An observational study in Transient Hypothyroxinemia and Infant, Newborn, sponsored by Christiana Care Health Services. Completed at 1 site in United States. Open to participants aged Up to 6 Days. Per ClinicalTrials.gov, last updated 2008-01-18.
Sponsored by Christiana Care Health Services · Observational
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.
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 infant's 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.
967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.
This study's enrollment of 20 is below the median of 150 across 381 observational studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Full-term and near-term infants with respiratory distress during the first 24 hours of life.
Exclusion Criteria:
Full-term and near-term infants with respiratory distress in the first 24 hours of life
To determine if thyroid function, particularly free T4, is associated with severity of illness in term and near term infants with respiratory distress who require endotracheal intubation or nasal CPAP.
Time frame: Birth until 120 hours of life
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Christiana Care Health Services