Thyroid Function in Term Infants With Respiratory Distress

Sponsor

Christiana Care Health Services (Other)

Overall Status

Completed

CT.gov ID

NCT00293956

Collaborator

(none)

Enrollment

Location

5.9

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transient Hypothyroxinemia Infant, Newborn

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 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.

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Thyroid Function in Term and Near Term Infants With Respiratory Distress and Its' Relation to Severity of Illness

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
1 Full-term and near-term infants with respiratory distress in the first 24 hours of life

Outcome Measures

Primary Outcome Measures

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. [Birth until 120 hours of life]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 6 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Infants born > or = to 35 weeks gestation
Infants admitted to the neonatal intensive care unit at Christiana Hospital
Respiratory distress requiring use of mechanical ventilation or nasal CPAP (continuous positive airway pressure)
Parental informed consent