Necrotizing Enterocolitissteroids/NECNCT01156480
Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
A study testing hydrocortisone in people with Necrotizing Enterocolitis, run by Endeavor Health at 2 sites in United States.
Trial summary
Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an inflammatory necrosis of the bowels, to date no study has examined the effect of anti-inflammatory therapy on this dreaded disease once it is… Read more about this study
- Who is it for?
- Ages 0 days to 6 months
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 days to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant born at gestational age less than 34 weeks
- Birth weight less than 2500 grams
- Diagnosis of stage II or III NEC made by attending neonatologist, neonatology fellow, or pediatric hospitalist
- Legally authorized representative is able to provide written informed consent prior to the performance of an protocol-specified evaluations or procedures
- Consent can be obtained and study drug can be administered within 6 hours of diagnosis
Who cannot join
- congenital gastrointestinal anomaly
- subject is already receiving parenteral steroid therapy or subject has received parenteral steroids within one week prior to study entry
- subject has received indomethacin therapy within 48 hours prior to being diagnosed with NEC
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago Comer Childrens Hospital
Chicago, Illinois
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Official title: Anti-inflammatory Treatment at the Onset of NEC in Preterm Infants- a Pilot Study
Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an inflammatory necrosis of the bowels, to date no study has examined the effect of anti-inflammatory therapy on this dreaded disease once it is diagnosed. The investigators propose a multi-center, randomized, placebo-controlled, double-blinded pilot study to examine the effect of hydrocortisone in infants diagnosed with stages II and III NEC. The investigators will follow C-reactive protein (CRP) levels as a marker of systemic inflammation for the primary outcome in this study.
Read the detailed description
Given the extensive inflammatory response inherent to NEC, anti-inflammatory treatment may be of benefit, to both reduce inflammation and as a potential therapy to improve outcome. To date, there is no specific therapy for NEC that has been found to improve outcome, but corticosteroids have yet to be investigated in that capacity. Therefore, we propose to examine the effect of hydrocortisone for treatment of NEC in a randomized, blinded, placebo-controlled pilot study, focusing on a primary outcome of C-reactive protein levels at 3 and 7 days of therapy as a measure of inflammation. In addition, we will follow several secondary outcome measures to determine the possibility of improved outcome in those infants assigned to hydrocortisone.
The investigators hypothesize that infants diagnosed with NEC who receive hydrocortisone will have significantly lower C-reactive protein levels at 3 and 7 days of treatment versus infants who receive placebo.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- hydrocortisone, placebo
- Keywords
- necrotizing enterocolitis, NEC, premature, hydrocortisone, steroids, anti-inflammatory
- Medical subject headings
- Enterocolitis, Necrotizing, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisoneDrug
Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via IV route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
placeboDrug
Subjects in placebo group will receive a volume of placebo equal to the hydrocortisone group, on the same dosing schedule, with doses given every 8 hours via IV route for 3 days, followed by placebo every 8 hours IV for 1 day, followed by placebo every 8 hours IV for 1 day, followed by placebo every 12 hours for 1 day, followed by placebo in single dose for one day. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| hydrocortisone | Experimental | Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. Receives: Drug: hydrocortisone |
| Placebo | Placebo comparator | Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP Level
C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC.
Measured: 3 days
CRP Level
C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC
Measured: 7 days
Secondary outcomes (9)
Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)
GI failure
Measured: 36 weeks corrected gestational age
Spontaneous Intestinal Perforation
Whether or not infants had perforation.
Measured: at 36 weeks corrected gestational age
Need for Gastrointestinal Surgery
Whether or not the infants required GI surgery by 36 weeks CGA
Measured: at 36 weeks corrected gestational age
Incidence of Sepsis
Whether or not enrolled subjects had sepsis before 40 weeks CGA
Measured: at 40 weeks corrected gestational age
Time on Parenteral Nutrition
Total time on parenteral nutrition
Measured: at 40 weeks corrected gestational age
Time to Full Enteral Feeds
this will be assessed as the time needed to achieve full enteral feeds following the diagnosis of NEC. On average, it will be assessed at 40 weeks CGA, near the time of discharge, but there is a subset of infants who will not yet have achieved full enteral feeds at that time, so it may need to be assessed later than 40 weeks CGA
Measured: at 40 weeks corrected gestational age
Length of Stay
this will be assessed at the time of discharge, around 40 weeks CGA on average. A subset of infants may be discharged later than 40 weeks corrected gestational age (CGA), however, so these infants will need to have length of stay assessed later than 40 weeks CGA.
Measured: at 40 weeks corrected gestational age
Growth Velocity
Growth velocity after NEC diagnosis, in g/kg/day.
Measured: at 40 weeks CGA
Mortality
Measured: at 40 weeks corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Responsible party
- Principal investigator, Brandy Frost, Endeavor Health
- Investigators
- Brandy L Frost, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156480
- Sponsor's protocol ID
- EH09-196
- Acronym
- steroids/NEC
- Status last verified
- Aug 2020
- First submitted
- 1 Jul 2010
- Last updated
- 9 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Treatment at the Onset of NEC in Preterm Infants- a Pilot Study
- ClinicalTrials.gov ID
- NCT01156480
- Acronym / sponsor ID
- steroids/NEC / EH09-196
- Conditions
- Necrotizing Enterocolitis
- Keywords
- necrotizing enterocolitis, NEC, premature, hydrocortisone, steroids, anti-inflammatory
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- Sep 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Posted 24 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an inflammatory necrosis of the bowels, to date no study has examined the effect of anti-inflammatory therapy on this dreaded disease once it is diagnosed. The investigators propose a multi-center, randomized, placebo-controlled, double-blinded pilot study to examine the effect of hydrocortisone in infants diagnosed with stages II and III NEC. The investigators will follow C-reactive protein (CRP) levels as a marker of systemic inflammation for the primary outcome in this study.
Detailed description
Given the extensive inflammatory response inherent to NEC, anti-inflammatory treatment may be of benefit, to both reduce inflammation and as a potential therapy to improve outcome. To date, there is no specific therapy for NEC that has been found to improve outcome, but corticosteroids have yet to be investigated in that capacity. Therefore, we propose to examine the effect of hydrocortisone for treatment of NEC in a randomized, blinded, placebo-controlled pilot study, focusing on a primary outcome of C-reactive protein levels at 3 and 7 days of therapy as a measure of inflammation. In addition, we will follow several secondary outcome measures to determine the possibility of improved outcome in those infants assigned to hydrocortisone.
The investigators hypothesize that infants diagnosed with NEC who receive hydrocortisone will have significantly lower C-reactive protein levels at 3 and 7 days of treatment versus infants who receive placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrocortisone | Experimental | Drug: hydrocortisoneSubjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
| Placebo | Placebo comparator | Drug: placeboSubjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
Who may qualify
- Ages
- 0 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infant born at gestational age less than 34 weeks
- Birth weight less than 2500 grams
- Diagnosis of stage II or III NEC made by attending neonatologist, neonatology fellow, or pediatric hospitalist
- Legally authorized representative is able to provide written informed consent prior to the performance of an protocol-specified evaluations or procedures
- Consent can be obtained and study drug can be administered within 6 hours of diagnosis
Key exclusion criteria (3 listed)
- congenital gastrointestinal anomaly
- subject is already receiving parenteral steroid therapy or subject has received parenteral steroids within one week prior to study entry
- subject has received indomethacin therapy within 48 hours prior to being diagnosed with NEC
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 |
|---|---|---|
| hydrocortisoneSubjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via IV route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. | Drug | hydrocortisone |
| placeboSubjects in placebo group will receive a volume of placebo equal to the hydrocortisone group, on the same dosing schedule, with doses given every 8 hours via IV route for 3 days, followed by placebo every 8 hours IV for 1 day, followed by placebo every 8 hours IV for 1 day, followed by placebo every 12 hours for 1 day, followed by placebo in single dose for one day. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. | Drug | Placebo |
Primary outcome
CRP Level
Time frame: 3 days
C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC.
CRP Level
Time frame: 7 days
C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC
9 secondary outcomes
Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)
Time frame: 36 weeks corrected gestational age
Spontaneous Intestinal Perforation
Time frame: at 36 weeks corrected gestational age
Need for Gastrointestinal Surgery
Time frame: at 36 weeks corrected gestational age
Incidence of Sepsis
Time frame: at 40 weeks corrected gestational age
Time on Parenteral Nutrition
Time frame: at 40 weeks corrected gestational age
Time to Full Enteral Feeds
Time frame: at 40 weeks corrected gestational age
Length of Stay
Time frame: at 40 weeks corrected gestational age
Growth Velocity
Time frame: at 40 weeks CGA
Mortality
Time frame: at 40 weeks corrected gestational age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Brandy L Frost, MD principal investigator
Endeavor Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrocortisone in people with Necrotizing Enterocolitis, run by Endeavor Health at 2 sites in United States.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP Level (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2020.