Intestinal Perfusion After Feeding in Preterm and Term Infants

NCT06319326 | Not Yet Recruiting

• 1 other identifier: Postfeed Intestinal Perfusion
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature; Necrotizing Enterocolitis

Keywords

intestinal perfusion; postprandial intestinal perfusion; Color Doppler abdominal ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bowel wall perfusion

  Measured immediately before and 60 minutes after feeding

Study Arms (2)

Preterm infants

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

Term infants of any birth weight aged 1-4 weeks.

Other: Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.

Interventions

Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding. OTHER

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.

Preterm infants; Term infants

Eligibility Criteria

• Age: Up to 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 2 cohorts: * Preterm infants (≤33 weeks gestational age at birth) of any birth weight receiving full bolus enteral feeding. * Term infants of any birth weight aged 1-4 weeks. 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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Xiamen Children's Hospital: collaborator

Study Sites (1)

Children's Hospital of Fudan University (Xiamen Branch)

Xiamen, Fujian, 361000, China

Location

Related 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.

  PMID: 31704804 BACKGROUND

• 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.

  PMID: 27815640 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing

Interventions

Postprandial Period

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Agostino Pierro, OBE, MD, FRCS, FAAP

CONTACT

4168137654; agostino.pierro@sickkids.ca

Niloofar Ganji, BSc, MSc

CONTACT

6478702781; niloofar.ganji@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 20, 2024
• Study Start: April 2, 2024
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)