NCT02525705

Brief Summary

The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping syndrome in children operated at birth for oesophageal atresia type III et IV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

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

June 14, 2011

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

6.6 years

First QC Date

August 14, 2015

Last Update Submit

August 1, 2019

Conditions

Oesophageal AtresiaDumping Syndrome

Keywords

infantsoesophageal atresiadumping syndromeprevalenceType III and IVOral glucose tolerance testearly hyperglycemialate hypoglycemia

Outcome Measures

Primary Outcomes (2)

  • Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)

    Hypoglycemia : glycemia \< 0,6 g/L

    up to 240 min

  • Late hypoglycemia during OGTT

    Hyperglycemia : \> 1,8g/L from H0 to 30 min after oral intake, \> 1.7 between 1 and 2 h ours, \> 1.4 between 2 and 3 h , \> 1, 26 after 3 h

    up to 240 min

Secondary Outcomes (4)

  • Clinical signs presenting consequently to OGTT

    continuous monitoring during 240 minutes

  • Associated pathologies

    1 day

  • Surgery details

    1 day

  • Post-surgery complications

    1 day

Study Arms (1)

Every EA patients

EXPERIMENTAL

This is a one group interventional study. Every patient is included in the same arm.

Biological: Oral Glucose

Interventions

Oral GlucoseBIOLOGICAL

1.75g/kg of glucose is orally taken by the patient. Capillary glycemia is systematically realised before ingestion (H0) and after 30, 60, 90, 120, 180 and 240 min and/or if clinical signs of hypoglycemia are presented by the patient.

Every EA patients

Eligibility Criteria

AgeUp to 14 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • New born less than 3.5 months or age corrected for premature new born
  • Weight ≥ 4, 150 kg
  • Esophageal atresia (EA) type III or IV
  • EA Surgery between May 2013 and June 2016
  • Stop of prokinetic treatment \> 72 h before OGTT
  • Information and consent of parents
  • Patients with health insurance

You may not qualify if:

  • Age \> 3.5 months
  • Weight \< 4.150 kg
  • Other types of EA
  • Dumping syndrom from other origin: microgastria, dysautonomia, small intestine surgery
  • Other pathology that can modify glycemia: neonatal diabete, hyperinsulinism
  • Treatment that can modify gastric motility: domperidone, erythromycin, baclofen that hasn't been stopped in the 72h before OGTT
  • Absence of consent
  • Patient judiciary protected
  • Simultaneous participation to another clinical trial
  • No health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hôpital Pellegrin - Hôpital d'Enfants,

Bordeaux, France

Location

CHU Grenoble

Grenoble, France

Location

Hôpital Jeanne de Flandre CHRU

Lille, France

Location

Hôpital Edouard Herriot,Unité d'Hépatogastroentérologie et Nutrition Pédiatriques

Lyon, France

Location

CHU Nantes

Nantes, France

Location

AP-HP, Hôpital Necker

Paris, France

Location

Hôpital Robert Debré ,Service de chirurgie viscérale et urologique

Paris, France

Location

CHU Rouen

Rouen, France

Location

CHU Strasbourg

Strasbourg, France

Location

CHU Toulouse, Hôpital Enfant

Toulouse, France

Location

Related Publications (7)

  • Bufler P, Ehringhaus C, Koletzko S. Dumping syndrome: a common problem following Nissen fundoplication in young children. Pediatr Surg Int. 2001 Jul;17(5-6):351-5. doi: 10.1007/s003830000525.

    PMID: 11527163RESULT

  • Samuk I, Afriat R, Horne T, Bistritzer T, Barr J, Vinograd I. Dumping syndrome following Nissen fundoplication, diagnosis, and treatment. J Pediatr Gastroenterol Nutr. 1996 Oct;23(3):235-40. doi: 10.1097/00005176-199610000-00006.

    PMID: 8890072RESULT

  • Zung A, Zadik Z. Acarbose treatment of infant dumping syndrome: extensive study of glucose dynamics and long-term follow-up. J Pediatr Endocrinol Metab. 2003 Jul-Aug;16(6):907-15. doi: 10.1515/jpem.2003.16.6.907.

    PMID: 12948306RESULT

  • Ng DD, Ferry RJ Jr, Kelly A, Weinzimer SA, Stanley CA, Katz LE. Acarbose treatment of postprandial hypoglycemia in children after Nissen fundoplication. J Pediatr. 2001 Dec;139(6):877-9. doi: 10.1067/mpd.2001.119169.

    PMID: 11743518RESULT

  • Michaud L, Sfeir R, Couttenier F, Turck D, Gottrand F. Dumping syndrome after esophageal atresia repair without antireflux surgery. J Pediatr Surg. 2010 Apr;45(4):E13-5. doi: 10.1016/j.jpedsurg.2010.01.016.

    PMID: 20385264RESULT

  • Holschneider P, Dubbers M, Engelskirchen R, Trompelt J, Holschneider AM. Results of the operative treatment of gastroesophageal reflux in childhood with particular focus on patients with esophageal atresia. Eur J Pediatr Surg. 2007 Jun;17(3):163-75. doi: 10.1055/s-2007-965087.

    PMID: 17638154RESULT

  • Aumar M, Gottrand F, Chalouhi C, Blanc S, Thomassin N, Piloquet H, Gastineau S, Schneider A, Krishnan U, Duvoisin G, Turck D, Coopman S, Michaud L. Frequency of Abnormal Glucose Tolerance Test Suggestive of Dumping Syndrome Following Oesophageal Atresia Repair. J Pediatr Gastroenterol Nutr. 2020 Jun;70(6):820-824. doi: 10.1097/MPG.0000000000002651.

    PMID: 32443041DERIVED

MeSH Terms

Conditions

Esophageal AtresiaDumping SyndromeHyperglycemia

Interventions

Glucose

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPostgastrectomy SyndromesStomach DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Laurent Michaud, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 17, 2015

Study Start

June 14, 2011

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)