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Infant, Premature clinical trials

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NCT ID: NCT02999165 Terminated - Breast Feeding Clinical Trials

Breastfeeding Infants Receiving Respiratory Support Trial

BIRRST
Start date: November 2016
Phase:
Study type: Observational

The purpose of this study is to assess whether two methods of breathing support in babies called 'Humidified High-Flow Nasal Cannula' oxygen (HHFNC) and 'nasal Continuous Positive Airways Pressure' (nCPAP) are compatible with breastfeeding. Many babies who are premature or unwell after birth require help with their breathing. This is often achieved by blowing a continuous flow of air through the nose and down into the lungs in order to reduce the amount of effort the baby needs to inflate the lungs during breathing. Currently some centres allow babies to breastfeed whilst undergoing breathing support whilst other centres do not in case there is an increased risk of choking or other harmful events. In the latter case, babies are fed using a nasogastric tube (NGT) that runs from the baby's nostrils into their stomach. At this centre, babies are allowed to breastfeed whilst simultaneously on either HHFNC or nCPAP. This is because the concerns over the choking risk are not evidence based. This study aims to conclusively prove that thisfeeding protocol is safe and then to expand into other areas of research to find out the following: - Whether breastfeeding during nCPAP or HHFNC leads to babies establishing full breastfeeding sooner (and subsequently reduce the length of their stay in hospital) - What the effects of breastfeeding of nCPAP or HHFNC are on a baby's parents (e.g. whether it enhances bonding) - If nCPAP and HHFNC have different effects on breastfeeding As part of this study the investigators will observe stable babies on nCPAP or HHFNC during breastfeeding episodes. The investigators will monitor the babies for signs of distress or instability and whether they are more stable when breastfeeding is not occurring. This will be compared to an episode where the same baby is fed by NGT to see which technique is better.

NCT ID: NCT02863978 Active, not recruiting - Infant, Premature Clinical Trials

Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database

Digi-NewB
Start date: November 8, 2016
Phase: N/A
Study type: Interventional

Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic. The Rennes University Hospital was granted a specific funding from the European Union in the framework of the Horizon 2020 programme (Call PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to develop the Digi-NewB project. This project aims to develop innovative non-invasive monitoring tools to support decision making in health. Such tools include a new generation of real time monitoring in neonatology using composite indices made of cardio-respiratory variables, movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all physiological data relevant for the creation of the composite indices.

NCT ID: NCT02848755 Completed - Infant, Premature Clinical Trials

Brain Volumes of Very Low Birth Weight Infants Measured by Cranial Ultrasonography

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

Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high risk preterm infants on neonatal intensive care units (NICU). It is a non-invasive, inexpensive bedside tool and examinations can be repeated as often as necessary without major disturbance of vulnerable infants. The anterior and posterior fontanelles from excellent acoustic windows to examine the deep midline and periventricular regions of the brain.Some data demonstrated that cerebral palsy can be accurately predicted with US. However, cranial US is not very suitable for investigating cortical regions or structures in the posterior fossa. There is limited data for very preterm infants.The investigators aimed to measure ventricular index, cranial height, biparietal diameter and calculate brain volume in a huge number of infants.

NCT ID: NCT02818595 Completed - Infant, Premature Clinical Trials

Development of Maternal Voice Recognition in Preterm Neonates

PREMAVOIX
Start date: March 2013
Phase: N/A
Study type: Interventional

Many cognitive functions in humans are based on asymmetrical brain networks. For example, in most adults, the language is essentially processed by the left hemisphere, while other auditory functions, such as voice recognition, tend to be processed by the right hemisphere. Many studies, especially those conducted by Ghislaine Dehaene's team, have demonstrated the presence of anatomical and functional asymmetries by the first months of life. What are the causes of these asymmetries? How do they develop? Are they necessary for functioning or effective learning? This study, conducted in collaboration with the Compiègne applied mathematics team (Abdelatif El Badia) and the INSERM team (Ghislaine Dehaene), is designed to determine the stage of development at which hemispheric dominance for voice recognition is first observed and to identify the brain structure involved in preterm neonates whose sound environment is usually very different from that of the foetus. The impact of this environment on the infant's brain development and early learning will be evaluated.

NCT ID: NCT02811029 Recruiting - Infant, Premature Clinical Trials

Language and Motricity in Preterm School Age Children

LAMOPRESCO2
Start date: July 2016
Phase: N/A
Study type: Interventional

A total of 40% of neurodevelopmental difficulties have been reported in very premature infants less than 32 weeks of age. The Epipage1 study reported a decreasing prevalence of cerebral palsy (9-6%) but a high prevalence of specific cognitive neurological difficulties and an increase in school failure. Neurocognitive difficulties are numerous: visuospatial dyspraxia, language disorders, executive function disorders as well as attention and behaviour disorders. Developmental language disorders have been rarely reported in the literature. This originally prompted our request i.e. PHRC 2010 National Multicenter: LAMOPRESCO. For the past 3 years this protocol has studied the language development of children who were born very prematurely, aged 3 and a half years free of cerebral palsy, in particular the impact of a short rehabilitation period, precise, at an early stage, and protocolized on a fundamental sensorimotor language. The principal assessment criterion was the measurement of phonology, the cornerstone of oral and written language in humans. The aim of the present project is an analysis of the effect that this specific language stimulation has on the learning of written language. The hypothesis is that a specific work modifying various aspects of a child's language, during the age of 3 to 4, alters the development of phonological skills in a sustainable way. The acquisition of reading skills is basically dependent on the quality of its phonological components. The randomized study of children up to 8 years of age in a cohort of 150 children (LAMOPRESCO) will permit to confirm or refute this hypothesis. These increasing difficulties have been reported as regards the language understanding of 3 to 15 year old children. It is as if the initial difficulties and weaknesses, which moreover constituted oral language, prevented the use or development of neural networks, which became more complex and required both an oral and written language. Are these elements which constitute phonology, at an early stage, modifiable before the close of the clinically measurable developmental window?

NCT ID: NCT02738411 Active, not recruiting - Infant, Premature Clinical Trials

Influence of Intestinal Microbiota Implantation in Preterm Infants on Microbiota and Immune Orientation at 3 Years

PrimiBiota
Start date: May 12, 2017
Phase:
Study type: Observational

The main objective of this research is to study the links between changes in the intestinal microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and the presence / absence of a TH1 immune status at 36 months of age.

NCT ID: NCT02691156 Completed - Infant, Premature Clinical Trials

Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants

Start date: February 1, 2016
Phase:
Study type: Observational

Most preterm newborns are managed by phototherapy to reverse hyperbilirubinemia with the intent to prevent bilirubin neurotoxicity. A threshold-based relationship between a specific total bilirubin level and need for intervention has been elusive. This is most likely due to other biomarkers such as hemolysis, developmental maturation, concurrent illnesses, or even interventions, may impede bilirubin/albumin binding. The over-prescription of phototherapy has impacted clinical and family-centered care, and in the extreme preterm infants, it may have augmented their risk of mortality. Thus, the opportunity to individualize phototherapy in in order to reduce its use is unique. The investigators have assembled a transdisciplinary team to examine critical unanswered questions including the role of bilirubin binding capacity (BBC) of an individual during the first week of life in the context of clinical modifiers and antecedents for a domain of bilirubin-induced neurologic disorders, that includes neuro-anatomical, hearing, visual and developmental processing impairments. In this study, the investigator will evaluate two new innovative nanotechniques to quantify bilirubin load for the first time in the context of a clinical decision algorithm to identify those most at risk for any bilirubin-related neurotoxicity. The investigators anticipate that knowledge gained from this study will lead to ethically testable hypotheses to individualize the prescription of phototherapy.

NCT ID: NCT02673385 Completed - Infant, Premature Clinical Trials

Study of the Impact of Administering t the Scale of Brazelton on the Mother's Confidence in Her Newborn Born Premature at the Approach of Returning Home

BRAZMAMAN
Start date: March 15, 2016
Phase:
Study type: Observational

In France, the last national perinatal survey show that 6.6% of live births are premature. For these infants, transfer in Neonatology sector may result in mother-child separation can last several weeks or months. This hospital can complicate the implementation of the attachment process that allows parents to recognize their children as their own, to gain confidence in their abilities to deal with them and establish a relationship with him. A study of mothers of premature shows the interest of the Brazelton scale to help them identify the skills their child and adjust their own behavior.

NCT ID: NCT02650167 Completed - Infant, Premature Clinical Trials

Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea

COLOSTRUM
Start date: April 27, 2016
Phase: N/A
Study type: Interventional

Colostrum is the first milk secreted by the mother when the tight junctions of mammary epithelium open, allowing the cellular transport of a multitude of components and immunological protective derivatives of the maternal circulation to the milk, and especially immunoglobulins A type. Colostrum is not given to preterm neonates. The assumption behind this work is that the oro pharyngeal administration of colostrum early in preterm infants could help deliver an oral immunotherapy even before the installation of enteral nutrition, through interactions with lymphoid tissues of the oropharynx and the gastrointestinal tract. This practice would improve the digestive tolerance and the establishment of enteral feeding, the decrease in mucosal inflammatory phenomena, but also to provide any protection against subsequent infections. Finally, there could be an improvement in the secondary immune tolerance with a decrease in the occurrence of allergic phenomena.

NCT ID: NCT02611284 Completed - Infant, Premature Clinical Trials

Less Invasive Beractant Administration in Preterm Infants

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

The aim of this study is to assess the efficacy and feasibility of a new less invasive surfactant administration (LISA) technique with a specific designed cannula for surfactant administration using Beractant replacement in preterm infants <32 weeks of gestation and compare short and long term outcomes with the intubation, administration of surfactant and extubation method (INSURE). This was a single-center, prospective, open-label, non-randomized, controlled study with an experimental cohort of 30 patients treated with LISA and a retrospective control group comprising the 30 most recently treated patients with INSURE. Beractant (4 ml/Kg) was administered as exogenous surfactant in both groups if patients on nasal continuous positive airway pressure (nCPAP) during the first three days of life were needed of more than 30% of fraction of inspired oxygen inspired oxygen fraction (FiO2).