PrematureNCT06319326
Intestinal Perfusion After Feeding in Preterm and Term Infants
An observational study of Premature and Necrotizing Enterocolitis, run by The Hospital for Sick Children at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature, Necrotizing Enterocolitis
- What is being tested?
- Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2024to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Preterm infants (≤33 weeks gestational age) of any birth weight receiving full bolus enteral feeding.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University (Xiamen Branch)
Xiamen, Fujian, 361000
Haitao Zhu, MD, +86-592-2529586, haitao_zhu@fudan.edu.cn
Haitao Zhu, MD
About this study
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.
Read the 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
- Being tested
- Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.
- Keywords
- intestinal perfusion, postprandial intestinal perfusion, Color Doppler abdominal ultrasound
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.Other
Also called No intervention.
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.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants | Preterm infants (≤33 weeks gestational age) of any birth weight receiving full bolus enteral feeding, aged 1-4 weeks. Receives: 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. Receives: Other: Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured immediately before and 60 minutes after feeding
Secondary outcomes (1)
Bowel wall perfusion
Color Doppler abdominal ultrasound is used to measure changes in peripheral perfusion of the bowel wall pre- and post-prandially.
Measured: Measured immediately before and 60 minutes after feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start2 Apr 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Children's Hospital
- Responsible party
- Principal investigator, Agostino Pierro, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319326
- Sponsor's protocol ID
- Postfeed Intestinal Perfusion
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31704804Chen 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.
PubMed 27815640
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Perfusion After Feeding in Preterm and Term Infants
- ClinicalTrials.gov ID
- NCT06319326
- Acronym / sponsor ID
- Postfeed Intestinal Perfusion
- Conditions
- Premature, Necrotizing Enterocolitis
- Keywords
- intestinal perfusion, postprandial intestinal perfusion, Color Doppler abdominal ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Xiamen Children's Hospital
- Study start
- 2 Apr 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm infants | – | Other: Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.Preterm infants (≤33 weeks gestational age) of any birth weight receiving full bolus enteral feeding, aged 1-4 weeks. |
| Term infants | – | Other: Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.Term infants of any birth weight aged 1-4 weeks. |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Preterm infants (≤33 weeks gestational age) of any birth weight receiving full bolus enteral feeding.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.Also: No intervention.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. | Other | Preterm infants, Term infants |
Primary outcome
Time-averaged mean velocity of the superior mesenteric artery
Time frame: Measured immediately before and 60 minutes after feeding
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.
1 secondary outcome
Bowel wall perfusion
Time frame: Measured immediately before and 60 minutes after feeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 31704804Chen 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.
- Background: PubMed 27815640Chen 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.
- Individual participant dataSharing planned: No
Related trials for Premature
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature and Necrotizing Enterocolitis, run by The Hospital for Sick Children at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agostino Pierro, OBE, MD, FRCS, FAAP (4168137654 ext. 309350, agostino.pierro@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-averaged mean velocity of the superior mesenteric artery (time frame: Measured immediately before and 60 minutes after feeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06319326, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.