Status:
COMPLETED
Open or Keyhole Surgery Through the Chest for Newborn Babies: Effect on Blood Gases
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Conditions:
Esophageal Atresia With Tracheo-esophageal Fistula
Congenital Diaphragmatic Hernia
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief 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 neonate...
Eligibility Criteria
Inclusion
- 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
- Late diagnosis (after 1 month of age)
- Major congenital heart defects or pulmonary hypertension
- Bilateral grade IV intraventricular haemorrhage
- Previous ECMO
- FiO2 ≥ 0.4
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01467245
Start Date
August 1 2009
End Date
August 1 2013
Last Update
March 2 2022
Active Locations (1)
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1
Great Ormond Street Hospital for Children NHS Trust
London, United Kingdom, WC1N 3JH