Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis

NARecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

February 22, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

September 30, 2025

Conditions
Preterm BirthEnterocolitis, Necrotizing
Interventions
PROCEDURE

laparotomy

Exploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion

PROCEDURE

Laparoscopy

laparoscopy with insufflation of CO2 (placement of a 3mm trocar in the left hypochondrium and insufflation of a pneumoperitoneum (carbon dioxide, pressure: 6 mmHg, flow rate: 1.5 Liter/minute) for a duration of at least 5 minutes.

Trial Locations (2)

75012

RECRUITING

Hôpital Armand Trousseau Service de Chirurgie Pédiatrique et Néonatale, Paris

Unknown

RECRUITING

Hôpital Robert Debré Service de Chirurgie Pédiatrique, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER