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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: 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: NCT04545866 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 Recruiting - 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: NCT04294368 Recruiting - Growth Failure Clinical Trials

Targeted Fortification of Donor Breast Milk in Preterm Infants

Start date: March 9, 2020
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.

NCT ID: NCT04270240 Recruiting - Clinical trials for Patent Ductus Arteriosus

A NEW SCORING SYSTEM FOR PREDICTION OF PDA

SIMPLE
Start date: January 15, 2019
Phase:
Study type: Observational

Patent ductus arteriosus (PDA) is an important morbidity of that the diagnosis and treatment is controversy in premature infants. A number of scoring systems have been developed, including the findings of echocardiography on the diagnosis and treatment of PDA. This study aimed to develop a new clinical scoring system that will enable the rapid, standard and noninvasive evaluation of hemodynamically significant PDA earlier, without relying on echocardiographic findings in premature babies with extremely low birth weight, and to determine the role of this scoring system in early diagnosis and treatment.

NCT ID: NCT04114435 Recruiting - Clinical trials for Prematurity; Extreme

Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants

Start date: October 12, 2019
Phase:
Study type: Observational

Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study