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Prematurity; Extreme clinical trials

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NCT ID: NCT05827250 Recruiting - Premature Birth Clinical Trials

Vibroacoustic Study of Lung Development in Newborn Infants

Start date: February 13, 2023
Phase:
Study type: Observational

Investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes. Investigators further hypothesize that audible sounds combined with novel inaudible vibrations above and below human perception interpreted with transparent and auditable AI algorithms can detect and identify early gas and fluid movement anomalies not uncovered by conventional tools in an non-invasive, easy, fast, and low cost examination.

NCT ID: NCT05824377 Recruiting - Feeding Patterns Clinical Trials

To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

To evaluate the duration to reach full feeds by comparing continuous gavage feeds versus bolus feeds in preterm infants who are on non-invasive respiratory support (RAM cannula - short binasal prongs).

NCT ID: NCT05684419 Completed - Clinical trials for Prematurity; Extreme

Preterm Infants Born to Homeless Mothers.

PREMA-NEUF
Start date: July 29, 2022
Phase:
Study type: Observational

In recent years, the number of homeless patients who are accommodated by the SAMU social has increased. These patients are in a situation of financial, but also often social and psychological precariousness. The literature already shows us that precariousness and homelessness are a risk factor for prematurity, but also for the patients themselves, a risk of more frequent recourse to emergency services and of late consultation for advanced pathologies. The objective of this study is to evaluate the fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers.

NCT ID: NCT05615311 Recruiting - Clinical trials for Prematurity; Extreme

Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm

Start date: March 16, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin D dose recommended during the first 14 days after birth.

NCT ID: NCT05280340 Recruiting - Inflammation Clinical Trials

Anakinra for Preterm Infants Pilot

Start date: February 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.

NCT ID: NCT04735315 Recruiting - Clinical trials for Prematurity; Extreme

Assessment of Renal Function in Adults Born Preterm: The HAPI-Kidney Study

Start date: June 26, 2021
Phase:
Study type: Observational

Every year in Canada, 1500 babies are born ≤29 weeks' gestational age (GA) and the majority survive to adulthood. Preterm birth occurs during a critical period of nephrogenesis. Antenatal and postnatal exposure to various insults may permanently disrupt normal kidney development. Indeed, preterm children have reduced nephron number and altered glomerular architecture, which may lead to glomerular hyperfiltration thus perpetuating renal damage. However, the long-term consequences of preterm birth on renal function remain under-studied. The existing reports on glomerular function have yielded contradictory results and were limited by use of imprecise estimates of glomerular filtration rate (GFR) or small sample size. Yet, a registry-based study has shown the increased risk of chronic kidney diseases (CKD) in individuals born preterm. In addition, individuals born preterm have higher blood pressure. As mechanisms for hypertension following preterm birth are being unravelled, the role of the kidneys, which is key in chronic hypertension, is to be determined. So far, we have shown a relationship between smaller kidney size and increased blood pressure. A better understanding of the early markers of kidney dysfunction following preterm birth will facilitate screening and intervention to halt progression to CKD as there are currently no long-term renal follow-up guidelines for individuals born preterm. This proposal builds on our previous works on long-term health outcomes of preterm birth and experimental model of prematurity-related conditions and renal development. We aim to assess glomerular function and renal vasoactive regulatory factors in relation to blood pressure using precise measures in a cohort of young adults born preterm ≤29 weeks versus full-term controls. We further take advantage of our previous assessment of this cohort (Health of Adults born Preterm Investigation (HAPI) - CIHR 2014-18) to evaluate changes in estimated GFR and albuminuria over a 5-year period.

NCT ID: NCT04639583 Completed - Clinical trials for Prematurity; Extreme

Use of NIRS in Preterm Population Born at Altitude

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Near-infrared spectroscopy (NIRS), is a technology that can provide continuous, non-invasive monitoring of oxygenation in tissue. The objective of this study is to obtain the cerebral regional oxygen saturation (cRSO2) in a preterm population that is born at altitude to determine if the range of "normal" values is different than those obtained at sea level.

NCT ID: NCT04545866 Active, not recruiting - Clinical trials for Respiratory Distress Syndrome

The Budesonide in Babies (BiB) Trial

BiB
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, masked, active-controlled, multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant, as compared to surfactant alone, will reduce the incidence of physiologic bronchopulmonary dysplasia (BPD) or death by 36 weeks' post-menstrual age in extremely preterm infants.

NCT ID: NCT04535375 Completed - Clinical trials for Intraventricular Hemorrhage

Sonographic QUantification of Venous Circulation In the Preterm Brain

SQUIB
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an early stage. In the future, the results of this study might be useful to select those infants for early interventions aimed at preventing brain injury. In this study we will identify the normative values of the internal cerebral vein velocity in a reference cohort of stable preterm infants. This stable group of preterm infants is defined as all preterm infants with a birth weight appropriate for gestational age, and without major complications (such as a severe intracranial hemorrhage, severe hemodynamical instability, birth asphyxia) or major congenital malformations. In this group we will identify subgroups based on moments of clinical instability (sepsis, temporary hypotension, NEC, need for invasive respiratory support) or based on outcome parameters (IVH, PVL, developmental outcomes)

NCT ID: NCT04325308 Active, not recruiting - Clinical trials for Microbial Colonization

Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

Start date: August 13, 2020
Phase: N/A
Study type: Interventional

The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.