID: NCT03491826 Completed - Clinical trials for Premature Rupture of Membrane

Fetal and Maternal Outcome in Preterm Premature Rupture of Membranes (PPROM)

Start date: January 2010
Phase:
Study type: Observational

The aim of this study is to compare fetal and maternal outcome in cases of PPROM before 34 weeks versus after 34 weeks.

NCT ID: NCT03480139 Completed - Pregnancy Clinical Trials

Biomarkers in Obstetrical Complications

Start date: February 28, 2018
Phase:
Study type: Observational

Objective: To study the natural history of normal pregnancy and the most frequent pregnancy complications responsible for the excessive rate of perinatal morbidity and mortality, in order to develop models to predict the occurrence of these complications of pregnancy at the earliest possible time. The study focuses on the prediction of preterm labor with intact membranes, preterm prelabor rupture of membranes (PROM), preeclampsia, small for gestational age, gestational diabetes, and fetal death. These complications account for a minimum of $30 billion annually in the US alone. Study population: A cohort of pregnant women seeking care at the prenatal clinic of the Perinatology Research Branch in Detroit, Michigan. Design: A prospective observational cohort study of the natural history of women with a normal pregnancy, a history of adverse outcome, or those with a complication in the index pregnancy; therefore, this study will include nulliparous and parous women. Data will be collected at the time of clinic visits and will include interviews, clinical measurements, and ultrasound studies. We will assemble a biorepository of maternal biological fluids (blood, urine, saliva, cervicovaginal fluid, gingival crevicular fluid, swabs to characterize microbiota, amniotic fluid when a clinically indicated amniocentesis is performed). Placentas will be collected at the time of delivery as well as umbilical blood, and swabs to characterize the neonatal microbiota. We will use a retrospective case control and case-cohort design to generate models for the prediction of the most common pregnancy complications. These models will be developed by classifying obstetrical complications according to clinical presentation and histologic placental lesions. Models will be developed and subsequently validated in an independent cohort. Outcome measures: The goal is to develop sensitive, specific, and parsimonious predictive models to identify the patients at risk for developing complications of pregnancy using a combination of clinical and biological markers (biochemical and biophysical).

NCT ID: NCT03479515 Active, not recruiting - Prematurity Clinical Trials

Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes

Start date: July 20, 2018
Phase:
Study type: Observational

The overall objective of the proposal is to evaluate the ability of ultrasound to predict the body composition of toddlers in the outpatient clinical setting and to evaluate the relationship between body composition and neurodevelopment.

NCT ID: NCT03476980 Recruiting - Clinical trials for Neurodevelopmental Abnormality

Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)

PREMOD2FU
Start date: July 6, 2019
Phase: N/A
Study type: Interventional

An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.

NCT ID: NCT03473210 Completed - Clinical trials for Preterm Premature Rupture of Membrane

The Value of Amniopatch in Preterm Premature Rupture of Membranes

Start date: October 1, 2016
Phase: N/A
Study type: Interventional

A randomized controlled trial that involved 100 women diagnosed with PPROM between 24 and 34 weeks of gestational age. Participants were randomized equally into 2 groups. Group I in which amniopatch was done (an amnioinfusion of platelet concentrate followed by fresh frozen plasma in addition to the routine management used in the control group. Group II were treated with routine management including antibiotics and corticosteroids