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Completed

NCT Number: NCT04719546

Risk Factors of Necrotizing Enterocolitis in Premature Newborns

With premature newborn increase survival, the risk of serious neonatal morbidity, such as necrotizing enterocolitis (NEC), also increased. NEC affects between 2 to 7% of premature infants including 5 to 22% of newborns weighing less than 1000 g.

NEC is an acquired disease, caused by inflammation of the intestinal lining. It is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.

The etiology and physiopathology are multifactorial, complex, and remain poorly understood. The mechanism of the lesions seems to involve factors including immaturity of the intestinal barrier and the immune system, microvascular imbalance, disturbed gut flora and systemic inflammation.

Despite improved knowledge about this disease, the proportion of surviving patients has not improved for several years. It frequently leads to long-term sequelae depending on the severity of the NEC and its treatment.

Early diagnosis and early treatment of NEC may reduce the risk of mortality and morbidity. The aim of this retrospective bi-centric study is to look for risk factors allowing the prediction of NEC in order to prevent and improve the early management of this disease.

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Key information

Conditions

Necrotizing Enterocolitis of Newborn Risk Factors

Sex eligibility

All sexes

Study type

Observational

Primary location

Maternite Regionale Universitaire CHRU NANCY, Nancy, Lorraine, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature newborns (< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria.

Exclusion criteria

  • Children term born (> 37 weeks of gestation)
  • Necrotizing enterocolitis during an hospitalisation outside the NICU of Nancy or Lyon
  • Malformation or pre-existing digestive pathology
  • Complex or severe malformative pathologies

Treatment and study plan

Observation of related perinatal factors

Other

Data described in Primary outcome measures will be collected in both groups

Primary outcomes

  1. Necrotizing enterocolitis (NEC)

    Time frame: 10 years

    Number of infants with NEC at a Bell stage > 1 in Nancy as compared to Lyon

  2. Risk factor of NEC during Pregnancy

    Time frame: 10 years

    Number of infants who had abnormal pregnancy course in each group (defined as the presence of multiple pregnancy; gestational hypertension; Intrauterine Growth Retardation defined as a birth weight below the 10th Centile of Fenton Curves; Abnormal heart rate at the time of delivery)

  3. Gestational age of infants with NEC

    Time frame: 10 years

    Gestational age in weeks of infants presenting with NEC in Nancy as compared to Lyon

Secondary outcomes

  1. Perinatal risk factor of NEC

    Time frame: 10 years

    Number of infants who did not receive antenatal maturation by steroids in Nancy as compared to Lyon

  2. Place of birth as risk factor for NEC

    Time frame: 10 years

    Number of outborn infants in Nancy as compared to Lyon

  3. Asphyxia at birth

    Time frame: 10 years

    Number of infants with an APGAR score < 7 in Nancy as compared to Lyon

  4. NEC occurrence

    Time frame: 10 years

    Age of NEC onset in Nancy as compared to Lyon

  5. Gender

    Time frame: 10 years

    Rate of baby boys presenting NEC in Nancy as compared to Lyon

  6. Patent Ductus Arteriosus (PDA)

    Time frame: 10 years

    Number of enfants presenting a PDA requiring treatment in Nancy as compared to Lyon

  7. Feeding

    Time frame: 10 years

    Number of infants for each Type of milk at the point of date in Nancy as compared to Lyon (Mothers own milk versus milk bank versus formula )

  8. Infection

    Time frame: 10 years

    Number of infants treated for infection in Nancy as compared to Lyon

  9. Red Blood Cell transfusion

    Time frame: 10 years

    Number of infants who required a transfusion before the occurence of NEC in Nancy as compared to Lyon

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Identifying Risk Factors of Necrotizing Enterocolitis in the NICU of Nancy Benchmarking With the NICU of Lyon Over 10 Years

Acronym: ECUNancyLyon

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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