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โ† Trials
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Gut Permeability and Microbiome in Preterm Infants

RecruitingPhase 1Ages any - 4 DaysAllUniversity of Maryland, Baltimore
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In plain words

What the trial is, and whether it could suit you

NEC, a life-threatening, GI emergency characterized by increased IP, affects approximately 7 to 10% of preterm neonates, and typically occurs within 7 to 14 days of birth with mortality as high as 30-50%. NEC symptoms mainly involve GI dysfunction, such as abdominal distension and feeding intolerance, but the presentation can be non-specific with few warning signs. Current therapies may be invasive, including surgical interventions that are often ineffective due to the rapid progression of the disease. Prematurity is the greatest risk factor for development of NEC due to physiological immaturity of the GI tract and altered levels of the normal GI microbiota. Several studies suggest that the initiation of an intense systemic and local inflammatory cascade leads to intestinal necrosis . Antenatal exposure to infection/inflammation may predispose the developing intestinal mucosa to subseque

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: \<5 days Gestational age 24-32 weeks Exclusion Criteria: Nonviable or planned withdrawal of care * Significant GI dysfunction (e.g. heme-positive stools, abdominal distension (girth \>2 cm baseline), or bilious emesis/ aspirates. * Triplet or higher order multiple * Severe asphyxia * Lethal chromosome abnormalities * Cyanotic congenital heart disease * Intestinal atresia or perforation * Abdominal wall defects * Known galactosemia or other galactose intolerance
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What it tests

  • measurement of intestinal permeability
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Where

1 site
University of Maryland
Baltimore, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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