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Premature Birth clinical trials

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NCT ID: NCT04093492 Completed - Premature Birth Clinical Trials

Preemie Prep For Parents (P3): Home Antenatal Prematurity Education

Start date: February 3, 2020
Phase: N/A
Study type: Interventional

The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners. The study is a randomized controlled trial (RCT) comparing knowledge and preparedness for decision making between a group receiving the P3 texts and videos and a group receiving links to American College of Obstetricians and Gynecologists (ACOG) prematurity patient education handouts.

NCT ID: NCT04092127 Completed - Clinical trials for Retinopathy of Prematurity

Pain of Premature Babies and RetCam (DOLICAM)

DOLICAM
Start date: November 12, 2019
Phase:
Study type: Observational

It is a single-center prospective observational descriptive study. studied population is premature infants, hospitalized in the neonatology department of the University Hospital of Grenoble and for whom the RetCam examination is planned for screening for retinopathy of prematurity if they are at risk (prematurity <32 weeks). To measure their pain during the examination, it will be a matter of filming the face of the child for 15 seconds before the examination, then 2 times 30 seconds at two distinct times. The PIPP (Premature Infant Pain Profile) score includes a percentage of time on these 30 seconds where 3 items are found modified and a monitoring of heart rate and oxygen saturation.This time calculation can not be done live and requires video recording of the child's face during the exam. The statistical analyzes will be adjusted for sex, gestational age at birth, weight, and pain from birth (determined by the number of doses of level 1 analgesics received by the baby and the number of days (from birth to to the RetCam examination) when the baby received > level 1 analgesics).

NCT ID: NCT04086095 Completed - Clinical trials for Respiratory Distress Syndrome in Premature Infant

Feasibility Study - Neofact

Start date: May 13, 2019
Phase: N/A
Study type: Interventional

For therapy of respiratory distress syndrome (RDS) in premature babies, there are several established options. An important therapeutic aspect is the tracheal administration of exogenous surfactant into the child's lung. In the recent years, several methods have been developed. The methods differ in the selected ventilation mode (intubation with mechanical ventilation vs. Continous Positive Airway Pressure (CPAP)-supported spontaneous breathing) and in the way in which the application of surfactant is technically conducted (via endotracheal tube, endotracheal catheter or nebulization). In selection of ventilation technique, there is an upcoming trend towards less invasive respiratory support via CPAP. While this may increase the rate of complications on the one side (i.e. pneumothorax), it shows much lower oxygen demand and a shorter need for mechanical ventilation on the other side. In the selection of the administration technique, different methods were repeatedly developed to adapt the surfactant administration to the CPAP therapy. In this study, a newly developed and in the European Community now certified (CE-Mark) application aid (Neofact) will be tested for the first time on preterm infants, to verify the feasibility.

NCT ID: NCT04085354 Completed - Clinical trials for Premature Ejaculation

Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation

PE
Start date: February 10, 2019
Phase: Phase 3
Study type: Interventional

This study will aim to assess of the clinical efficacy and safety of dapoxetine, combined dapoxetine with folic acid and combined dapoxetine with vitamin B12 in treatment of patients with premature ejaculation: A randomized placebo-controlled clinical trial.

NCT ID: NCT04077944 Completed - Clinical trials for Preterm Rupture of Membranes

Trace Elements and Heavy Metals at PPROM

metals&PROM
Start date: August 29, 2018
Phase:
Study type: Observational

Objectives: To evaluate maternal serum trace elements and heavy metals namely, aluminum (Al), chromium (Cr), manganese (Mn), cobalt (Co), nickel (Ni), copper (Cu), zinc (Zn), arsenic (As), molybdenum (Mo), cadmium (Cd), tin (Sn), antimony (Sb), mercury (Hg), and lead (Pb) in pregnant women complicated by preterm prelabour rupture of the membranes (pP-ROM) and to compare the results with healthy pregnancies. Methods: Maternal serum levels of Al, Cr, Mn, Co, Ni, Cu, Zn, As, Mo, Cd, Sn, Sb, Hg, and Pb were measured in the study group, which included 55 pregnant women complicated with pP-ROM and 60 healthy pregnancies (control group) with respect to maternal age and gestational weeks. The maternal serum levels of trace elements and heavy metals in both groups were measured using an inductively coupled plasma-mass spectrometry (ICP-MS) and compared.

NCT ID: NCT04074525 Completed - Extreme Prematurity Clinical Trials

Evaluating Decisional Regret Among Mothers

Start date: March 24, 2020
Phase:
Study type: Observational

The anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery. Failure to identify and align decision-making to parents' values during periviabilty counseling may result in greater opportunity for decisional regret. The goal of the proposed research is to assess decisional regret in mothers of extremely premature births and to compare decisional regret in mothers who chose resuscitation at time of delivery to those who chose comfort care. Approximately 1000 mothers of infants born extremely premature at 2 perinatal centers in the US will be surveyed.

NCT ID: NCT04073836 Recruiting - Cerebral Palsy Clinical Trials

GMA and Peri in Moderate-late Preterms

Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

To analyze the relationship between the early diagnosis of cerebral palsy with the risk factors of this pathology in moderate and late premature infants

NCT ID: NCT04068558 Completed - Premature Birth Clinical Trials

sNIPPV Versus NIV-NAVA in Extremely Premature Infants

EASYNNEO
Start date: December 9, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to demonstrate a significant decrease in asynchrony with NIV-NAVA using the Servo n ventilator (Getinge, Sweden), as compared to abdominal triggered (Graseby capsule) synchronized nasal intermittent positive pressure ventilation (sNIPPV) using the Infant Flow CPAP device (Care Fusion, USA). All of the data obtained can be used to develop a large-scale study aimed at reducing the rate of re-intubation in the study population (pilot study). In fact, the re-intubation criteria for extremely premature children are based on clinical criteria (desaturations, apnea, signs of respiratory control) and paraclinical criteria (FiO2, Potential hydrogen (pH), PCO2). The results of this pilot study will help to develop an adapted methodology and to calculate a sample size to compare the 2 modes of NIV to the test on a clinical criterion: the rate of re-intubation after extubation, which is classically high in these patients.

NCT ID: NCT04067973 Not yet recruiting - Premature Clinical Trials

Impact of Prematurity on the Optic Nerve

Start date: September 2, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of this protocol is to study the consequences of prematurity on the optic nerve. Indeed, the work already carried out on the subject suggests that prematurity induces suffering of the optic nerve with a loss of optical fibre, an essential element in the transmission of the visual nerve signal to the brain. The investigators will therefore study two populations: a population of premature infants aged 5 to 10 years, and a control population of term infants. The examinations performed are painless, non-invasive and non-irradiating. To date, there are no known adverse reactions to these tests. These examinations are a photo of the fundus (retinophotography), a pachymetry (measurement of the thickness of the non-contact cornea), an OCT RNFL (optical coherence tomography, scanner of the non-irradiating non-painful optical nerve) and the taking of the IOP (intraocular pressure). They aim to measure the main morphological characteristics of the eye and the optic nerve. This is a prospective observational study. The inclusion and measurements necessary for the study are made on the day of the consultation. The expected results will provide new data on this population of premature infants, allowing for better management if a pathology involving the optic nerve were to occur at any age in these patients.

NCT ID: NCT04067908 Completed - Premature Delivery Clinical Trials

New Biomarkers Associated With the Risk of Premature Delivery.

PROTEOMAP
Start date: June 7, 2011
Phase: N/A
Study type: Interventional

Despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality. This study aims to estimate the prognostic value of new biomarkers (proteomic markers) on the occurrence of preterm birth.