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OpenTrials
Completed

NCT Number: NCT01467245

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

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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Key information

Conditions

Esophageal Atresia With Tracheo-esophageal Fistula Acid-Base Imbalance Acidosis Congenital Abnormalities Congenital Diaphragmatic Hernia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Esophageal Atresia Esophageal Diseases Esophageal atresia with or without tracheoesophageal fistula Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Hypercapnia Internal Hernia Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Great Ormond Street Hospital for Children NHS Trust

London, WC1N 3JH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypercapnia during thoracoscopy

Procedure

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

Open Surgery

Procedure

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

Primary outcomes

  1. Arterial blood carbon dioxide measurement

    Time frame: Intra-operative

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

Secondary outcomes

  1. oxygenation of the brain

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

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

Sponsors and collaborators

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Other

Registry information

Official study 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

Acronym: CO2

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Nov 8, 2011
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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