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Premature Birth clinical trials

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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: 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: 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.

NCT ID: NCT04067206 Completed - Premature Birth Clinical Trials

The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants

Start date: September 10, 2017
Phase: N/A
Study type: Interventional

This study investigated the effects of three interventions —recorded mother's voice, white noise, and MiniMuffs, muffs used to attenuate environmental sounds— applied during a heel lance on pain and comfort in premature infants. This randomized controlled research was conducted in a state hospital tertiary-level neonatal intensive care unit. Sixty-four premature neonates with a gestational age of 31-36 who were stable, didn't receive mechanic ventilation and has been started feeding participated. The infants were randomly assigned to four groups: i) white noise , ii) recorded mother's voice, iii) MiniMuffs (earmuff), and iv) control. Five minutes before the procedure the white noise and mother's voice played and MiniMuffs placed on babies' ears. The heel lance procedure was recorded on a camera. The camera recordings were evaluated for premature infants' pain and comfort according to the Neonatal Infant Pain Scale (NIPS) and the Comfort behavior (COMFORTneo) scale.

NCT ID: NCT04062851 Completed - Preterm Infant Clinical Trials

Routine Versus no Assessment of Gastric Residual Volumes in Preterm Infants

Start date: May 3, 2019
Phase: N/A
Study type: Interventional

The practice of checking gastric residuals is not evidence based. The amount of gastric residual volume (GRV) does not correlate with either feeding intolerance or development of NEC. We hypothesize that not monitoring GRV in infants with birth weights < 1,250 g, and who are being fed intermittently by gastric tube, will result in earlier attainment of full feeding. This is an unblinded randomized controlled trial where GRV will not be checked routinely in the intervention group.

NCT ID: NCT04062357 Completed - Lidocaine Spray Clinical Trials

Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients.

PE
Start date: April 20, 2018
Phase: Phase 2
Study type: Interventional

This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.