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Premature Birth clinical trials

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NCT ID: NCT03340922 Completed - Catheter Ablation Clinical Trials

MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation

MANIaC-PVC
Start date: June 26, 2018
Phase: Phase 4
Study type: Interventional

Current navigation systems incorporate algorithms for automatic identification of local activation time (LAT). However, data about their utility and accuracy in premature ventricular complex (PVC) ablation procedures are scarce. This prospective, randomized study analyzes the accuracy and effectivity of an algorithmic method based on automatic annotation of the maximal negative slope of the unipolar electrogram within the window demarcated by the bipolar electrogram, compared with conventional, manual annotation during PVC ablation procedures.

NCT ID: NCT03337659 Completed - Premature Birth Clinical Trials

A Cluster Randomized Controlled Trial of FICare at 18 Months

Start date: September 27, 2017
Phase: N/A
Study type: Interventional

In Alberta, one in every twelve babies is born preterm. Compared with their full term counterparts, preterm infants who survive are at higher risk for respiratory problems, jaundice, infections, feeding problems, behavioural problems, and neuro-developmental disabilities, including cognitive delays, and visual and hearing impairments. As a result, parents must leave their preterm babies in the hospital to fully develop enough to care for them at home. When it is time for discharge, parents are often unprepared to look after their baby because they may have limited involvement in the care of their baby in hospital. In addition to the distress and costs to parents of having a baby in hospital, health system costs are also increased the longer a baby is in hospital. The aim of this novel health services study is to assess the longer-term outcomes and costs, to 18 months corrected age, of Family Integrated Care (FICare) for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). A cluster randomized controlled trial (cRCT) of FICare is currently in progress. FICare is a psycho-educational intervention that empowers parents (mothers and fathers) to sequentially build their knowledge, skill, and confidence so the family is well-prepared to care for their preterm infant before discharge. The FICare cRCT evaluates outcomes related to infant global development and maternal psychosocial distress at 2 months. At 2 months, it is difficult to predict longer term outcomes for moderate and late preterm infants. A follow-up study at 18 months will provide evidence of the sustainability of any effects, and longer-term cost savings upon which to inform policy decisions about full-scale implementation of FICare in Level II NICUs.

NCT ID: NCT03334877 Completed - Preterm Labor Clinical Trials

Prediction of Preterm Labor in Asymptomatic High Risk Women

Start date: May 15, 2015
Phase: N/A
Study type: Observational

Two hundred and twenty women with singleton pregnancies and risk factors for spontaneous preterm birth were included in this study. Cervico vaginal fluid sampling was undertaken for qualitative assessment of β -human chorionic gonadotropin (β-hCG) and fetal fibronectin(fFN)at 24 weeks of gestation. For qualitative assay of both b-hCG and fFN, first vaginal specimens were collected by the following method: Specimen collection A sterile Cusco speculum was introduced into the vagina; the anterior lip of the cervix was grasped with sponge forceps and a cotton-tipped swab was placed into the external part of the endocervical canal (not reaching the internal os) and then into the posterior fornix (each for at least 1 min) to obtain an adequate sample of cervico vaginal secretions. Sampling was performed before doing any cervical manipulation (digital or ultrasound examination) and before introducing any vaginal material (lubricants or medications). The Hologic Specimen Collection Kit is the only acceptable specimen collection system which can be used to collect specimens for this assay. The polyester tipped swab provided in the Specimen Collection Kit should be inserted into the vagina and lightly rotated across the posterior fornix for approximately 10 seconds to absorb the cervico vaginal secretions. Once the specimen is obtained, carefully remove the swab from the vagina and place it into the tube of buffer provided with the Specimen Collection Kit. Two Specimen Collection Device per patient were obtained; one for each assay. Label the Specimen Transport Tubes with the patient's name and any other identifying information required. All women were then followed up till delivery. Women were categorized into two arms: women who delivered preterm (before 37 completed weeks of gestation) and women who delivered at term (after 37 completed weeks of gestation).

NCT ID: NCT03334513 Completed - Clinical trials for Retinopathy of Prematurity

Refractive Error and Biometry in Retinopathy of Prematurity

Start date: April 1, 2011
Phase: N/A
Study type: Observational

The investigators compared long-term refractive and biometric outcomes in children with retinopathy of prematurity who received two different anti-vascular endothelial growth factor agents.

NCT ID: NCT03333174 Completed - Infant,Premature Clinical Trials

Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3

Start date: April 9, 2018
Phase: N/A
Study type: Interventional

To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes

NCT ID: NCT03333161 Completed - Infant,Premature Clinical Trials

Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 2

Start date: April 9, 2018
Phase: N/A
Study type: Interventional

To determine if late (at or beyond postnatal day 14) mild permissive hypercapnia is associated with reduction in apnea, bradycardia, and hypoxemic episodes and with improved stability of oxygenation.

NCT ID: NCT03323970 Completed - Premature Birth Clinical Trials

Decision Making in Neonatology : a Qualitative Study

PRODA
Start date: November 2013
Phase: N/A
Study type: Observational

This study aimed to describe and understand the decision making process in neonatology in situations of limiting of withdraw life sustaining treatments, by conducting interviews with physicians from one neonatology unit.

NCT ID: NCT03316547 Completed - Clinical trials for Premature Birth of Newborn

Supporting and Enhancing NICU Sensory Experiences (SENSE)

SENSE
Start date: August 16, 2017
Phase: N/A
Study type: Interventional

Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St. Louis Children's Hospital (SLCH) who were hospitalized in a private NICU room were recruited. The parents of infants in the sensory-based intervention group were educated and supported by trained therapists to give different positive sensory experiences to their infants while hospitalized. The traditional care group received normal, standard care while hospitalized. For both care groups, infant neurobehavior, sensory processing, and parent mental health were measured at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year (corrected). Differences between the two groups were explored.

NCT ID: NCT03313427 Completed - Preterm Infant Clinical Trials

Early Physical Therapy Intervention in Preterm Infants

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

The hypothesis of this study is that early physical therapy intervention, initiated during the NICU stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age). There is a high evidence level of different systematic reviews, which support the effectivity of early intervention with preterm infants. The principal aim of this randomized controlled trial is to evaluate the effectiveness of early physiotherapy intervention to promote motor development in preterm infants at 2 and 8 months corrected age. The secondary purpose is to study the motor development of those preterm infants who received early physical therapy intervention.

NCT ID: NCT03310346 Completed - Clinical trials for Pulmonary Hypertension

Registry of Preterm Newborns With Severe Pulmonary Hypertension

Start date: August 1, 2017
Phase:
Study type: Observational

The purpose of this prospective research registry is to collect data on treatment strategies and outcomes for premature newborns with severe pulmonary hypertension (PH).