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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2012 by Great Ormond Street Hospital for Children NHS Foundation Trust.
Recruitment status was Recruiting

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:

Genetics Home Reference related topics: congenital diaphragmatic hernia esophageal atresia/tracheoesophageal fistula

MedlinePlus related topics: Fistulas Hernia

Genetic and Rare Diseases Information Center resources: Congenital Diaphragmatic Hernia Esophageal Atresia Tracheoesophageal Fistula

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

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, see Learn About Clinical Studies.

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:

Yang EY, Allmendinger N, Johnson SM, Chen C, Wilson JM, Fishman SJ. Neonatal thoracoscopic repair of congenital diaphragmatic hernia: selection criteria for successful outcome. J Pediatr Surg. 2005 Sep;40(9):1369-75.

Holcomb GW 3rd, Rothenberg SS, Bax KM, Martinez-Ferro M, Albanese CT, Ostlie DJ, van Der Zee DC, Yeung CK. Thoracoscopic repair of esophageal atresia and tracheoesophageal fistula: a multi-institutional analysis. Ann Surg. 2005 Sep;242(3):422-8; discussion 428-30.

Krosnar S, Baxter A. Thoracoscopic repair of esophageal atresia with tracheoesophageal fistula: anesthetic and intensive care management of a series of eight neonates. Paediatr Anaesth. 2005 Jul;15(7):541-6. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bishay M, Giacomello L, Retrosi G, Thyoka M, Garriboli M, Brierley J, Harding L, Scuplak S, Cross KM, Curry JI, Kiely EM, De Coppi P, Eaton S, Pierro A. Hypercapnia and acidosis during open and thoracoscopic repair of congenital diaphragmatic hernia and esophageal atresia: results of a pilot randomized controlled trial. Ann Surg. 2013 Dec;258(6):895-900. doi: 10.1097/SLA.0b013e31828fab55.


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:


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

ClinicalTrials.gov processed this record on March 01, 2015

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