Necrotizing EnterocolitisNCT01670916
Probiotics to Prevent NEC - a Historical Control Study
An observational study of Necrotizing Enterocolitis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Probiotics is given routinely to infants admitted to the department of neonatology during the first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical records. Read more about this study
- Who is it for?
- Ages Up to 3 days
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- probiotics
- Type of treatment
- Pill or oral medicine
- How many people
- 714 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Jun 2013
- 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 3 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborn infants admitted for special or intensive care
Who may be able to join
- Gestational age less than 30 weeks
- Admission during the first 3 days of life
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study
Probiotics is given routinely to infants admitted to the department of neonatology during the first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1 March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009 will be compared.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- probiotics
- Keywords
- Necrotizing enterocolitis, Probiotics, Preterm, Infant
- 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.
probioticsDietary supplement
Also called Bifiform, Ferrosan A/S, Idoform, Ferronan A/S
Capsule with 1 x 109 Lactobacillus rhamnosus GG and 1 x 108 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Capsule with 1 x 109 Lactobacillus rhamnosus GG and 1 x 108 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube. Receives: Dietary Supplement: probiotics | |
| Control | Probiotics never given |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEC
The clinical records of infants who had a discharge diagnosis of necrotizing enterocolitis are selected. Records of infants who had a prescription of metronidazole for a non-preventive purpose is added. The clinical records are abstracted. The abstracts and X-rays are presented to a review board that are blinded to the period of birth. The board classifies the cases as NEC-I, NEC-II, NEC-III, focal intestinal perforation, and OTHER.
NEC-II/III is the primary outcome.
Measured: From birth until discharge home
Secondary outcomes (2)
Death with NEC
Death with a review board classification of NEC-II/III
Measured: Birth to discharge home
Death
Measured: Birth to discharge home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startMar 2010
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Case-control
- Enrolment
- 714 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gorm Greisen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670916
- Sponsor's protocol ID
- RHNEO-NEC01
- Status last verified
- Sep 2013
- First submitted
- 17 Aug 2012
- Last updated
- 7 Oct 2013
- Results posted
- No
Publications
Lambaek ID, Fonnest G, Gormsen M, Brok J, Greisen G. Probiotics to prevent necrotising enterocolitis in very preterm infants. Dan Med J. 2016 Mar;63(3):A5203.
PubMed 26931192
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study
- ClinicalTrials.gov ID
- NCT01670916
- Acronym / sponsor ID
- RHNEO-NEC01
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Necrotizing enterocolitis, Probiotics, Preterm, Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 714 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Aug 2012 (estimated)
- 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.
Probiotics is given routinely to infants admitted to the department of neonatology during the first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1 March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009 will be compared.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | – | Dietary Supplement: probioticsCapsule with 1 x 109 Lactobacillus rhamnosus GG and 1 x 108 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube. |
| Control | – | –Probiotics never given |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn infants admitted for special or intensive care
Key inclusion criteria (2 listed)
- Gestational age less than 30 weeks
- Admission during the first 3 days of life
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| probioticsAlso: Bifiform, Ferrosan A/S, Idoform, Ferronan A/SCapsule with 1 x 109 Lactobacillus rhamnosus GG and 1 x 108 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube. | Dietary supplement | Probiotics |
Primary outcome
NEC
Time frame: From birth until discharge home
The clinical records of infants who had a discharge diagnosis of necrotizing enterocolitis are selected. Records of infants who had a prescription of metronidazole for a non-preventive purpose is added. The clinical records are abstracted. The abstracts and X-rays are presented to a review board that are blinded to the period of birth. The board classifies the cases as NEC-I, NEC-II, NEC-III, focal intestinal perforation, and OTHER. NEC-II/III is the primary outcome.
2 secondary outcomes
Death with NEC
Time frame: Birth to discharge home
Death
Time frame: Birth to discharge home
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
- Derived from this study: PubMed 26931192Lambaek ID, Fonnest G, Gormsen M, Brok J, Greisen G. Probiotics to prevent necrotising enterocolitis in very preterm infants. Dan Med J. 2016 Mar;63(3):A5203.
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Necrotizing Enterocolitis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Necrotizing Enterocolitis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 7 Oct 2013. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NEC (time frame: From birth until discharge home). 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 NCT01670916, which also lists 1 linked publication.
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 7 Oct 2013.