An observational study in Intestinal Perforation and Necrotizing Enterocolitis, sponsored by Children's Hospitals and Clinics of Minnesota. Status unknown at 1 site in United States. Open to participants aged 1 Day to 16 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-09.
Sponsored by Children's Hospitals and Clinics of Minnesota · Observational
This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk. Analysis of perforation rates of all infants in the three largest participating sites shows that the majority of infants with perforation will do so prior to day of life 21. This study will target the group of infants at highest risk for IP, those with birth weight less than 1000 grams, within the time frame most likely to capture the perforation. Hypothesis: An IRT value exists that can adequately differentiate premature infants with and without intestinal perforation in the first 3 weeks of life.
At least 300 infants age 1-16 days will be enrolled. IRT values will be obtained daily through day of life 21, if the infant is already having labs drawn that day. The primary outcomes will be intestinal perforation and/or death on or before day of life 21. Each patient will be followed until death or discharge. Discharge will be defined as the release of the infant to home. Infants who are transferred to another NICU may be followed if the receiving NICU is one of the investigational sites. Transfer includes the release of the infant to outside units or other units within the same hospital. The purpose of this follow up is to obtain serial IRT values through day of life 21.
36 studies on the registry are indexed under Intestinal Perforation; 5 are open to participants now.
This study's planned enrollment of 300 is above the median of 203 across 20 observational studies indexed under Intestinal Perforation.
Browse Intestinal Perforation studies →Children's Hospitals and Clinics of Minnesota is the lead sponsor of 49 studies on the registry; 2 are open to participants now.
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Premature infants less than 1000 grams, age 1-16 days
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight less than 1000 grams, age 1 - 16 days.
To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation.
Time frame: 3 years
Determine if factors other than intestinal perforation affect serum IRT.
Time frame: 3 years
This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Children's Hospitals and Clinics of Minnesota