CLINICAL TRIAL

Treatment for Necrotizing Enterocolitis (NEC)

High Risk
Recruiting · < 18 · All Sexes · Halifax, Canada

WithHolding Enteral Feeds Around Blood Transfusion (International)

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About the trial for Necrotizing Enterocolitis (NEC)

Eligible Conditions
Necrotizing Enterocolitis (NEC) · Enterocolitis, Necrotizing · Enterocolitis

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Withholding feeds around transfusion
OTHER
Control Group 2
Continued feeds around transfusion
OTHER

Eligibility

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
1. Preterm birth at <30+0 gestational weeks + days
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From birth to date of discharge home
Screening: ~3 weeks
Treatment: Varies
Reporting: From birth to date of discharge home
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From birth to date of discharge home.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 12 secondary outcomes in patients with Necrotizing Enterocolitis (NEC). Measurement will happen over the course of From birth to date of discharge home.

Duration of hospital stay
FROM BIRTH TO DATE OF DISCHARGE HOME
Total duration of neonatal care in days including all levels of care (intensive care, high dependency care, special care and ordinary care)
FROM BIRTH TO DATE OF DISCHARGE HOME
Bronchopulmonary Dysplasia (BPD)/Chronic Lung Disease
AT 36 WEEKS POSTMENSTRUAL AGE
Requiring respiratory support at 36 weeks gestation
AT 36 WEEKS POSTMENSTRUAL AGE
Retinopathy of prematurity (ROP)
FROM RANDOMIZATION TO 40 WEEKS POSTMENSTRUAL AGE
ROP requiring treatment
FROM RANDOMIZATION TO 40 WEEKS POSTMENSTRUAL AGE
Death
FROM RANDOMIZATION TO 40 WEEKS POSTMENSTRUAL AGE
All-cause mortality
FROM RANDOMIZATION TO 40 WEEKS POSTMENSTRUAL AGE
NEC Stage II
FROM RANDOMIZATION TO 40 WEEKS POSTMENSTRUAL AGE
NEC stage II or more after the first transfusion (modified Bell staging criteria) - Clinical signs and symptoms plus pneumatosis or portal/hepatic air diagnosed by x-ray or other imaging techniques
FROM RANDOMIZATION TO 40 WEEKS POSTMENSTRUAL AGE
Late onset sepsis
FROM RANDOMIZATION TO 40 WEEKS POSTMENSTRUAL AGE
Culture positive sepsis, onset after 72 hours of life
FROM RANDOMIZATION TO 40 WEEKS POSTMENSTRUAL AGE
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Who is running the study

Principal Investigator
D. B. S.
Dr. Balpreet Singh, MD
IWK Health Centre

Patient Q & A Section

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Other questions from users

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Necrotizing Enterocolitis (NEC) by sharing your contact details with the study coordinator.