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Trial record 14 of 22 for:    Open Studies | "Hernia, Hiatal"
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Open or Keyhole Surgery Through the Chest for Newborn Babies: Effect on Blood Gases (The CO2)

This study is currently recruiting participants.
Verified June 2012 by Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01467245
First received: November 4, 2011
Last updated: June 8, 2012
Last verified: June 2012
History of Changes
  Purpose

This is a pilot randomised controlled trial comparing open versus thoracoscopic surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates. Thoracoscopic surgery involves insufflation of carbon dioxide into the thoracic cavity and may therefore cause hypercapnia and acidosis.


Condition Intervention
Esophageal Atresia With Tracheo-esophageal Fistula
Congenital Diaphragmatic Hernia
 Procedure: Hypercapnia during thoracoscopy
Procedure: Open surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypercapnia During Thoracoscopy or Open Surgery for Repair of Oesophageal Atresia With Tracheo-oesophageal Fistula or Congenital Diaphragmatic Hernia in Neonates: Pilot Randomised Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Great Ormond Street Hospital for Children NHS Foundation Trust:

Primary Outcome Measures:
  • Arterial blood carbon dioxide measurement [ Designated as safety issue: Yes ]
    Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples


Secondary Outcome Measures:
  • oxygenation of the brain [ Designated as safety issue: No ]
    oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy

  • arterial carbon dioxide levels measured transcutaneously [ Designated as safety issue: No ]
    arterial carbon dioxide levels measured transcutaneously by non-invasively using a probe placed on the skin


Estimated Enrollment: 30
Study Start Date: August 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypercapnia during thoracoscopy
keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
 Procedure: Hypercapnia during thoracoscopy
keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
Experimental: Open surgery
open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
 Procedure: Open surgery
open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonates with diagnosis of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia

    ->1.6 Kg

  • Conventional ventilation (no high frequency ventilation or iNO) for at least 24 hours.
  • FiO2 <0.4
  • No requirement for inotropes for at least 24 hours

Exclusion Criteria:

  • Late diagnosis (after 1 month of age)
  • Major congenital heart defects or pulmonary hypertension
  • Bilateral grade IV intraventricular haemorrhage
  • Previous ECMO
  • FiO2 ≥ 0.4
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467245

Contacts
Contact: Agostino Pierro, Prof 0044207 905 2641 a.pierro@ucl.ac.uk
Contact: Mark Bishay 0044207 905 2733 mark.bishay@ucl.ac.uk

Locations
United Kingdom
Great Ormond Street Hospital for Children NHS Trust Recruiting
London, United Kingdom, WC1N 3JH
Contact: Agostino Pierro, Prof     0044207 905 2641     a.pierro@ucl.ac.uk    
Contact: Mark Bishay     0044207 905 2733     mark.bishay@ucl.ac.uk    
Principal Investigator: Agostino Pierro, Prof            
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
Investigators
Principal Investigator: Agostino Pierro, Prof Great Ormond Street Hospital for Children NHS Foundation Trust
  More Information

Publications:

Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01467245     History of Changes
Other Study ID Numbers: 09SG04
Study First Received: November 4, 2011
Last Updated: June 8, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:
Thoracoscopy
congenital diaphragmatic hernia
oesophageal atresia
hypercapnia
 acidosis
cerebral oxygenation
neonates

Additional relevant MeSH terms:
Hernia, Hiatal
Esophageal Atresia
Esophageal Diseases
Esophageal Fistula
Fistula
Hernia
Hernia, Diaphragmatic
Tracheoesophageal Fistula
Digestive System Abnormalities
 Digestive System Diseases
Gastrointestinal Diseases
Congenital Abnormalities
Digestive System Fistula
Pathological Conditions, Anatomical
Respiratory Tract Fistula
Respiratory Tract Diseases
Tracheal Diseases

ClinicalTrials.gov processed this record on May 22, 2013