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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Esophageal Atresia With Tracheo-esophageal Fistula, Congenital Diaphragmatic Hernia

Intervention / Treatment
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* Procedure: Hypercapnia during thoracoscopy
* Procedure: Open surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypercapnia during thoracoscopy<br>keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates | Procedure: Hypercapnia during thoracoscopy<br>* keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates<br>|
| Experimental: Open surgery<br>open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates | Procedure: Open surgery<br>* open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood carbon dioxide measurement | Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygenation of the brain | oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy | Intra-operative and 24 hours post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracoscopy, congenital diaphragmatic hernia, oesophageal atresia, hypercapnia, acidosis, cerebral oxygenation, neonates