Journal article
Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Multicenter Randomized Clinical Trial
Annals of surgery, Vol.274(4), pp.e370-e380
10/01/2021
DOI: 10.1097/SLA.0000000000005099
PMCID: PMC8439547
PMID: 34506326
Abstract
The aim of this study was to determine which initial surgical treatment results in the lowest rate of death or neurodevelopmental impairment (NDI) in premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP).
The impact of initial laparotomy versus peritoneal drainage for NEC or IP on the rate of death or NDI in extremely low birth weight infants is unknown.
We conducted the largest feasible randomized trial in 20 US centers, comparing initial laparotomy versus peritoneal drainage. The primary outcome was a composite of death or NDI at 18 to 22 months corrected age, analyzed using prespecified frequentist and Bayesian approaches.
Of 992 eligible infants, 310 were randomized and 96% had primary outcome assessed. Death or NDI occurred in 69% of infants in the laparotomy group versus 70% with drainage [adjusted relative risk (aRR) 1.0; 95% confidence interval (CI): 0.87-1.14]. A preplanned analysis identified an interaction between preoperative diagnosis and treatment group (P = 0.03). With a preoperative diagnosis of NEC, death or NDI occurred in 69% after laparotomy versus 85% with drainage (aRR 0.81; 95% CI: 0.64-1.04). The Bayesian posterior probability that laparotomy was beneficial (risk difference <0) for a preoperative diagnosis of NEC was 97%. For preoperative diagnosis of IP, death or NDI occurred in 69% after laparotomy versus 63% with drainage (aRR, 1.11; 95% CI: 0.95-1.31); Bayesian probability of benefit with laparotomy = 18%.
There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage. However, the preoperative diagnosis of NEC or IP modified the impact of initial treatment.
Details
- Title: Subtitle
- Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Multicenter Randomized Clinical Trial
- Creators
- Martin L Blakely - Vanderbilt University Medical CenterJon E Tyson - The University of Texas Health Science Center at HoustonKevin P Lally - The University of Texas Health Science Center at HoustonSusan R Hintz - Stanford UniversityBarry Eggleston - Research Triangle Park FoundationDavid K Stevenson - Stanford UniversityGail E Besner - The Ohio State UniversityAbhik Das - RTI InternationalRobin K Ohls - University of New MexicoWilliam E Truog - Children's Mercy HospitalLeif D Nelin - The Ohio State UniversityBrenda B Poindexter - Cincinnati Children's Hospital Medical CenterClaudia Pedroza - The University of Texas Health Science Center at HoustonMichele C Walsh - Case Western Reserve UniversityBarbara J Stoll - The University of Texas Health Science Center at HoustonRachel Geller - University of California, Los AngelesKathleen A Kennedy - The University of Texas Health Science Center at HoustonReed A Dimmitt - University of Alabama at BirminghamWaldemar A Carlo - University of Alabama at BirminghamC Michael Cotten - Duke UniversityAbbot R Laptook - Brown UniversityKrisa P Van Meurs - Stanford UniversityKara L Calkins - University of California, Los AngelesGregory M Sokol - Indiana UniversityPablo J Sanchez - The Ohio State UniversityMyra H Wyckoff - The University of Texas Southwestern Medical CenterRavi M Patel - Emory UniversityIvan D Frantz III - Beth Israel Deaconess Medical CenterSeetha Shankaran - Wayne State UniversityCarl T D'Angio - University of RochesterBradley A Yoder - University of UtahEdward F Bell - University of IowaKristi L Watterberg - University of New MexicoColin A Martin - University of Alabama at BirminghamCarroll M Harmon - University of Alabama at BirminghamHenry Rice - Duke UniversityArlet G Kurkchubasche - Brown UniversityKarl Sylvester - Stanford UniversityJames C Y Dunn - Stanford UniversityTroy A Markel - Indiana UniversityDiana L Diesen - The University of Texas Southwestern Medical CenterAmina M Bhatia - Emory UniversityAlan Flake - University of PennsylvaniaWalter J Chwals - Tufts Medical CenterRebeccah Brown - Cincinnati Children's Hospital Medical CenterKathryn D Bass - Women & Children's Hospital of BuffaloShawn D St Peter - Children's Mercy HospitalChristina M Shanti - Indiana UniversityWalter Pegoli Jr - University of RochesterDavid Skarda - University of UtahJoel Shilyansky - University of IowaDavid G Lemon - University of New MexicoRicardo A Mosquera - The University of Texas Health Science Center at HoustonMyriam Peralta-Carcelen - University of Alabama at BirminghamRicki F Goldstein - Duke UniversityBetty R Vohr - Brown UniversityIsabell B Purdy - University of California, Los AngelesAbbey C Hines - Indiana UniversityNathalie L Maitre - The Ohio State UniversityRoy J Heyne - The University of Texas Southwestern Medical CenterSara B DeMauro - University of PennsylvaniaElisabeth C McGowan - Brown UniversityKimberly Yolton - Cincinnati Children's Hospital Medical CenterHoward W Kilbride - Children's Mercy HospitalGirija Natarajan - Wayne State UniversityKelley Yost - University of RochesterSarah Winter - University of UtahTarah T Colaizy - University of IowaMatthew M Laughon - University of North Carolina at Chapel HillSatyanarayana Lakshminrusimha - University of RochesterRosemary D Higgins - National Institutes of HealthEunice Kennedy Shriver National Institute of Child Health, Human Development Neonatal Research Network
- Resource Type
- Journal article
- Publication Details
- Annals of surgery, Vol.274(4), pp.e370-e380
- DOI
- 10.1097/SLA.0000000000005099
- PMID
- 34506326
- PMCID
- PMC8439547
- NLM abbreviation
- Ann Surg
- ISSN
- 1528-1140
- eISSN
- 1528-1140
- Grant note
- UG1 HD068244 / NICHD NIH HHS UL1 TR000142 / NCATS NIH HHS U10 HD053124 / NICHD NIH HHS UL1 TR003142 / NCATS NIH HHS UG1 HD027851 / NICHD NIH HHS UG1 HD053089 / NICHD NIH HHS UG1 HD040492 / NICHD NIH HHS UL1 TR000006 / NCATS NIH HHS UG1 HD027904 / NICHD NIH HHS U24 HD095254 / NICHD NIH HHS UL1 TR000041 / NCATS NIH HHS UG1 HD068284 / NICHD NIH HHS U10 HD053119 / NICHD NIH HHS U10 HD027871 / NICHD NIH HHS UL1 RR025764 / NCRR NIH HHS UG1 HD027880 / NICHD NIH HHS UG1 HD053109 / NICHD NIH HHS U10 HD021373 / NICHD NIH HHS U10 HD036790 / NICHD NIH HHS UL1 TR003167 / NCATS NIH HHS UL1 TR001863 / NCATS NIH HHS UG1 HD068263 / NICHD NIH HHS UG1 HD021385 / NICHD NIH HHS UG1 HD087226 / NICHD NIH HHS UL1 TR000454 / NCATS NIH HHS UL1 TR000077 / NCATS NIH HHS UG1 HD068270 / NICHD NIH HHS UG1 HD087229 / NICHD NIH HHS UL1 TR000042 / NCATS NIH HHS UG1 HD040689 / NICHD NIH HHS U01 HD036790 / NICHD NIH HHS UL1 TR001117 / NCATS NIH HHS UG1 HD034216 / NICHD NIH HHS UL1 TR000093 / NCATS NIH HHS UG1 HD027856 / NICHD NIH HHS UG1 HD021364 / NICHD NIH HHS UG1 HD027853 / NICHD NIH HHS UG1 HD068278 / NICHD NIH HHS
- Language
- English
- Date published
- 10/01/2021
- Academic Unit
- Stead Family Department of Pediatrics; Surgery; Neonatology
- Record Identifier
- 9984322800802771
Metrics
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