An observational study in Premature and Necrotizing Enterocolitis, sponsored by The Hospital for Sick Children. Not yet recruiting at 1 site in China. Open to participants aged Up to 4 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by The Hospital for Sick Children · Observational
This is a pilot exploratory observational prospective cohort phase I study. In this study, we will gather preliminary data to evaluate (i) the magnitude of changes in blood flow in the bowel before and after feeding and (ii) the differences between preterm and term infants.
Necrotizing enterocolitis (NEC) is the most devastating intestinal disease which remains a major unsolved clinical challenge in neonatology. NEC is predominantly a disease of preterm or extremely preterm infants. NEC results in high mortality, neurodevelopmental impairment, intestinal failure, and reduced quality of life.
Prematurity and enteral feeding are two of the most important risk factors for NEC. More than 90% of infants with NEC have been enterally fed, suggesting that feeding is an important priming step in making the intestine vulnerable to NEC. Absorption of nutrients is energy-consuming and results in an increased oxygen demand after feeding, followed by an increase in intestinal blood flow above baseline (known as postprandial hyperemia). Our preclinical studies have shown an intriguing discovery, that prematurity is associated with a remarkably reduced intestinal response to feeding, which predisposes the intestine to NEC.
However, there is lack of reliable clinical evidence to compare the magnitude of difference in postprandial intestinal blood flow in human preterm versus term infants. If preterm infants do in fact demonstrate a diminished intestinal blood flow response to feeding, this will shed light on the need for interventions in the feeding protocol of this vulnerable population to prevent the development of NEC.
This study is a phase I exploratory prospective cohort study. We will gather preliminary data to evaluate (i) the magnitude of changes in blood flow in the bowel before and after feeding and (ii) the differences between preterm and term infants.
In a cohort of 20 patients (10 preterm, 10 term), we will evaluate feeding-related perfusion of the superior mesenteric artery and bowel wall immediately before and 60-minutes after feeding.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 20 is below the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population consists of 2 cohorts:
The sources of preterm infants are level III/IV neonatal intensive care units at Xiamen Children's Hospital and the Hospital for Sick Children. The source of the cohort of term infants will be Level II neonatal ward at Children's Hospital of Fudan University (Xiamen Branch), Xiamen Children's Hospital and the Hospital for Sick Children.
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Exclusion Criteria:
Preterm infants (≤33 weeks gestational age) of any birth weight receiving full bolus enteral feeding, aged 1-4 weeks.
Other: Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.
Term infants of any birth weight aged 1-4 weeks.
Other: Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.
This is an observation study involving measurement of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding. No intervention is given to study participants.
Also known as: No intervention.
Time-averaged mean velocity of the superior mesenteric artery
Abdominal ultrasound is used to measure the percent change in time-averaged mean velocity (TAMV) of the superior mesenteric artery (SMA) between pre and post-prandial assessments.
Time frame: Measured immediately before and 60 minutes after feeding
Bowel wall perfusion
Color Doppler abdominal ultrasound is used to measure changes in peripheral perfusion of the bowel wall pre- and post-prandially.
Time frame: Measured immediately before and 60 minutes after feeding
Plan to share: No
Start is estimated for Apr 2024; primary completion for Jun 2024, 2 months later.
Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's planned 2 months is below that.
Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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