Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293956
Status:
COMPLETED
Last Update Posted:
2008-01-18
First Post:
2006-02-16
Brief Title:
Thyroid Function in Term Infants With Respiratory Distress
Sponsor:
Christiana Care Health Services
Organization:
Christiana Care Health Services
Study Overview
Official Title:
Thyroid Function in Term and Near Term Infants With Respiratory Distress and Its Relation to Severity of Illness
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to evaluate the level of certain hormones thyroid hormones and cortisol in full term or close to full term infants who have respiratory distress severe enough to require respiratory support The purpose of this study is to determine if there is a relationship between these hormone levels and how sick these infants are who require help with breathing following birth
Hypothesis Infants who are born full term or near full term and who have low hormone levels will have higher severity of illness
Hypothesis Infants who are born full term or near full term and who have low hormone levels will have higher severity of illness
Detailed Description:
Transient hypothyroxinemia as demonstrated by low T4 and free T4 levels with normal levels of TSH in preterm infants has been associated with increased severity of illness and adverse outcomes Effects of thyroid function in term infants is less well studied Previous research in the Special Care Nursery at Christiana Hospital has indicated that transient hypothyroxinemia in intubated term infants was associated with increased severity of illness and the need for more intensive rescue therapies However free T4 the biologically active substance was not measured in our previous study
Infants who meet criteria for the study will begin participation after parental informed consent is obtained Infants who are enrolled will have serial measurements of thyroid stimulating hormone TSH T4 free T4 free T3 and cortisol These measurements will be obtained at four specific time intervals throughout the first week of the infants life The medical team will be blinded to the results of the hormone testing The results will be reviewed by an unblinded study investigator and an endocrinologist will be consulted if abnormal results are reported
These hormone levels will be compared with severity of illness and level of respiratory support needed in order to establish an association between thyroid function and illness severity Illness severity will be quantified by using the Score for Neonatal Acute Physiology SNAP SNAP scores require collecting data from vital signs and results of labs that are considered standard of care
Infants who meet criteria for the study will begin participation after parental informed consent is obtained Infants who are enrolled will have serial measurements of thyroid stimulating hormone TSH T4 free T4 free T3 and cortisol These measurements will be obtained at four specific time intervals throughout the first week of the infants life The medical team will be blinded to the results of the hormone testing The results will be reviewed by an unblinded study investigator and an endocrinologist will be consulted if abnormal results are reported
These hormone levels will be compared with severity of illness and level of respiratory support needed in order to establish an association between thyroid function and illness severity Illness severity will be quantified by using the Score for Neonatal Acute Physiology SNAP SNAP scores require collecting data from vital signs and results of labs that are considered standard of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None