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Prematurity clinical trials

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NCT ID: NCT04000568 Completed - Prematurity Clinical Trials

Breathing Variability and NAVA in Neonates

BRAVe NANO
Start date: May 2, 2019
Phase:
Study type: Observational

The current study is a crossover trial, aiming at evaluating the effect of NAVA -NIV compared to Nasal Intermittent Positive Pressure Ventilation (PC-NIV) at the same level of peak inspiratory pressure, in terms of: breath-by-breath variability of tidal breathing amplitude, variability of the other breathing patterns; lung mechanics; gas exchange; rate of episodes of apnea; bradycardia and desaturations; respiratory asynchrony and comfort, in preterm infants < 37+0 weeks+days post-menstrual age.

NCT ID: NCT03884322 Completed - Prematurity Clinical Trials

Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants

Start date: October 21, 2013
Phase: N/A
Study type: Interventional

Premature very low birth weight (VLBW) infants were placed in two groups matched for birth age. The control group received traditional joint compression exercises designed to decrease bone density loss. Exercises lasted approximately 10 minutes each day 5 days a week. The experimental group were placed in a "prepod", an elastic fabric pod shaped garment or sack on entry into the study and remained in the pod essentially 24 hours a day, with brief breaks for bathing, parental skin to skin experiences,etc. An ultrasound of the left tibia was done on entrance into the study at 31 to 32 weeks gestation and again at completion of the study 4 weeks later. Results showed that experimental infants in pods had slightly less bone density loss than their peers receiving traditional therapy. An incidental finding was that the experimental infants in pods had a significantly shorter length of stay.

NCT ID: NCT03857646 Completed - Prematurity Clinical Trials

The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns

Start date: March 2, 2019
Phase: Phase 4
Study type: Interventional

The goal of this research study is to compare the levels of free fatty acids and free bilirubin between two intravenous lipid emulsion products in premature newborns.

NCT ID: NCT03830580 Completed - Prematurity Clinical Trials

Benefit of Singing in the Care of Premature Children Undergoing Screening for Retinopathy of Prematurity in the Neonatology and Neonatal Resuscitation Unit of the Dijon University Hospital

Voix Chantée
Start date: February 6, 2019
Phase: N/A
Study type: Interventional

As part of the regular procedure for premature births, premature infants undergo several screening examinations, including an examination of the fundus. This examination seeks to establish whether the infant has retinopathy of prematurity. This disease affects the vessels of the retina of the eye, especially in prematurely born children, and can lead to serious complications such as blindness if it is not treated in time. The purpose of this study is to assess the discomfort caused by the screening in order to improve practices. To do this, the investigators would like to evaluate whether soft auditory stimulation, more precisely a person singing, would improve the children's level of comfort during the examination. To do this, the participating children will be divided into 2 groups: - The "Singing" group will receive the usual comfort treatments (placed in a 'nest', pacifier and sugar water) and a trained professional will sing a lullaby or nursery rhyme at the same time - control group will receive the usual comfort care (placed in a 'nest', pacifier and sugar water) The child's head and entire body will be filmed, which will allow an evaluator to assess the child's comfort.

NCT ID: NCT03793309 Completed - Prematurity Clinical Trials

Different Doses of Vitamin D and T Regulatory Cells in Preterm Infants

Start date: January 9, 2017
Phase: Phase 1
Study type: Interventional

This study evaluate the effect of two different doses of vitamin D on T-regulatory cells in preterm infants. Half of the subjects receives 400 IU vitamin D and the other half receives 800 IU vitamin D.

NCT ID: NCT03772080 Completed - Prematurity Clinical Trials

Prematurity Education in High Risk Pregnancies

Start date: November 5, 2018
Phase: N/A
Study type: Interventional

Prematurity is associated with significant morbidity and mortality. Given the high risk of death and disability, it is important for parents to understand the complications of prematurity so they can make decisions for their child. Unfortunately, these discussions often occur in the acute setting of threatened preterm labor when stress and anxiety make comprehension difficult. This study aims to improve parental understanding by providing early education of prematurity in the clinic setting for patients at high risk of preterm delivery.

NCT ID: NCT03767634 Completed - Prematurity Clinical Trials

Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates

Start date: January 1, 2019
Phase:
Study type: Observational

BACKGROUND An essential part of neonatal care is providing nutrition to ensure that babies grow and develop. Providing this can be difficult in premature babies because their intestines are underdeveloped. They often have difficulty digesting milk so feeds are introduced gradually. To help babies grow and develop during this period, additional nutrition may be provided as a fluid into a vein; this is called "parenteral nutrition" (PN). Unfortunately, PN increases the risk of serious complications like bloodstream infection (also known as "sepsis"). For babies who are moderately premature there is little evidence to guide decision making about which babies will benefit from PN. This group of babies have more reserves of fat and are less dependent on PN, but are still at risk of sepsis. As a consequence, some doctors use PN and others do not. AIMS Firstly, to describe which babies are given PN during the first postnatal week in neonatal units in England, Scotland and Wales. Secondly, to determine whether in babies born 7-10 weeks preterm (moderately premature), providing PN in the first week after birth, compared to not to providing PN, improves survival to discharge from the neonatal unit. Finally, to evaluate if the early use of PN in moderately preterm babies affects other important outcomes in the neonatal core outcomes set. IMPORTANCE This work will describe the extent of PN use in England, Scotland and Wales. This is currently unknown. This project will improve understanding of the balance of benefits and harms of PN use in premature babies and will help doctors and parents make informed treatment choices. METHODS The investigators will use the National Neonatal Research Database (NNRD) to study all babies born in England, Scotland and Wales; they will identify which babies were given PN during the first week, and which were not. The investigators will use the NNRD to identify babies born 7-10 weeks prematurely and compare outcomes in babies that were given and not given PN in the first week after birth. The investigators will use statistical techniques to identify two sets of babies in the NNRD who are very similar (in terms of how prematurely they were born, their birth weight, and so on), the only difference being whether they were given PN or not. As the two groups will be similar any difference in their outcomes (such as survival) is likely to be due to whether or not they received PN.

NCT ID: NCT03743207 Completed - Prematurity Clinical Trials

Preterm Infants May Better Tolerate Warmer Feeds

Prematurity
Start date: October 1, 2012
Phase: N/A
Study type: Interventional

Feeding intolerance is frequent among preterm infants in neonatal intensive care units (NICUs). Although there are many studies about enteral nutrition strategies and content in preterm infants, no evidence-based standards exist for the optimal milk temperature for preterm infants. Therefore, in this study the investigators aimed to examine the effects of feeding temperature and the possible morbidities.

NCT ID: NCT03682575 Completed - Clinical trials for Bronchopulmonary Dysplasia

Work of Breathing in Premature Infants at Discharge

Start date: November 10, 2020
Phase:
Study type: Observational

The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not require oxygen for at least 28 days during their time in the NICU.

NCT ID: NCT03533712 Completed - Prematurity Clinical Trials

Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.

MISAME-3
Start date: October 30, 2019
Phase: Phase 4
Study type: Interventional

The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts. The present proposal therefore will 1) perform a formative study to identify the most suitable (acceptability and utilization) BEP supplement for pregnant women in rural Burkina Faso (phase 1) and 2) evaluate the efficacy of this supplement to improve birth weight, fetal and infant growth (phase 2). The nutritional composition of the BEP supplement was established during an expert convening at the BMGF in September 2016. Private sector partners will prepare the supplements in the selected forms with the recommended nutrient composition.