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Infant, Premature clinical trials

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NCT ID: NCT05016167 Completed - Infant, Premature Clinical Trials

The Effect of Replacement Frequency of Electrodes on Skin in Infant

Start date: August 31, 2018
Phase: N/A
Study type: Interventional

In the Pediatric Intensive Care Unit (PICU), each child and infant is monitored to determine the status of the underlying disease by constantly monitoring the main variables, to help diagnosis and to guide treatment. During the monitoring application, electrodes of appropriate size for the patient's age and body surface are attached to the appropriate areas of the patient where skin integrity is intact, clean, and dry. It is recommended that these electrodes be replaced within 24 hours at most, but there is no evidence of the effect of electrode replacement frequency on skin moisture and integrity. Based on this reason, this study was conducted experimentally in a randomized controlled manner to determine the effect of frequency of monitoring electrode replacement on skin moisture and condition of infants hospitalized in the PICU.

NCT ID: NCT04624347 Completed - Neurologic Disorder Clinical Trials

NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants

Start date: November 17, 2020
Phase: N/A
Study type: Interventional

Very premature birth and the necessary hospitalization expose to a risk of morbidity and mortality which impacts the neurodevelopmental prognosis. Sleep and behavior monitoring have not been developed in the neonatal units. This has to be improved since it is known from clinical and animal studies that the quality, organization and quantity of sleep in very preterm infants impact neurological development and brain plasticity. The collection system provide neonatal care nurse with access to motion curves (evaluated by signal processing of live video) and real-time infrared video (also available in low-light conditions). This new non-invasive technology allows an evaluation of the activity cycles of the newborn by the caregivers which until now was only accessible occasionally by short recordings of actigraphy or polysomnography. The investigators wish to demonstrate that this can contribute to an organization of care that respects the sleep patterns of the newborn, which they know to condition the neurodevelopmental prognosis.

NCT ID: NCT04402645 Active, not recruiting - Clinical trials for Pulmonary Hypertension

Novel Echocardiographic Methods for Early Identification of Neonates at Risk for Chronic Pulmonary Hypertension

Start date: August 31, 2017
Phase:
Study type: Observational

Chronic pulmonary hypertension (cPHT) is a serious cardiopulmonary disorder that causes low oxygen levels in the blood, difficulty in breathing and ultimately heart failure. Newborn babies born extremely premature frequently suffer from cPHT while receiving treatment in neonatal intensive care units and are more likely to die than those without cPHT. Echocardiography is the investigation of choice for the assessment of heart function in premature infants however however there is a significant lack of standardization, sensitivity, and reliability for echocardiography parameters and a lack of consensus regarding optimal detection timing. In adults and older children it is known that early diagnosis and treatment, particularly before right side of the heart fails, is an important determinant of treatment success and survival. Diagnosis late in postnatal course for preterm infants remains a major barrier to timely and effective treatment. The primary objective of this study is to develop new, sensitive, quantitative echocardiographic diagnostic criteria which will allow for the identification of extreme preterm neonates suffering from significantly high pressure in their pulmonary blood vessels, early in postnatal course, when the disease is likely to be most amenable to preventative/curative treatment. This is an international initiative that will leverage expertise about echocardiography techniques and cardiopulmonary physiology of preterm infants.The results of this study will have an immediate impact on the day-to-day care of these highly vulnerable infants. The results will lead to increased awareness among clinicians, inform future surveillance protocols and diagnostic timing, and provide ideal preparation for future therapeutic trials.

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: NCT04050384 Completed - Pain Management Clinical Trials

Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates

Start date: November 13, 2018
Phase: N/A
Study type: Interventional

The assessment and treatment of pain in neonates remains a challenge. In an effort to improve the quality of care while limiting opioid-related adverse effects, this study aims to determine the efficacy of a non-pharmacological intervention on the mitigation of nociception-specific responses to a skin breaking procedure in term and preterm neonates. Such responses will be measured using behavioral measures as well as with electroencephalography-based methods.

NCT ID: NCT03840980 Terminated - Microbiota Clinical Trials

The Alberta BLOOM Preterm Neonate Study

BLOOM-PTN
Start date: January 14, 2019
Phase:
Study type: Observational

This is a prospective, observational clinical cohort study involving 100 mothers and their very preterm infants born at less than 32 weeks gestation. The purpose of this study is to gain a thorough understanding of the microbiome (the collection of microbes in a biological site) establishment in very preterm infants. The study will also examine the perinatal factors associated with the pattern of microbiome development, the metabolome and immune development of this population in the first months of life. All participants will be recruited from the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre (FMC) in Calgary, Alberta, Canada. Premature birth (birth before 37 weeks of pregnancy) occurs in about one in ten pregnancies each year. Babies that are born after less than 32 weeks of pregnancy are considered to be very premature babies. When babies are born very prematurely their gut is not as developed. One important factor in gut health is the large community of microbes (tiny living things such as bacteria) that live on the human body called the microbiome. Recent studies have shown that premature babies are more likely to have changes in their gut microbiome that are associated with health issues. However, sciences has not yet discovered what specific microbiome features are involved in development of premature babies. Therefore, this study examines the impact of very premature birth on the premature baby's microbiome. The kind of microbes that make up the microbiome in the gut in the first months of life have a major impact on the microbiome that will form during childhood. There are many environmental factors during pregnancy, birth and in first months of life that can impact the microbiome development. These factors include diet, exposure to antibiotics, surgical procedures, and birth mode. This study will investigate how these factors influence the types of early microbes present in preterm infants. The hypothesis of the study is that specific microbial patterns, trajectories and/or metabolites will be significantly associated with single or a combination of perinatal maternal and/or infant factors. The primary objective of the study is to learn more about the development of the microbiome in very premature babies in the first months of their life. To do this, participating baby's stool and urine samples will be studied. A secondary objective of the study is to find out how environmental factors impact the development of the microbiome and the health of preterm infants. In order to do this, maternal microbiome samples will be studied and information regarding maternal health, nutrition and environment during pregnancy will be collected. As well, information about the birth and health of participating preterm neonates will be collected.

NCT ID: NCT03742635 Completed - Infant, Premature Clinical Trials

Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine

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

The investigators will implement a study to evaluate the hypothesis that applying General Movements Assessments (GMA) in a telemedicine setting with real-time scoring is feasible and comparable to scoring video recordings.

NCT ID: NCT03696758 Completed - Infant,Premature Clinical Trials

Improving Right Ventricular Function in Young Adults Born Preterm

Start date: October 30, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this research is to evaluate the short-term effects of sildenafil and metoprolol on heart function in young adults born premature.

NCT ID: NCT03693287 Recruiting - Growth Clinical Trials

Personalized vs Standardized PN for Preterm Infants >1250g

Start date: July 4, 2021
Phase: Phase 4
Study type: Interventional

Preterm infants (gestational age between 189 and 258 days) with a birth weight (BW) greater than 1250 grams will be randomized to personalized-parenteral nutrition (P-PN) or standardized-parenteral nutrition (S-PN). The aim of the study is to evaluate the effect of S-PN versus P-PN on growth of preterm infants with BW>1250 grams.

NCT ID: NCT03586856 Completed - Infant,Premature Clinical Trials

Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment

ToNIL
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

The study is a two-armed randomized cross-over comparison of leakage with nasal prongs and nasal mask interface in newborn infants treated with CPAP, born after 28 weeks of gestational age. For infants with an interface leakage, the trial also includes an observational part evaluating simple measures to reduce leakage. The study will be carried out in the Karolinska University Hospital Stockholm and in the Östersund Hospital.