NCT06319326

Intestinal Perfusion After Feeding in Preterm and Term Infants

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 4 Weeks
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Premature
• Necrotizing Enterocolitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-02
• Primary completion: 2024-06-30
• Completion: 2024-08-31
• First posted: 2024-03-20
• Last updated: 2024-03-20

Locations

1 site across 1 country: China