NCT05129930

Brief Summary

Esophageal atresia is a rare but severe malformation, and it requires early surgery. Coloesophagoplasty is surgical repair of the esophageal with an isoperistaltic transverse colon graft. In the postoperative period after coloesophagoplasty children require careful monitoring of fluid balance, because clinically significant fluid overload can lead to dysfunction of various organs and systems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

December 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
Last Updated

November 22, 2021

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

October 7, 2021

Last Update Submit

November 11, 2021

Conditions

Water-Electrolyte ImbalanceIntensive Care UnitsPediatricCritical IllnessLength of StayRespiratory FailureEsophageal Atresia

Keywords

LiquidLiquid overloadMechanical ventilationInfantPreschool ChildRespiratory failureColoesophagoplastyEsophageal atresia

Outcome Measures

Primary Outcomes (25)

  • duration of intensive care unit (ICU) stay

    number of days in ICU after surgery before discharge

    up to 30 days after the surgery

  • duration of mechanical ventilation (MV)

    number of days of MV after surgery before switching to continuous positive airway pressure (CPAP)

    up to 30 days after the surgery

  • intraoperative fluid overload (IVF)

    ((injected fluid (ml) - diuresis (ml) - blood loss (ml))/weight before surgery)\*100%

    during the surgery

  • fluid overload (FO) on the first postoperative day in the ICU

    ((injected fluid (ml)-lost fluid (ml))/weight before admission to ICU)\*100%

    during the first postoperative day, exclude intraoperative period

  • total fluid overload on the first postoperative day

    ((injected fluid (ml) - lost fluid (ml))/weight before surgery)\*100%

    during the first postoperative day, include intraoperative period

  • Fraction of Inspired Oxygen (FiO2)

    Fraction of Inspired Oxygen (FiO2)

    in the the first postoperative day

  • Fraction of Inspired Oxygen (FiO2)

    Fraction of Inspired Oxygen (FiO2)

    in the second postoperative day

  • Fraction of Inspired Oxygen (FiO2)

    Fraction of Inspired Oxygen (FiO2)

    in the third postoperative day

  • Oxygen saturation (Sp02)

    Oxygen saturation (Sp02)

    in the first postoperative day

  • Oxygen saturation (Sp02)

    Oxygen saturation (Sp02)

    in the second postoperative day

  • Oxygen saturation (Sp02)

    Oxygen saturation (Sp02)

    in the third postoperative day

  • Venous oxygen saturation (Svo2)

    Venous oxygen saturation (Svo2)

    in the first postoperative day

  • Venous oxygen saturation (Svo2)

    Venous oxygen saturation (Svo2)

    in the second postoperative day

  • Venous oxygen saturation (Svo2)

    Venous oxygen saturation (Svo2)

    in the third postoperative day

  • partial pressure of carbon dioxide (pC02)

    partial pressure of carbon dioxide (pC02)

    in the first postoperative day

  • partial pressure of carbon dioxide (pC02)

    partial pressure of carbon dioxide (pC02)

    in the second postoperative day

  • partial pressure of carbon dioxide (pC02)

    partial pressure of carbon dioxide (pC02)

    in the third postoperative day

  • inspiratory pressure (Pin)

    inspiratory pressure (Pin)

    in the first postoperative day

  • inspiratory pressure (Pin)

    inspiratory pressure (Pin)

    in the second postoperative day

  • inspiratory pressure (Pin)

    inspiratory pressure (Pin)

    in the third postoperative day

  • Positive end-expiratory pressure (PEEP)

    Positive end-expiratory pressure (PEEP)

    in the first postoperative day

  • Positive end-expiratory pressure (PEEP)

    Positive end-expiratory pressure (PEEP)

    in the second postoperative day

  • Positive end-expiratory pressure (PEEP)

    Positive end-expiratory pressure (PEEP)

    in the third postoperative day

  • duration of ICU stay corrected to sedation

    duration of ICU stay corrected for the duration of sedation

    up to 30 days after the surgery

  • duration of MV corrected to sedation

    duration of MV corrected for the duration of sedation

    up to 30 days after the surgery

Eligibility Criteria

Age1 Month - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

40 children with EA with/without TPF, aged from 1 month to 3 years, who underwent coloesophagoplasty at the N.F. Filatov Children city Hospital, Moscow, Russia, from December 1, 2017 to December 31, 2020.

You may qualify if:

  • Аge from 1 month to 3 years
  • EA with / without
  • Tracheoesophageal fistula (TPF)
  • Сoloesophagoplasty.

You may not qualify if:

  • Аesophageal burn,
  • Oesophageal peptic stenosis,
  • Congenital heart disease
  • Cardiotonic support in the postoperative period
  • Renal malformations
  • Bacterial pneumonia in the postoperative period,
  • Bronchopulmonary malformations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

N.F. Filatov Childrens city hospital

Moscow, Russia

Location

MeSH Terms

Conditions

Water-Electrolyte ImbalanceCritical IllnessRespiratory InsufficiencyEsophageal Atresia

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesDigestive System AbnormalitiesDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Sergey M Stepanenko, PhD, Prof.

    Pirogov Russian National Research Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2021

First Posted

November 22, 2021

Study Start

December 1, 2020

Primary Completion

February 20, 2021

Study Completion

May 1, 2021

Last Updated

November 22, 2021

Record last verified: 2020-12

Locations

RU(1)