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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophageal Atresia With Tracheo-esophageal Fistula Congenital Diaphragmatic Hernia | Procedure: Hypercapnia during thoracoscopy Procedure: Open surgery | Not Applicable |
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 |

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
|
- Arterial blood carbon dioxide measurementArterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples
- oxygenation of the brainoxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy
- arterial carbon dioxide levels measured transcutaneouslyarterial carbon dioxide levels measured transcutaneously by non-invasively using a probe placed on the skin

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 |
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

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
Contact: Agostino Pierro, Prof | 0044207 905 2641 | a.pierro@ucl.ac.uk | |
Contact: Mark Bishay | 0044207 905 2733 | mark.bishay@ucl.ac.uk |
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 |
Principal Investigator: | Agostino Pierro, Prof | Great Ormond Street Hospital for Children NHS Foundation Trust |
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 |