RecruitingACTRN12607000072415

Endocrine function following Heart Surgery in Infants less than 3 months of age.

Thyroid hormone levels and cortisol levels post congenital heart surgery in infants less than 3 months of age. Delineation of acceptable range and investigation of association with outcome.


Sponsor

Principle Investigator - Kevin Plumpton

Enrollment

50 participants

Start Date

Jul 10, 2006

Study Type

Observational

Conditions

Summary

This observational study aims to further the understanding of how the endocrine system recovers following congenital heart surgery. Infants less than 3 months of age have more deaths and complications following congenital heart surgery than older children and adults. They have immature organ systems and may not be able to respond as rapidly as older children to the critical illness that congenital heart surgery causes. The study requires extra blood samples to be taken in addition to the routine blood tests that are taken during the recovery period in the paediatric intensive care unit. These blood samples will be obtained from indwelling lines that the patients will have in place. The test results will be analysed to delineate what an acceptable range for thyroid and adrenal hormones is in this age group following congenital heart surgery, to assess the association of low hormone levels and poor outcome measures, and to identify a group of patients for enrolment in future studies of hormone replacement.


Eligibility

Sex: Both males and femalesMax Age: 3 Monthss

Plain Language Summary

Simplified for easier understanding

This observational study follows babies under 3 months old after they have had heart surgery for a birth defect. It looks at how the body's hormone system — specifically the thyroid and adrenal glands — recovers after surgery. Very young babies are more vulnerable to complications after heart surgery, and understanding what normal hormone levels look like in this age group will help doctors provide better care and plan future treatment studies. Extra blood samples are taken from lines already in place — no extra needle sticks are needed. You may be eligible if: - Your baby has had heart surgery for a congenital (birth) heart defect - Your baby is under 3 months of age You may NOT be eligible if: - Your baby has a known thyroid or adrenal gland condition Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Thyroid and adrenal hormone concentrations decrease following congenital heart surgery, in older children this usually returns to normal after 1 week. This study will establish how quickly adrenal and

Thyroid and adrenal hormone concentrations decrease following congenital heart surgery, in older children this usually returns to normal after 1 week. This study will establish how quickly adrenal and thyroid hormone concentrations return to normal in infants less than 3 months of age following congential heart surgery, and whether there is any association between the amount of decrease or a delayed in adrenal / thyroid recovery and worse outcome. Nil intervention except short synacthen test for assessment of adrenal reserve.


Locations(1)

New Zealand

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ACTRN12607000072415