We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Open or Keyhole Surgery Through the Chest for Newborn Babies: Effect on Blood Gases (The CO2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01467245
Recruitment Status : Unknown
Verified June 2012 by Great Ormond Street Hospital for Children NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : November 8, 2011
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Esophageal Atresia With Tracheo-esophageal Fistula Congenital Diaphragmatic Hernia Procedure: Hypercapnia during thoracoscopy Procedure: Open surgery

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : August 2009
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Arterial blood carbon dioxide measurement
    Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples


Secondary Outcome Measures :
  1. oxygenation of the brain
    oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy

  2. arterial carbon dioxide levels measured transcutaneously
    arterial carbon dioxide levels measured transcutaneously by non-invasively using a probe placed on the skin


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01467245     History of Changes
Other Study ID Numbers: 09SG04
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012

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
Fistula
Hernia, Diaphragmatic
Hernias, Diaphragmatic, Congenital
Esophageal Atresia
Esophageal Fistula
Tracheoesophageal Fistula
Pathological Conditions, Anatomical
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Fistula
Respiratory Tract Fistula
Respiratory Tract Diseases
Tracheal Diseases