Risk Factors of Necrotizing Enterocolitis in Premature Newborns

NCT04719546 | Completed

• 1 other identifier: 2020PI279
• Study Type: observational
• Target: 459
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Necrotizing Enterocolitis of Newborn; Risk Factors

Outcome Measures

Primary Outcomes (3)

• Necrotizing enterocolitis (NEC)

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

  10 years

• Risk factor of NEC during Pregnancy

  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)

  10 years

• Gestational age of infants with NEC

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

  10 years

Secondary Outcomes (9)

• Perinatal risk factor of NEC

  10 years

• Place of birth as risk factor for NEC

  10 years

• Asphyxia at birth

  10 years

• NEC occurrence

  10 years

• Gender

  10 years

Study Arms (2)

NEC Group

All Premature Neonates born in Nancy and Lyon over 10 years and presenting with Necrotizing Enterocolitis

Other: Observation of related perinatal factors

Control Group

All Premature Neonates born in Nancy and Lyon over 10 years without Necrotizing Enterocolitis throughout the neonatal period

Other: Observation of related perinatal factors

Interventions

Observation of related perinatal factors OTHER

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

Control Group; NEC Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Premature newborns (\< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria. * Premature newborns (\< 37 weeks of gestation) having grown up without nectrotizing enterocolitis at the same period of time, in order to associate 2 witness patient to one case patient.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (2)

Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, 54035, France

Location

CHU LYON

Bron, 69677, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: January 21, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

FR (2)