Necrotizing EnterocolitisNCT04344639
Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey
An observational study of Necrotizing Enterocolitis, run by Turkish Neonatal Society at 2 sites in Turkey (Türkiye).
Trial summary
Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- the incidence, risk factors, treatment, prognosis of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our country
- How many people
- 500 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Apr 2020
- 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 1 day to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Newborns diagnosed with NEC in neonatal intensive care units.
Who may be able to join
- Newborns diagnosed with NEC in neonatal intensive care units
Who cannot join
- Major congenital anomaly,
- congenital heart disease (except for atrial septal defect, ventricular septal defect, patent ductus arteriosus)
- Chromosomal anomaly
- Inherited metabolic disease
- Hypoxic ischemic encephalopathy
- Newborns who died within the first 48 hours of life
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Tolga Hasan Çelik, MD
Ankara, 06100
Tolga Hasan Çelik
Ankara, 06100
About this study
Official title: Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey: A Prospective Multicentre Study
Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Although it is more common in premature infants, it is also seen in term babies when the intestine is ischemic. Although the major problem in premature babies is the immaturity of the intestine, many factors contributing to immaturity play a role in the pathogenesis of NEC.
Read the detailed description
Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Although it is more common in premature infants, it is also seen in term babies when the intestine is ischemic. Although the major problem in premature babies is the immaturity of the intestine, many factors contributing to immaturity play a role in the pathogenesis of NEC.
With this study project, which is planned as a national multicenter prospective study, the incidence of necrotizing enterocolitis in newborn infants born in neonatal intensive care units in our country and the risk factors associated with the NEC, especially the detailed feeding history of the patient (when the first feeding is nourished, antibiotics and other treatments that are being used). Most epidemiological data such as the most common stage of the disease, treatment, prognosis, comparison with the data of other countries will provide important information for the neonatal health of our country.
The aim of this study was to determine the factors affecting the emergence of NEC in neonatal intensive care units and to determine the frequency of NEC.
Study Hypothesis: Delayed enteral feeding, intensive use of antibiotics and nutrients other than breast milk increase the incidence of necrotizing enterocolitis.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- the incidence, risk factors, treatment, prognosis of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our country
- Keywords
- neonate, newborn, premature, necrotizing enterocolitis, neonatal intensive care unit, infant, incidence, risk factors, Turkey
- 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.
the incidence, risk factors, treatment, prognosis of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our countryOther
With this project, which is planned as a national multicenter prospective study, the incidence of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our country and the risk factors associated with the disease, especially the detailed feeding history of the patient (when the first feeding is nourished, antibiotics and other treatments that are being used). Most epidemiological data such as the most common stage of the disease, treatment, prognosis, comparison with the data of other countries will provide important information for the neonatal health of our country.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Necrotizing Enterocolitis
Incidence: frequency of NEC during study period
Measured: 1 year
Risk factors for mild and severe necrotizing enterocolitis
erytrocyte/FFP/trombocyte transfusions,PDA closing therapy, umbilical artery catheterisation,
Measured: 1 year
Initiation of enteral feeding time, choice of breastfeeding or formula
nutrition: breastfeeding of formula, delayed enteral feeding
Measured: 1 year
Meconium discharge time
meconium discharge time (hour)
Measured: 1 year
probiotic usage
probiotic usage, type of probiotic preparation
Measured: 1 year
severity of necrotizing enrerocolitis
Grade of NEC disease according to modified Bell Criteria
Measured: 1 year
Secondary outcomes (1)
Prognosis
complications: intestinal perforation, requirement of surgery, short bowell syndrome), mortality rate.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Neonatal Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tolga Hasan Çelik, MD, Hacettepe University
- Investigators
- Tolga H Çelik, MD, Principal investigator, Hacettepe University Faculty of Medicine Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344639
- Sponsor's protocol ID
- TurkishNECStudyGroup
- Status last verified
- Apr 2020
- First submitted
- 5 Mar 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study project is planned as a national multi-center study. This study will be carried out through a Web Based Multicenter Work System, which was formed by the Turkish Neonatal Society.
Publications
Neu J. Necrotizing enterocolitis. World Rev Nutr Diet. 2014;110:253-63. doi: 10.1159/000358474. Epub 2014 Apr 11.
PubMed 24751635Lim JC, Golden JM, Ford HR. Pathogenesis of neonatal necrotizing enterocolitis. Pediatr Surg Int. 2015 Jun;31(6):509-18. doi: 10.1007/s00383-015-3697-9. Epub 2015 Apr 9.
PubMed 25854935Kasivajjula H, Maheshwari A. Pathophysiology and current management of necrotizing enterocolitis. Indian J Pediatr. 2014 May;81(5):489-97. doi: 10.1007/s12098-014-1388-5. Epub 2014 Mar 22.
PubMed 24652270Niemarkt HJ, de Meij TG, van de Velde ME, van der Schee MP, van Goudoever JB, Kramer BW, Andriessen P, de Boer NK. Necrotizing enterocolitis: a clinical review on diagnostic biomarkers and the role of the intestinal microbiota. Inflamm Bowel Dis. 2015 Feb;21(2):436-44. doi: 10.1097/MIB.0000000000000184.
PubMed 25268636
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey: A Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT04344639
- Acronym / sponsor ID
- TurkishNECStudyGroup
- Conditions
- Necrotizing Enterocolitis
- Keywords
- neonate, newborn, premature, necrotizing enterocolitis, neonatal intensive care unit, infant, incidence, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Turkish Neonatal SocietyUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 14 Apr 2020 (actual)
- 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.
Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Although it is more common in premature infants, it is also seen in term babies when the intestine is ischemic. Although the major problem in premature babies is the immaturity of the intestine, many factors contributing to immaturity play a role in the pathogenesis of NEC.
Detailed description
Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Although it is more common in premature infants, it is also seen in term babies when the intestine is ischemic. Although the major problem in premature babies is the immaturity of the intestine, many factors contributing to immaturity play a role in the pathogenesis of NEC.
With this study project, which is planned as a national multicenter prospective study, the incidence of necrotizing enterocolitis in newborn infants born in neonatal intensive care units in our country and the risk factors associated with the NEC, especially the detailed feeding history of the patient (when the first feeding is nourished, antibiotics and other treatments that are being used). Most epidemiological data such as the most common stage of the disease, treatment, prognosis, comparison with the data of other countries will provide important information for the neonatal health of our country.
The aim of this study was to determine the factors affecting the emergence of NEC in neonatal intensive care units and to determine the frequency of NEC.
Study Hypothesis: Delayed enteral feeding, intensive use of antibiotics and nutrients other than breast milk increase the incidence of necrotizing enterocolitis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns diagnosed with NEC in neonatal intensive care units.
Key inclusion criteria (1 listed)
- Newborns diagnosed with NEC in neonatal intensive care units
Key exclusion criteria (6 listed)
- Major congenital anomaly,
- congenital heart disease (except for atrial septal defect, ventricular septal defect, patent ductus arteriosus)
- Chromosomal anomaly
- Inherited metabolic disease
- Hypoxic ischemic encephalopathy
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 |
|---|---|---|
| the incidence, risk factors, treatment, prognosis of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our countryWith this project, which is planned as a national multicenter prospective study, the incidence of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our country and the risk factors associated with the disease, especially the detailed feeding history of the patient (when the first feeding is nourished, antibiotics and other treatments that are being used). Most epidemiological data such as the most common stage of the disease, treatment, prognosis, comparison with the data of other countries will provide important information for the neonatal health of our country. | Other | – |
Primary outcome
Incidence of Necrotizing Enterocolitis
Time frame: 1 year
Incidence: frequency of NEC during study period
Risk factors for mild and severe necrotizing enterocolitis
Time frame: 1 year
erytrocyte/FFP/trombocyte transfusions,PDA closing therapy, umbilical artery catheterisation,
Initiation of enteral feeding time, choice of breastfeeding or formula
Time frame: 1 year
nutrition: breastfeeding of formula, delayed enteral feeding
Meconium discharge time
Time frame: 1 year
meconium discharge time (hour)
probiotic usage
Time frame: 1 year
probiotic usage, type of probiotic preparation
severity of necrotizing enrerocolitis
Time frame: 1 year
Grade of NEC disease according to modified Bell Criteria
1 secondary outcome
Prognosis
Time frame: 1 year
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 14 Apr 2020.
- Results publication: PubMed 24751635Neu J. Necrotizing enterocolitis. World Rev Nutr Diet. 2014;110:253-63. doi: 10.1159/000358474. Epub 2014 Apr 11.
- Results publication: PubMed 25854935Lim JC, Golden JM, Ford HR. Pathogenesis of neonatal necrotizing enterocolitis. Pediatr Surg Int. 2015 Jun;31(6):509-18. doi: 10.1007/s00383-015-3697-9. Epub 2015 Apr 9.
- Results publication: PubMed 24652270Kasivajjula H, Maheshwari A. Pathophysiology and current management of necrotizing enterocolitis. Indian J Pediatr. 2014 May;81(5):489-97. doi: 10.1007/s12098-014-1388-5. Epub 2014 Mar 22.
- Results publication: PubMed 25268636Niemarkt HJ, de Meij TG, van de Velde ME, van der Schee MP, van Goudoever JB, Kramer BW, Andriessen P, de Boer NK. Necrotizing enterocolitis: a clinical review on diagnostic biomarkers and the role of the intestinal microbiota. Inflamm Bowel Dis. 2015 Feb;21(2):436-44. doi: 10.1097/MIB.0000000000000184.
- Individual participant dataSharing planned: No. This study project is planned as a national multi-center study. This study will be carried out through a Web Based Multicenter Work System, which was formed by the Turkish Neonatal Society.
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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.
Tolga H Çelik, MD principal investigator
Hacettepe University Faculty of Medicine Department of Pediatrics
2 sites 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 Turkish Neonatal Society at 2 sites in Turkey (Türkiye).
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 1 inclusion and 6 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 14 Apr 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 Turkey (Türkiye). 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?
Incidence of Necrotizing Enterocolitis (time frame: 1 year). The study lists 6 primary outcomes in all. 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 NCT04344639, which also lists 4 linked publications.
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 14 Apr 2020.