Trial · NCT01156480
Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
NCT01156480, Not applicable, Terminated, Endeavor Health; results first posted 2014-03-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants. Trials, record NCT01156480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01156480
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
- NCT number
- NCT01156480
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 2 participants, actual
- Lead sponsor
- Endeavor Health
- Conditions
- Necrotizing Enterocolitis
- Interventions
- hydrocortisone, placebo
- First posted
- 2010-07-02
- Last updated
- 2020-09-09
- Results first posted
- 2014-03-24
- Limitations and caveats
This study was terminated due to low enrollment. We had a drop in our incidence of NEC, so there were very few eligible infants. One subject that was enrolled was soon thereafter thought NOT to have NEC, so that subject never received study drug.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CRP Level | 3 days | C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC. |
| Primary | CRP Level | 7 days | C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC |
| Secondary | Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age) | 36 weeks corrected gestational age | GI failure |
| Secondary | Spontaneous Intestinal Perforation | at 36 weeks corrected gestational age | Whether or not infants had perforation. |
| Secondary | Need for Gastrointestinal Surgery | at 36 weeks corrected gestational age | Whether or not the infants required GI surgery by 36 weeks CGA |
| Secondary | Incidence of Sepsis | at 40 weeks corrected gestational age | Whether or not enrolled subjects had sepsis before 40 weeks CGA |
| Secondary | Time on Parenteral Nutrition | at 40 weeks corrected gestational age | Total time on parenteral nutrition |
| Secondary | Time to Full Enteral Feeds | at 40 weeks corrected gestational age | 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 |
| Secondary | Length of Stay | at 40 weeks corrected gestational age | 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. |
| Secondary | Growth Velocity | at 40 weeks CGA | Growth velocity after NEC diagnosis, in g/kg/day. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | CRP Level | 3 days | This study was terminated due to low enrollment. We had a drop in our incidence of NEC, so there were very few eligible infants. One subject that was enrolled was soon thereafter thought NOT to have NEC, so that subject never received study drug. | mg/L | NUMBER |
| PRIMARY | CRP Level | 7 days | This study was terminated due to low enrollment. We had a drop in our incidence of NEC, so there were very few eligible infants. One subject that was enrolled was soon thereafter thought NOT to have NEC, so that subject never received study drug. | mg/L | NUMBER |
| SECONDARY | Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age) | 36 weeks corrected gestational age | The one enrolled infant did not have GI failure at 36 weeks CGA. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Spontaneous Intestinal Perforation | at 36 weeks corrected gestational age | Only 1 infant enrolled (placebo group) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Need for Gastrointestinal Surgery | at 36 weeks corrected gestational age | We only enrolled one subject (placebo group) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Sepsis | at 40 weeks corrected gestational age | We only enrolled one subject (placebo group). She did have fungal sepsis). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time on Parenteral Nutrition | at 40 weeks corrected gestational age | Only one subject was enrolled (placebo group) | days | NUMBER |
| SECONDARY | Time to Full Enteral Feeds | at 40 weeks corrected gestational age | We only enrolled one subject into the placebo group. | days | NUMBER |
| SECONDARY | Length of Stay | at 40 weeks corrected gestational age | only one subject enrolled into placebo group | days | NUMBER |
| SECONDARY | Growth Velocity | at 40 weeks CGA | We only enrolled one subject into the placebo group. | grams/kg/d | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| CRP Level | Placebo | 25.3 | mg/L | ||
| CRP Level | Placebo | 6.7 | mg/L | ||
| Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age) | Placebo | 0 | Participants | ||
| Spontaneous Intestinal Perforation | Placebo | 0 | Participants | ||
| Need for Gastrointestinal Surgery | Placebo | 0 | Participants | ||
| Incidence of Sepsis | Placebo | 1 | Participants | ||
| Time on Parenteral Nutrition | Placebo | 39 | days | ||
| Time to Full Enteral Feeds | Placebo | 35 | days | ||
| Length of Stay | Placebo | 141 | days | ||
| Growth Velocity | Placebo | 14.4 | grams/kg/d |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydrocortisone | 0 | |
| Overall Study | STARTED | Placebo | 2 | |
| Overall Study | COMPLETED | Hydrocortisone | 0 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Hydrocortisone | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydrocortisone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Hydrocortisone | 0 | 0 |
| Total, other adverse events | Placebo | 0 | 1 |
| Total, serious adverse events | Hydrocortisone | 0 | 0 |
| Total, serious adverse events | Placebo | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01156480
GET https://conductscience.org/api/trials/v1/NCT01156480/registered