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Premature Birth clinical trials

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NCT ID: NCT03673579 Withdrawn - Stress Clinical Trials

Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB

Start date: June 14, 2018
Phase: N/A
Study type: Interventional

This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. Clinicians will be asked to follow their current standard of care practices with the aid of this technology. About half of participants will receive care in NICU rooms with the Dashboard installed while the other half will receive standard care without the Dashboard.

NCT ID: NCT03673566 Withdrawn - Stress Clinical Trials

Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO

Start date: March 20, 2019
Phase: N/A
Study type: Interventional

This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. Clinicians will be asked to follow their current standard of care practices with the aid of this technology. About half of participants will receive care in NICU rooms with the Dashboard installed while the other half will receive standard care without the Dashboard.

NCT ID: NCT03671759 Completed - Clinical trials for Premature Ventricular Contractions

Coffee and Real-time Atrial and Ventricular Ectopy

CRAVE
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) and heart failure (HF) are morbid, costly, and incompletely understood diseases that have reached epidemic proportions worldwide. A dose-dependent relationship exists between premature atrial and ventricular contractions (PACs and PVCs) and development of AF and HF, respectively. Identifying and understanding the mechanisms of additional modifiable risk factors for ectopy has the potential to markedly reduce the healthcare burden of these diseases. In considering how to modify the prevalence of these ectopic beats, the investigators believe common exposures in daily life are prime candidates. Current guidelines suggest that caffeine may be an important trigger for frequent ectopy, although large population-based studies have not demonstrated an association between caffeine consumption and development of clinically significant arrhythmias. No study has employed an actual randomization intervention to assess the effects of caffeine on cardiac ectopy. Utilizing the Eureka platform, the investigators plan to utilize the N-of-1 strategy to rigorously investigate the real-time effect of caffeine intake on ectopy.

NCT ID: NCT03670732 Recruiting - Clinical trials for Respiratory Distress Syndrome

CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure

NICA
Start date: September 30, 2017
Phase: N/A
Study type: Interventional

This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a breathing machine. The latter is known as NIPPV and requires costly equipment to operate. Previous studies did not ensure that the average pressure applied to the lungs was equal and thus did not make for a fair comparison. The investigators believe that when the same average pressure is applied with the two techniques, CPAP is just as effective as NIPPV and may have fewer side effects, such as blowing air into the stomach. Each baby will receive CPAP or NIPPV in a random sequence for a period of 12 hours, followed by 12 hours on the alternate technique.

NCT ID: NCT03668860 Completed - Preterm Birth Clinical Trials

India Dexamethasone and Betamethasone

Start date: September 20, 2018
Phase: Phase 1
Study type: Interventional

An open label, randomized, two-period, crossover, study to compare the pharmacokinetics and pharmacodynamics of single dose Dexamethasone and Betamethasone administered orally and intramuscularly in 48 healthy, adult, female subjects under fasting conditions. This study is being conducted in Bangalore, India.

NCT ID: NCT03668626 Completed - Premature Birth Clinical Trials

Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators

Start date: October 17, 2018
Phase: N/A
Study type: Interventional

This study is to extend our previous research to longitudinally examine the effectiveness of intervention programs (FCIP and UCP) for VLBW preterm children in Taiwan at seven years of age. Gender and maternal education level matched term children will also be included to serve as the reference group for comparison of developmental outcomes. The intervention had been delivered from birth to one year of corrected age in the previous study. Effectiveness examined will include child and parent outcomes. Primary outcome refers to measures of child neurobehavioral and neurophysiological functions. Neurobehavioral assessment includes cognitive, motor and behavioral measurement. Neurophysiological assessment refers to electroencephalogram/event-related potential examination and cognition/motor dual tasks that will be used to investigate the neurological pathways underlying the effective intervention. Secondary outcomes refer to child growth and health, and the quality of parenting measures.

NCT ID: NCT03668327 Recruiting - Preterm Birth Clinical Trials

Preterm Birth Cohort Study in Guangzhou

PBCSG
Start date: February 1, 2012
Phase:
Study type: Observational

The Preterm Birth Cohort Study in Guangzhou (PBCSG) aims to explore the impact of genetic and environmental factors including life styles on preterm birth, to examine the interaction effect between these factors, and to follow up the short-term and long-term outcomes of preterm childrens.

NCT ID: NCT03664154 Completed - Stress Clinical Trials

Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants

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

A majority of mothers experience high stress levels and associated symptoms of anxiety, depressive symptoms, and sleep disruption during the NICU hospitalization and continuing after hospital discharge. Given preterm infant feeding is one of the most stressful things the new mother will face and given the harmful nature of stress on maternal and infant health, it is important an intervention focuses on both of these concerns: infant feeding and maternal stress. Therefore, the purpose of this research study is two-fold. First, the investigators will examine how practical and acceptable it is for mothers of preterm infants to participate in Stress And FEeding (SAFE) intervention and collect biological stress measures from mothers and their preterm infant's saliva (spit). The intervention is designed to reduce stress and improve maternal feeding interaction. The second purpose of this study is to examine changes before and after using the intervention on mother and infant outcomes over 16-weeks.

NCT ID: NCT03663556 Recruiting - Clinical trials for Very Preterm Infants

Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development

FEEDMI
Start date: May 25, 2017
Phase:
Study type: Observational

Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse. Several factors may influence infants' microbiota such as mother's diet, mode of delivery, antibiotic exposure and type of feeding. The main goal of this observational study is to evaluate the impact of different types of feeding (breast milk, donor human milk and preterm formulas) on the intestinal microbiota of preterm infants hospitalized in the neonatal intensive care unit (NICU) of Maternidade Alfredo da Costa (MAC). Furthermore, the influence of mode of delivery and the mother's diet, among others factors, on vertical microbiota transmission will be evaluated. After delivery, mothers will be asked to collect their own fecal samples and will be invited to complete a semi-quantitative food frequency questionnaire. Stool samples will be collected from premature infants every 7 days. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.

NCT ID: NCT03662503 Not yet recruiting - Premature Birth Clinical Trials

Initial Nutritional Strategy and Stature-level Growth During the Neonatal Period of Children Born Moderately Premature

EPIPAGE2
Start date: December 2018
Phase:
Study type: Observational

The growth and nutrition of premature infants during the neonatal period is a concern of neonatology services; it impacts the child's health in the short and long term. The weight deficit, but especially the weak growth of the cranial perimeter during the Neonatal period is associated with an increased risk of long-term neuro-cognitive impairment. The optimal nutritional strategy, during the neonatal period, of children born moderately premature is not known. The optimization of nutrition in premature children is therefore a topical issue in neonatology. Our project aims to evaluate the impact of an aggressive early nutritional strategy characterized by optimized caloric and protein intakes on the stature-level growth of 2000 children born moderately premature GA from 30 WA (week of amenorrhea) to 32 WA + 6 days and included in the national cohort of follow-up of children of small gestational ages. Nutritional intake during the first week of life will be analyzed in tertile. Children will be grouped according to their calorie and protein during the first week of life. The tertile 1 will represent the group of children with the lowest nutritional intake (called the "nutrition not aggressive "), the tertile 3 will define the group of children presenting the contributions highest nutritional levels (called the "aggressive nutrition" group). The primary endpoint will be the z-score change in weight, height and head circumference between birth and age (36 adjusted age WA) between the "nonaggressive nutrition" group and the group. "Aggressive nutrition". The benefits are for public health to harmonize neonatal care practices within a region and to better understand the impact of nutritional strategies on long-term neuro-cognitive development.