Intestinal Perfusion After Feeding in Preterm and Term Infants

Necrotizing Enterocolitis Clinical Trial

Official title:

Intestinal Perfusion After Feeding in Preterm and Term Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319326
• Other study ID #: Postfeed Intestinal Perfusion
• Status: Not yet recruiting
• Start date: April 2, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: The Hospital for Sick Children
• Contact: Agostino Pierro, OBE, MD, FRCS, FAAP
• Phone: 4168137654
• Email: agostino.pierro[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Weeks

Eligibility

Inclusion Criteria:

• Preterm infants (=33 weeks gestational age) of any birth weight receiving full bolus enteral feeding.

Exclusion Criteria:

• Neonates receiving bolus enteral feeds lasting >30 minutes or continuous enteral feeds will be excluded to avoid overlapping or close timing between pre- and post-prandial intestinal perfusion measurements.

• Large patent ductus arteriosus (PDA)

• Major congenital malformations

• Suspected genetic syndrome

• Ssuspected or confirmed infection

• Fraction of inspired oxygen of =0.60 at enrollment

• Confirmed diagnosis of necrotizing enterocolitis diagnosis. NEC will be diagnosed when at least two of the following clinical signs and one radiological sign will be present: (i) Clinical signs (1. abdominal distension; 2. abdominal tenderness; 3. abdominal discoloration; 4. blood in stool). (ii) Radiological signs (1. Pneumoperitoneum; 2. pneumatosis; 3. portal venous gas).

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Premature

Intervention

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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University (Xiamen Branch)	Xiamen	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Xiamen Children's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Chen Y, Koike Y, Chi L, Ahmed A, Miyake H, Li B, Lee C, Delgado-Olguin P, Pierro A. Formula feeding and immature gut microcirculation promote intestinal hypoxia, leading to necrotizing enterocolitis. Dis Model Mech. 2019 Dec 9;12(12):dmm040998. doi: 10.1242/dmm.040998. — View Citation

Chen Y, Koike Y, Miyake H, Li B, Lee C, Hock A, Zani A, Pierro A. Formula feeding and systemic hypoxia synergistically induce intestinal hypoxia in experimental necrotizing enterocolitis. Pediatr Surg Int. 2016 Dec;32(12):1115-1119. doi: 10.1007/s00383-016-3997-8. Epub 2016 Nov 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured immediately before and 60 minutes after feeding
Secondary	Bowel wall perfusion	Color Doppler abdominal ultrasound is used to measure changes in peripheral perfusion of the bowel wall pre- and post-prandially.	Measured immediately before and 60 minutes after feeding