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CompletedNCT01467245CO2Updated Mar 2, 2022

Open or Keyhole Surgery Through the Chest for Newborn Babies: Effect on Blood Gases

An interventional study of Hypercapnia during thoracoscopy and Open surgery in Esophageal Atresia With Tracheo-esophageal Fistula and Congenital Diaphragmatic Hernia, sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged Up to 1 Month. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Aug 2009, registered Nov 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
Up to 1 Month
Sex
All
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Study 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.

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Conditions studied

  • Esophageal Atresia With Tracheo-esophageal Fistula
  • Congenital Diaphragmatic Hernia

Keywords

  • Thoracoscopy
  • congenital diaphragmatic hernia
  • oesophageal atresia
  • hypercapnia
  • acidosis
  • cerebral oxygenation
  • neonates
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In context

Hernias, Diaphragmatic, Congenital

95 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.

This study's enrollment of 20 is below the median of 29 across 66 interventional studies indexed under Hernias, Diaphragmatic, Congenital.

Browse Hernias, Diaphragmatic, Congenital studies →

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust is the lead sponsor of 82 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 1 Month
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

  • Experimental
    Open surgery

    open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates

    Procedure: Open surgery

Interventions

  • ProcedureHypercapnia during thoracoscopy

    keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates

  • ProcedureOpen surgery

    open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates

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What researchers measure

Primary outcomes

  1. Arterial blood carbon dioxide measurement

    Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples

    Time frame: Intra-operative

Secondary outcomes

  1. oxygenation of the brain

    oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy

    Time frame: Intra-operative and 24 hours post-operatively

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Study locations

1 site
  • Great Ormond Street Hospital for Children NHS Trust
    London, WC1N 3JH, United Kingdom
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References and documents

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. doi: 10.1016/j.jpedsurg.2005.05.036. PubMed 16150335 ↗
  • 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. doi: 10.1097/01.sla.0000179649.15576.db. PubMed 16135928 ↗
  • 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. doi: 10.1111/j.1460-9592.2005.01594.x. PubMed 15960636 ↗
  • 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. PubMed 23604057 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01467245
Lead sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Responsible party
Sponsor
First posted
Nov 8, 2011
Start date
Aug 2009
Primary completion
Feb 2011
Completion
Aug 2013
Last update
Mar 2, 2022

Study contacts

Agostino Pierro, Prof
principal investigator · Great Ormond Street Hospital for Children NHS Foundation Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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