BridgeMD
New treatment option for Tracheo-Esophageal Fistula with Atresia of Esophagus
Official title Use of Indocyanine Green During Primary Repair of Oesophageal Atresia and Distal Tracheo-oesophageal Fistula
ClinicalTrials.gov ID: NCT05735964
What this study is testing
What is Indocyanine green?
Indocyanine green is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for tracheo-esophageal fistula with atresia of esophagus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to look at babies having a primary or delayed primary oesophageal repair for OA with dTOF to evaluate if using Indocyanine green (ICG) and near infrared fluorescence (NIRF) can decrease the rates of anastomotic leaks and/or predict which patients they will happen in. The latter evaluation would help counsel parents and mean that further research can evaluate if other tactics can prevent the leak being a moderate or severe problem.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 1
You may be able to join if
- Pre-operative
- Diagnosis of oesophageal atresia with distal trachea-oesophageal fistula (OA/dTOF)
- Plan for primary or delayed primary oesophageal anastomosis Intra-operative
- Diagnosis of OA/dTOF confirmed by standard methods
- Primary or delayed primary oesophageal anastomosis considered clinically, physiologically, and technically feasible
You likely can't join if
- Pre-operative
- Under 2.5kg in weight
- Complex cardiac disease
- Allergic to ICG
- Allergic to iodine or iodides
- Hyperthyroidism
See the full eligibility criteria
- Pre-operative
- Diagnosis of oesophageal atresia with distal trachea-oesophageal fistula (OA/dTOF)
- Plan for primary or delayed primary oesophageal anastomosis Intra-operative
- Diagnosis of OA/dTOF confirmed by standard methods
- Primary or delayed primary oesophageal anastomosis considered clinically, physiologically, and technically feasible
- Pre-operative
- Under 2.5kg in weight
- Complex cardiac disease
- Allergic to ICG
- Allergic to iodine or iodides
- Hyperthyroidism
- Chronic Kidney Disease stage V
- Unwilling to participate
- Those in whom exchange transfusion is indicated due to hyperbilirubinemia Intra-operative
- Anaesthetic concerns contra-indicating the use of intravenous ICG due its temporary effect on oxygen saturation readings prior to injection of ICG
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 1 year. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.