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Preterm Infant clinical trials

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NCT ID: NCT04062513 Not yet recruiting - Pain, Acute Clinical Trials

Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

Start date: September 2019
Phase: N/A
Study type: Interventional

Repeated and untreated pain can lead to long-term consequences in preterm infants, such as pain hypersensitivity and impaired motor and intellectual development. Studies on the pharmacological and non-pharmacological interventions for pain management in preterm infants are limited. Thus, we investigated an intervention based on olfactive stimulation with mothers' milk. The aims of this study are: a) Evaluate the effectiveness of an olfactive stimulation intervention with mothers' milk odor on preterm procedural pain; b) Evaluate the effectiveness of adding a period of familiarization previous to the olfactive stimulation intervention with mothers' milk odor on preterm procedural pain. Preterm infants will be recruited and randomly assigned to three groups 1) mothers' milk odor during the nine hours before and during heel-prick, 2) mothers' milk odor during heel-prick, 3) standard care. Pain will be measured using a scale of pain adapted for preterm infants. This procedure with mothers'milk odor is inexpensive and easily performed.This study will significantly contribute to the advancement of knowledge on preterm infants pain management.

NCT ID: NCT04009655 Completed - Preterm Infant Clinical Trials

The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants

Start date: August 15, 2019
Phase: N/A
Study type: Interventional

Music has been consistently shown magic power in brain plasticity. Several study proved music can influence electronic activity of preterm infants' brain, while none study covered region oxygen metabolic. The investigators aim to discover the effects of music therapy on near-infrared spectroscopy and electroencephalogram in premature infants.

NCT ID: NCT04008498 Completed - Preterm Infant Clinical Trials

AEEG in Pre-term Infants

AEEG
Start date: May 30, 2018
Phase: N/A
Study type: Interventional

Amplitude integrated encephalography (aEEG) is a monitor that measures brain activity by attaching leads to a baby's head, and is used routinely in term babies who have brain injury because of a difficult birth. There is little information on how useful aEEG is in premature babies, and most studies only look at small numbers of babies. However, these studies suggest that the aEEG is different in premature babies with brain injury, infections / meningitis, and in those receiving certain drugs. It is also affected by changes in blood pressure and blood acid levels. It is theoretically possible that, if the investigators can detect changes using aEEG early on, the investigators will be able adjust treatment to make a baby better.

NCT ID: NCT03942757 Completed - Preterm Infant Clinical Trials

BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

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

Phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. Guidelines focus mainly on bilirubin serum levels to start the phototherapy. Only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. Especially there are no strong recommendations about phototherapy duration, irradiance measurements, incubator temperature and humidity settings. Various factors can influence irradiance and thus the preterm infant bilirubin serum decrease. This study aims at evaluating the impact of an educational program on the use and efficacy of phototherapy in a neonatal intensive care unit.

NCT ID: NCT03939546 Completed - Preterm Infant Clinical Trials

The FOUNDATION Study

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

The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit for the infant consuming breast milk when B. infantis is colonized in the gut.

NCT ID: NCT03931902 Completed - Anesthesia Clinical Trials

The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates

Start date: September 12, 2019
Phase: N/A
Study type: Interventional

Objectives: To compare the perioperative respiratory adverse events between using laryngeal mask airway and endotracheal tube in preterm neonates receiving general anesthesia for hernia surgery.

NCT ID: NCT03928457 Active, not recruiting - Preterm Infant Clinical Trials

Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate

NeuroPrem-RF
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The massive use of highly technological devices in Neonatal Intensive Care Units may expose preterm neonates to electromagnetic fields, especially radiofrequencies, at low doses but continuously and chronically. Strikingly, the effect of long-term exposure to radiofrequencies on the neurophysiological development of preterm neonates has never been studied so far. The only studies on the impact of chronic exposure to radiofrequencies have been conducted in animals or adult humans, whereas preterm infants may be particularly vulnerable due to increased penetration of radiofrequency waves into the brain during a crucial period of neurodevelopment. The present project will aim at 1) quantifying individual levels of chronic exposure (during 6 weeks) to which preterm neonates are subjected during their stay in the Neonatal Intensive Care Unit, 2) following the evolution of the thermal environment and of the clinical parameters of the neonates after birth, 3) identifying potential alterations of neurophysiological activity (sleep, cerebral hemodynamics, autonomic nervous activity) which will be correlated to actual levels of chronic RF-EMF (radiofrequency electromagnetic fields) exposure.

NCT ID: NCT03919188 Recruiting - Preterm Infant Clinical Trials

Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity

ThermoKPreterm
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment. The investigator research hypothesis is that a new calculation of the air temperature in the incubator would promote the newborn infant weight growth from the period between birth and day 10 of life compared to cutaneous mode. The secondary hypotheses assumes a decrease in the side effects usually observed in both morbidity and mortality. A software is used to calculate the body heat loss (BHL) of each individual preterm infant, and to propose a specific air temperature setting inside the incubator to reduce BHL to zero. This software has been validated in a previous pilot study (Degorre et al. 2015). This study aims to compare the energy costs of providing incubated preterm infants born between 25 and 32 weeks of gestation with homeothermia using either specific individualized air temperature control (ATC) or skin servocontrol (SSC).

NCT ID: NCT03895242 Completed - Preterm Birth Clinical Trials

Prone and Supine Positions in Preterm Infants Receiving Mechanical Ventilation

Start date: February 2015
Phase: N/A
Study type: Interventional

Positioning, which is one of the individualized developmental care methods, is known as the important care support process which is applied with the purpose of ensuring the least damage from the environmental. Positioning in preterm infants is the basis of neonatal nursing care. Positioning in preterm infants receiving mechanical ventilation support is important in terms of physiological and neurodevelopment. In infants undergoing respiratory support in NICU, it is important to determine the appropriate position, the frequency and duration of position change in order to reduce the oxygen need. In this respect, the aim of this study, designed as a randomized controlled trial, was to determine the effect of supine and prone positions on physiological variables (oxygen saturation and heart rate) of preterm infants receiving mechanical ventilation.

NCT ID: NCT03853161 Recruiting - Preterm Infant Clinical Trials

High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants

VAPORAM
Start date: January 21, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to compare the effectiveness of Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in preventing intubation when used as primary respiratory support for Respiratory Distress Syndrome (RDS) or post extubation in preterm infants