Thyroid Function in Term Infants With Respiratory Distress

Infant, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293956
• Other study ID #: 25190
• Status: Completed
• Phase: N/A
• First received: February 16, 2006
• Last updated: January 16, 2008
• Start date: January 2006
• Est. completion date: July 2006

Study information

• Verified date: January 2008
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Days

Eligibility

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

Exclusion Criteria:

• Infants born < 35 weeks gestation

• Infants with documented congenital abnormalities which directly impact the cardiorespiratory system

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infant, Newborn
• Transient Hypothyroxinemia

Locations

Country	Name	City	State
United States	Christiana Hospital	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

References & Publications (6)

Huang CB, Chen FS, Chung MY. Transient hypothyroxinemia of prematurity is associated with abnormal cranial ultrasound and illness severity. Am J Perinatol. 2002 Apr;19(3):139-47. — View Citation

Lim DJ, Herring MK, Leef KH, Getchell J, Bartoshesky LE, Paul DA. Hypothyroxinemia in mechanically ventilated term infants is associated with increased use of rescue therapies. Pediatrics. 2005 Feb;115(2):406-10. — View Citation

Paul DA, Leef KH, Voss B, Stefano JL, Bartoshesky L. Thyroxine and illness severity in very low-birth-weight infants. Thyroid. 2001 Sep;11(9):871-5. — View Citation

Richardson DK, Gray JE, McCormick MC, Workman K, Goldmann DA. Score for Neonatal Acute Physiology: a physiologic severity index for neonatal intensive care. Pediatrics. 1993 Mar;91(3):617-23. — View Citation

Simpson J, Williams FL, Delahunty C, van Toor H, Wu SY, Ogston SA, Visser TJ, Hume R; Scottish Preterm Thyroid Group. Serum thyroid hormones in preterm infants and relationships to indices of severity of intercurrent illness. J Clin Endocrinol Metab. 2005 Mar;90(3):1271-9. Epub 2004 Dec 21. — View Citation

Watterberg KL, Gerdes JS, Cook KL. Impaired glucocorticoid synthesis in premature infants developing chronic lung disease. Pediatr Res. 2001 Aug;50(2):190-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No