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Sudden Infant Death clinical trials

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NCT ID: NCT03278977 Recruiting - Clinical trials for Apparent Life-Threatening Event in Infants Under One Year of Age

Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors

iALTE
Start date: September 15, 2018
Phase: N/A
Study type: Interventional

Apparent Life-Threatening Events (ALTE) in infants often lead to severe neurological complications or to sudden death. In such situations, cardio-pediatricians and intensive care physicians have no specific diagnosis or treatment. In a recent translational research (INSERM-DHOS), our team has reported a myocardiac abnormality in a rabbit model of vagal hyperreactivity which is also present in the human hearts of infants deceased from sudden death, i.e. increased M2 muscarinic receptors (M2R) density associated with compensative increased enzymatic activity and overexpression of acetylcholine esterase (AchE). In a recent PHRC-I study (article in preparation), these abnormalities have also been observed in the blood of patients, infants as well as adults, exhibiting severe vagal syncopes. We observed, even more importantly, similar abnormalities in infants under 1 year of age with very severe idiopathic ALTE (iALTE) compared with normal subjects and with patients who presented ALTE with identified etiologies (JAMA Pediatric, 2016 May). The aim of this present study is to validate the overexpression of M2R as a marker of risk of iALTE in infant under 1 year.

NCT ID: NCT03186469 Active, not recruiting - Sudden Infant Death Clinical Trials

Generations in Families Talking Safe Sleep

GIFTSS
Start date: October 7, 2014
Phase: N/A
Study type: Interventional

Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant mortality, in part because they may not be the sole decision-maker for an infant's sleep environment and position and they make seek advice from older female support people. Investigators will conduct a randomized controlled trial of a educational intervention to mitigate the risks of unsafe infant sleep practices across generations. Given the complexity and variability of teen-SCG relationships, investigators will include an examination of inter- and intra-personal factors that are key control variables or may mediate the uptake of safe sleep recommendations. Investigators believe that the intervention will empower support people to positively influence a teen mother's adoption of safe sleep recommendations.

NCT ID: NCT03070639 Completed - Clinical trials for Sudden Infant Death Syndrome

Enhancing Safe Sleep Practices of Urban Low-Income Mothers

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

The specific aims of the study are to: 1) evaluate the impact of the safe sleep intervention on parents' knowledge, beliefs, intentions, skills and practices related to creating and maintaining a safe sleep environment for their infants during the first four months of life; 2) describe the characteristics of physician anticipatory guidance about safe sleep and identify physician, patient and parent characteristics associated with coverage of the topic at the well-child visits; and 3) evaluate the dissemination of the B'more for Healthy Babies (BHB)'s safe sleep campaign messages and services among our study participants.

NCT ID: NCT02376673 Completed - Clinical trials for Sudden Infant Death Syndrome (SIDS)

Comparing Children's Book to Brochures for Safe Sleep Education in a Home Visiting Program

Start date: June 2014
Phase: N/A
Study type: Interventional

This randomized controlled trial compares a specially-designed children's book to standard brochures for safe sleep education and reduction of Sudden Infant Death Syndrome (SIDS) risk in a high-risk population of young, first-time mothers enrolled in a home visitation program. Roughly half of the mothers will receive safe sleep education via the book, the other half via brochures, during prescribed home visits. Our study will assess differences in safe sleep knowledge, adherence to recommendations, satisfaction with materials used, and attitudes towards reading with their baby. Our hypothesis is that these will be higher in the group receiving the book, due to simpler language, appealing illustrations, emotional connection, and repeated exposures via shared reading.

NCT ID: NCT02189265 Completed - Premature Birth Clinical Trials

Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands

Start date: January 2000
Phase: N/A
Study type: Observational

The purpose of this study is to investigate whether there has been a change in perinatal outcomes following the phased smoking ban introduction (January 2004 for workplaces; July 2008 for bars and restaurants) workplaces in the Netherlands.

NCT ID: NCT02039583 Completed - Stillbirth Clinical Trials

Impact of Smoke-free Legislation on Early-life Mortality and Low Birth Weight in England

Start date: January 1995
Phase: N/A
Study type: Observational

The purpose of this study is to investigate whether there has been a change in low birth weight and perinatal and infant mortality following the July 2007 introduction of a ban on smoking in public places and workplaces in England.

NCT ID: NCT01888380 Completed - Stillbirth Clinical Trials

The Paediatric Virtual Autopsy Trial

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

In light of declining autopsy rates around the world, post-mortem MR imaging is a promising alternative to conventional autopsy in the investigation of infant death. A major drawback of this non-invasive autopsy approach is the fact that histopathological and microbiological examination of the tissue is not possible. The objective of this prospective study is to compare the performance of minimally invasive, virtual autopsy, including CT-guided biopsy, with conventional autopsy procedures in a paediatric population. Foetuses, newborns, infants and children that are referred for autopsy at three different institutions associated with the University of Zurich will be eligible for recruitment. All bodies will be examined with a commercial CT and a 3 Tesla MRI scanner, and investigators will be blinded to the results of conventional autopsy. After cross-sectional imaging, CT-guided tissue sampling will be performed by a multifunctional robotic system (Virtobot) allowing for automated post-mortem biopsies. Virtual autopsy results will be classified with regards to the likely final diagnosis and major pathological findings and compared to the results of conventional autopsy, which remains the diagnostic gold standard. This interdisciplinary study will determine whether virtual autopsy will narrow the gap in information between non-invasive and traditional autopsy procedures.

NCT ID: NCT01417962 Completed - Sudden Infant Death Clinical Trials

Magnetic Resonance Imaging Autopsy Study

MARIAS
Start date: March 2007
Phase: N/A
Study type: Observational

The aim of this project is to establish whether magnetic resonance (MR) imaging can provide a minimally invasive approach for post-mortem assessment of the fetus, infant and child, with similar detection rates for anomalies and determination of the cause of death. This will be achieved by acquiring a database of whole-body, post-mortem MR images in approximately 400 fetuses, infants and children, over a 3 years period. Images will be acquired on a dedicated 1.5T research MR scanner. MR images will be reported by an expert group of paediatric radiologists, and compared, in a blinded fashion, with reports from conventional autopsy performed by expert perinatal and paediatric pathologists. Importantly, the post-mortem information will be assessed with reference to the needs of the parents, referring clinicians and HM Coroners. The detection of central nervous system abnormalities will be assessed separately. The study will be performed across two sites: A dedicated children's hospital (Great Ormond Street Hospital) and a teaching hospital, with large obstetric, fetal and neonatal departments (University College London Hospital), which are linked academically by University College London. Co-ordination of the project will be managed by a steering committee, which will ensure accurate collation and comparison of the data.

NCT ID: NCT01361893 Completed - Clinical trials for Sudden Infant Death Syndrome

Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS)

SIDS
Start date: December 2004
Phase: N/A
Study type: Interventional

The overall purpose of this investigation is to better understand factors contributing to the high incidence of prone sleep positioning in African-American infants. In addition, the investigators are interested in investigating other races and ethinicities to understand their beliefs and perceptions and determine differences socioeconomically and socioculturally within and between groups. The investigators will address the following specific aims: (-) To compare knowledge, attitudes, and practices regarding infant sleep position in parents of higher and lower SES. (-) To identify risk factors for non-use of recommended supine sleep position in families with higher and lower SES (-) to develop a phenomenologic understanding of the decisions made by parents of higher SES and lower SES who do nt use recommended supine sleep position, using qualitative techniques.

NCT ID: NCT01265277 Completed - Clinical trials for Sudden Infant Death Syndrome

Changes in Sleep Patterns and Stress in Infants Entering Child Care

Start date: July 2009
Phase:
Study type: Observational

When babies start day care, they experience many changes, some of which may affect their risk for sudden infant death syndrome (SIDS). The investigators want to find out if stress or change in the baby's sleep patterns can be a reason for this increased risk for SIDS.