NCT03142685

Brief Summary

To evaluate the feasibility of performing a randomized pilot control trial of two diagnostic screening strategies for necrotizing enterocolitis in patients with congenital heart disease. Measures to evaluate will be the ability to obtain consent from patients, percentage of eligible patients that are able to be recruited, coordination of providers, estimation of degree of crossover and ability to perform the screening exams per protocol.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

April 26, 2017

Last Update Submit

July 16, 2018

Conditions

Enterocolitis, NecrotizingCongenital Heart Disease

Keywords

NECBowel UltrasoundCHD

Outcome Measures

Primary Outcomes (1)

  • Days NPO due to NEC concern

    The number of days that a patient has no enteral feedings due to concern for necrotizing enterocolitis.

    From the date of enrollment to the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 500 days.

Secondary Outcomes (2)

  • ICU length of stay

    From the date of enrollment to the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 500 days.

  • Hospital length of stay

    From the date of enrollment to the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 500 days.

Study Arms (2)

Arm B: Kub + Bowel US

EXPERIMENTAL

Subjects clinical suspected of NEC whom are randomized into Arm B at time of consent will receive a bowel ultrasound q24 for 48 hours and a KUB q12 for 48 hours.

Device: Bowel Ultrasound

Arm A: KUB Only

NO INTERVENTION

Subjects clinical suspected of NEC whom are randomized into Arm A at time of consent will receive a KUB q12 for 48 hours. This is the current standard-of-care procedures.

Interventions

Bowel UltrasoundDEVICE

Subjects randomized to Arm B will undergo a bowel ultrasound q24 for 48 hours after time of clinical suspicion of NEC. This is in addition to the standard of care KUBs which patients in both arms will get.

Arm B: Kub + Bowel US

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients age 0-6 months with CHD
  • Completed one or more cardiac surgeries for CHD
  • Clinicians are suspicious for NEC and order an abdominal radiograph for screening.

You may not qualify if:

  • Patients with isolated PDA or PFO congenital cardiac abnormalities
  • Unable to ultrasound the bowel (eg. gut in silo)
  • Prior heart transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (12)

  • M. Epelman, A. Daneman, D. Podeberesky, L. Averill, K. Darge, paper presented at the Radiological Society of North America, Chicago, 2015.

    BACKGROUND

  • Epelman M, Daneman A, Navarro OM, Morag I, Moore AM, Kim JH, Faingold R, Taylor G, Gerstle JT. Necrotizing enterocolitis: review of state-of-the-art imaging findings with pathologic correlation. Radiographics. 2007 Mar-Apr;27(2):285-305. doi: 10.1148/rg.272055098.

    PMID: 17374854RESULT

  • Staryszak J, Stopa J, Kucharska-Miasik I, Osuchowska M, Guz W, Blaz W. Usefulness of ultrasound examinations in the diagnostics of necrotizing enterocolitis. Pol J Radiol. 2015 Jan 1;80:1-9. doi: 10.12659/PJR.890539. eCollection 2015.

    PMID: 25574248RESULT

  • Pickard SS, Feinstein JA, Popat RA, Huang L, Dutta S. Short- and long-term outcomes of necrotizing enterocolitis in infants with congenital heart disease. Pediatrics. 2009 May;123(5):e901-6. doi: 10.1542/peds.2008-3216.

    PMID: 19403484RESULT

  • McElhinney DB, Hedrick HL, Bush DM, Pereira GR, Stafford PW, Gaynor JW, Spray TL, Wernovsky G. Necrotizing enterocolitis in neonates with congenital heart disease: risk factors and outcomes. Pediatrics. 2000 Nov;106(5):1080-7. doi: 10.1542/peds.106.5.1080.

    PMID: 11061778RESULT

  • Motta C, Scott W, Mahony L, Koch J, Wyckoff M, Reisch J, Burchfield PJ, Brion LP. The association of congenital heart disease with necrotizing enterocolitis in preterm infants: a birth cohort study. J Perinatol. 2015 Nov;35(11):949-53. doi: 10.1038/jp.2015.96. Epub 2015 Aug 6.

    PMID: 26248130RESULT

  • Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.

    PMID: 12084585RESULT

  • Becker KC, Hornik CP, Cotten CM, Clark RH, Hill KD, Smith PB, Lenfestey RW. Necrotizing enterocolitis in infants with ductal-dependent congenital heart disease. Am J Perinatol. 2015 Jun;32(7):633-8. doi: 10.1055/s-0034-1390349. Epub 2014 Dec 8.

    PMID: 25486286RESULT

  • Walsh MC, Kliegman RM. Necrotizing enterocolitis: treatment based on staging criteria. Pediatr Clin North Am. 1986 Feb;33(1):179-201. doi: 10.1016/s0031-3955(16)34975-6.

    PMID: 3081865RESULT

  • Kim WY, Kim WS, Kim IO, Kwon TH, Chang W, Lee EK. Sonographic evaluation of neonates with early-stage necrotizing enterocolitis. Pediatr Radiol. 2005 Nov;35(11):1056-61. doi: 10.1007/s00247-005-1533-4. Epub 2005 Aug 3.

    PMID: 16078076RESULT

  • Coursey CA, Hollingsworth CL, Gaca AM, Maxfield C, Delong D, Bisset G 3rd. Radiologists' agreement when using a 10-point scale to report abdominal radiographic findings of necrotizing enterocolitis in neonates and infants. AJR Am J Roentgenol. 2008 Jul;191(1):190-7. doi: 10.2214/ajr.07.3558.

    PMID: 18562745RESULT

  • Faingold R, Daneman A, Tomlinson G, Babyn PS, Manson DE, Mohanta A, Moore AM, Hellmann J, Smith C, Gerstle T, Kim JH. Necrotizing enterocolitis: assessment of bowel viability with color doppler US. Radiology. 2005 May;235(2):587-94. doi: 10.1148/radiol.2352031718.

    PMID: 15858098RESULT

MeSH Terms

Conditions

Enterocolitis, NecrotizingHeart Defects, Congenital

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Sherwin S Chan, MD PhD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: This is a prospective pilot randomized control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Radiologist

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 5, 2017

Study Start

January 1, 2017

Primary Completion

December 31, 2017

Study Completion

June 30, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)