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

Great Ormond Street Hospital for Children NHS Foundation Trust20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Atresia With Tracheo-esophageal Fistula Congenital Diaphragmatic Hernia

Interventions

Hypercapnia during thoracoscopyPROCEDURE

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

Open surgeryPROCEDURE

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

Eligibility

Sex: ALLMax age: 1 Month

Medical Language ↔ Plain English

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

Locations (1)

Great Ormond Street Hospital for Children NHS Trust

London, United Kingdom

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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