Necrotizing EnterocolitisNOR-NECNCT06757582
Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up
An observational study of Necrotizing Enterocolitis and Intestinal Perforation, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Necrotizing Enterocolitis, Intestinal Perforation, Premature Infant Disease
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2025to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Cases and Controls will be identified through the Norwegian Neonatal Network.
Who may be able to join
- Case: All Norwegian very preterm infants (gestational age (GA) < 32 weeks) born during the 6-year period 2008-2013, diagnosed with surgical NEC or bowel perforation and surviving up to one year of age will be invited to participate as cases.
- Controls: For each case we will invite two controls matched for important clinical characteristics (e.g. sex, GA, clinical illness score, intracranial pathology, need for oxygen at discharge etc.).
Who cannot join
- not signing informed consent scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall. Some preterm infants also develop spontaneous intestinal perforations (SIP) without the classical bowel inflammation/necrosis seen in NEC. NEC and SIP can be challenging to differentiate. Severe cases of both conditions require surgery and often bowel resection, but mortality due to SIP seems lower.
Studies looking at "long-term prognosis" of infants with NEC and bowel perforation have mainly assessed outcome until 2-7 years of age. The primary school years is a vulnerable period for ex-preterm children. Disruption in learning and social integration is of great importance for their quality of life (QoL), but little data exist in this age group. Moreover, nutritional deficits (e.g. cobalamin- or iron-deficiency may impact cognitive development, but this has not been investigated in this "high-risk" population in school age. Authors of a recent systematic review on gastrointestinal sequel after NEC-surgery thus called for "more high-quality studies assessing long-term follow-up".
In this project we will study the long-term impact of surgery for NEC and bowel perforation in preterm infants, both with a quality of life (QoL) perspective and with a focus on development, growth, nutrition and persistent gastrointestinal problems.
Read the detailed description
INTRODUCTION
Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall. The incidence of NEC is inversely related to birth weight and gestational age (GA), with the majority of affected being very preterm infants (GA < 32 weeks), and in particular extremely preterm infants (GA < 28 weeks). In Scandinavia, the rates of NEC in extremely preterm infants is 6-9% (1-3). NEC is a devastating condition and one of the four main causes of mortality in neonatal intensive care units (NICUs) (4). Some preterm infants also develop spontaneous intestinal perforations (SIP) without the classical bowel inflammation/necrosis seen in NEC. NEC and SIP can be challenging to differentiate. Severe cases of both conditions require surgery and often bowel resection, but mortality due to SIP seems lower (5).
The clinical onset of NEC is usually in the second or third week of life. Typical symptoms and signs are a distended abdomen, periumbilical erythema, bloody stools, feeding intolerance and a generally unstable infant. However, the signs are non-specific, and the diagnosis is usually based on radiographic findings such as intramural bowel gas (6, 17, 18). The severity is classified by modified Bells criteria (18, 19). Stage I refers to suspected, but unconfirmed NEC. Stage II is radiographically confirmed NEC requiring medical therapy including broad-spectrum antibiotics and supportive care. Stage III patients demonstrate clinical signs of bowel necrosis, peritonitis, and septic shock, or radiographic findings of bowel perforation. These patients often receive surgery in addition to intensive care. The mortality rate of NEC is between 20-40%; highest in immature infants and/or stage III disease (20, 21).
Survivors of severe NEC (stage III) require long and often very intensive medical therapy that cause suffering for both patients and their families (18, 20). Moreover, medical therapy of patients with NEC requires huge resources for the neonatal unit and the health care system (20). Those who survive NEC have an increased risk of later gut-associated problems (e.g. short bowel syndrome and strictures) (18, 22), and neurodevelopmental disability (20, 23). Similar results have been observed in follow-up studies after SIP, but less data is available for this condition (23).
Although significant progress has been made in our understanding of NEC/SIP over the last decade, many questions remain regarding the long-term prognosis and optimal follow-up.
Studies looking at "long-term prognosis" of infants with NEC and bowel perforation have mainly assessed outcome until 2-7 years of age (20, 24). The primary school years is a vulnerable period for ex-preterm children. Disruption in learning and social integration is of great importance for their quality of life (QoL), but little data exist in this age group (25). Moreover, nutritional deficits (e.g. cobalamin- or iron-deficiency (26, 27) may impact cognitive development, but this has not been investigated in this "high-risk" population in school age. Authors of a recent systematic review on gastrointestinal sequel after NEC-surgery thus called for "more high-quality studies assessing long-term follow-up" (28).
In this project we will study the long-term impact of surgery for NEC and bowel perforation in preterm infants, both with a quality of life (QoL) perspective and with a focus on development, growth, nutrition and persistent gastrointestinal problems.
AIM
to collect long-term follow-up data on QoL, growth, development, biochemical nutritional status and persistent gastrointestinal symptoms among survivors of surgical NEC or bowel perforation in the neonatal period, in order to identify areas where we can improve or optimize follow-up.
RESEARCH QUESTION
What is the long-term outcome of preterm infants surviving surgical NEC or bowel perforation in the neonatal period?
- Keywords
- necrotizing enterocolitis, bowel perforation, preterm infant, long-term follow-up, quality of life
- Medical subject headings
- Enterocolitis, Necrotizing, Intestinal Perforation, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric quality of life (PedsQL) questionnaire
modular approach measuring health-related QoL in children and adolescents (2-18 years) incl. children with acute and chronic health conditions. This questionnaire comprises of 4 essential core domains namely: Physical Functioning, Emotional Functioning, Social Functioning and School Functioning.
Measured: 2020-2021
Secondary outcomes (6)
Pediatric quality of life (QoL) Gastrointestinal Symptoms
Validated questionnaire assessing gastrointestinal problems.The questionnaire reports data on gastrointestinal symptoms, within 10 scales. The final score goes from 0-100 and higher values indicates less symptoms and better QoL.
Measured: 2025
5-15-R
a standardized questionnaire for parents covering development and behavior of children and adolescents in ages 5 to 17 years
Measured: 2025
Blood samples
Hb, leukocytes with differential count, platelets, reticulocytes, mean corpuscular volume, Hb in reticulocytes, ferritin, 25-OH vitamin D, cobalamine, urea, creatinine, calcium, phosphorous, 9 essential trace elements, a broad panel of other fat and water soluble vitamins.
Data will be reported in SI units, or other conventional measures.
For this outcome we will report data on number of participants with 1, 2, 3 or 4 or more abnormal laboratory values
Measured: 2025
Weight
in kilogram and one decimal (e.g. 24.8 kg)
Measured: 2025
Height
in cm
Measured: 2025
Head circumference
in cm and one decimal (e.g. 45.7 cm)
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trond Flaegstad, MD, PhD, Study director, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757582
- Sponsor's protocol ID
- 2018/1976/REK nord
- Acronym
- NOR-NEC
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2020
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD for this study which is not a RCT
Publications
Hau EM, Meyer SC, Berger S, Goutaki M, Kordasz M, Kessler U. Gastrointestinal sequelae after surgery for necrotising enterocolitis: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F265-F273. doi: 10.1136/archdischild-2017-314435. Epub 2018 Jun 26.
PubMed 29945925Neu J. Necrotizing enterocolitis: the mystery goes on. Neonatology. 2014;106(4):289-95. doi: 10.1159/000365130. Epub 2014 Aug 20.
PubMed 25171544
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up
- ClinicalTrials.gov ID
- NCT06757582
- Acronym / sponsor ID
- NOR-NEC / 2018/1976/REK nord
- Keywords
- necrotizing enterocolitis, bowel perforation, preterm infant, long-term follow-up, quality of life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 3 Jan 2025 (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 syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall. Some preterm infants also develop spontaneous intestinal perforations (SIP) without the classical bowel inflammation/necrosis seen in NEC. NEC and SIP can be challenging to differentiate. Severe cases of both conditions require surgery and often bowel resection, but mortality due to SIP seems lower.
Studies looking at "long-term prognosis" of infants with NEC and bowel perforation have mainly assessed outcome until 2-7 years of age. The primary school years is a vulnerable period for ex-preterm children. Disruption in learning and social integration is of great importance for their quality of life (QoL), but little data exist in this age group. Moreover, nutritional deficits (e.g. cobalamin- or iron-deficiency may impact cognitive development, but this has not been investigated in this "high-risk" population in school age. Authors of a recent systematic review on gastrointestinal sequel after NEC-surgery thus called for "more high-quality studies assessing long-term follow-up".
In this project we will study the long-term impact of surgery for NEC and bowel perforation in preterm infants, both with a quality of life (QoL) perspective and with a focus on development, growth, nutrition and persistent gastrointestinal problems.
Detailed description
INTRODUCTION
Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall. The incidence of NEC is inversely related to birth weight and gestational age (GA), with the majority of affected being very preterm infants (GA < 32 weeks), and in particular extremely preterm infants (GA < 28 weeks). In Scandinavia, the rates of NEC in extremely preterm infants is 6-9% (1-3). NEC is a devastating condition and one of the four main causes of mortality in neonatal intensive care units (NICUs) (4). Some preterm infants also develop spontaneous intestinal perforations (SIP) without the classical bowel inflammation/necrosis seen in NEC. NEC and SIP can be challenging to differentiate. Severe cases of both conditions require surgery and often bowel resection, but mortality due to SIP seems lower (5).
The clinical onset of NEC is usually in the second or third week of life. Typical symptoms and signs are a distended abdomen, periumbilical erythema, bloody stools, feeding intolerance and a generally unstable infant. However, the signs are non-specific, and the diagnosis is usually based on radiographic findings such as intramural bowel gas (6, 17, 18). The severity is classified by modified Bells criteria (18, 19). Stage I refers to suspected, but unconfirmed NEC. Stage II is radiographically confirmed NEC requiring medical therapy including broad-spectrum antibiotics and supportive care. Stage III patients demonstrate clinical signs of bowel necrosis, peritonitis, and septic shock, or radiographic findings of bowel perforation. These patients often receive surgery in addition to intensive care. The mortality rate of NEC is between 20-40%; highest in immature infants and/or stage III disease (20, 21).
Survivors of severe NEC (stage III) require long and often very intensive medical therapy that cause suffering for both patients and their families (18, 20). Moreover, medical therapy of patients with NEC requires huge resources for the neonatal unit and the health care system (20). Those who survive NEC have an increased risk of later gut-associated problems (e.g. short bowel syndrome and strictures) (18, 22), and neurodevelopmental disability (20, 23). Similar results have been observed in follow-up studies after SIP, but less data is available for this condition (23).
Although significant progress has been made in our understanding of NEC/SIP over the last decade, many questions remain regarding the long-term prognosis and optimal follow-up.
Studies looking at "long-term prognosis" of infants with NEC and bowel perforation have mainly assessed outcome until 2-7 years of age (20, 24). The primary school years is a vulnerable period for ex-preterm children. Disruption in learning and social integration is of great importance for their quality of life (QoL), but little data exist in this age group (25). Moreover, nutritional deficits (e.g. cobalamin- or iron-deficiency (26, 27) may impact cognitive development, but this has not been investigated in this "high-risk" population in school age. Authors of a recent systematic review on gastrointestinal sequel after NEC-surgery thus called for "more high-quality studies assessing long-term follow-up" (28).
In this project we will study the long-term impact of surgery for NEC and bowel perforation in preterm infants, both with a quality of life (QoL) perspective and with a focus on development, growth, nutrition and persistent gastrointestinal problems.
AIM
to collect long-term follow-up data on QoL, growth, development, biochemical nutritional status and persistent gastrointestinal symptoms among survivors of surgical NEC or bowel perforation in the neonatal period, in order to identify areas where we can improve or optimize follow-up.
RESEARCH QUESTION
What is the long-term outcome of preterm infants surviving surgical NEC or bowel perforation in the neonatal period?
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Cases and Controls will be identified through the Norwegian Neonatal Network.
Key inclusion criteria (2 listed)
- Case: All Norwegian very preterm infants (gestational age (GA) < 32 weeks) born during the 6-year period 2008-2013, diagnosed with surgical NEC or bowel perforation and surviving up to one year of age will be invited to participate as cases.
- Controls: For each case we will invite two controls matched for important clinical characteristics (e.g. sex, GA, clinical illness score, intracranial pathology, need for oxygen at discharge etc.).
Key exclusion criteria (1 listed)
- not signing informed consent scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pediatric quality of life (PedsQL) questionnaire
Time frame: 2020-2021
modular approach measuring health-related QoL in children and adolescents (2-18 years) incl. children with acute and chronic health conditions. This questionnaire comprises of 4 essential core domains namely: Physical Functioning, Emotional Functioning, Social Functioning and School Functioning.
6 secondary outcomes
Pediatric quality of life (QoL) Gastrointestinal Symptoms
Time frame: 2025
5-15-R
Time frame: 2025
Blood samples
Time frame: 2025
Weight
Time frame: 2025
Height
Time frame: 2025
Head circumference
Time frame: 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Background: PubMed 29945925Hau EM, Meyer SC, Berger S, Goutaki M, Kordasz M, Kessler U. Gastrointestinal sequelae after surgery for necrotising enterocolitis: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F265-F273. doi: 10.1136/archdischild-2017-314435. Epub 2018 Jun 26.
- Results publication: PubMed 25171544Neu J. Necrotizing enterocolitis: the mystery goes on. Neonatology. 2014;106(4):289-95. doi: 10.1159/000365130. Epub 2014 Aug 20.
- Individual participant dataSharing planned: No. no plan to share IPD for this study which is not a RCT
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Early Predictors of Necrotizing Enterocolitis in Neonates
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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.
Trond Flaegstad, MD, PhD study director
University Hospital of North Norway
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 and Intestinal Perforation, run by University Hospital of North Norway at 1 site in Norway.
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 1 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: opening soon, as of the sponsor's last update on 3 Jan 2025. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claus Klingenberg, MD, PhD (91563167 ext. +47, claus.klingenberg@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric quality of life (PedsQL) questionnaire (time frame: 2020-2021). 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 NCT06757582, which also lists 2 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 3 Jan 2025.