Thyroid Function in Term Infants With Respiratory Distress - Full Text View

Sponsored by:	Christiana Care Health Services
Information provided by:	Christiana Care Health Services
ClinicalTrials.gov Identifier:	NCT00293956

Purpose

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
Transient Hypothyroxinemia Infant, Newborn

Drug Information available for: Thyroid

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Thyroid Function in Term and Near Term Infants With Respiratory Distress and Its' Relation to Severity of Illness

Further study details as provided by Christiana Care Health Services:

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. [ Time Frame: Birth until 120 hours of life ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood, serum

Enrollment:	20
Study Start Date:	January 2006
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Full-term and near-term infants with respiratory distress in the first 24 hours of life

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.

Eligibility

Ages Eligible for Study:	up to 6 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Full-term and near-term infants with respiratory distress during the first 24 hours of life.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293956

Locations

United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718

Sponsors and Collaborators

Christiana Care Health Services

Investigators

Principal Investigator:	David A. Paul, MD	Christiana Care Health Systems
Principal Investigator:	Erika M. Yencha, MD	Christiana Care Health Systems

More Information

Publications:

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.

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.

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.

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

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.

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.

Responsible Party:	Christiana Hospital ( David A. Paul, MD )
Study ID Numbers:	25190
Study First Received:	February 16, 2006
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00293956 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:

hypothyroxinemia
full term infants
near term infants
respiratory distress
thyroid disease

Study placed in the following topic categories:

Thyroid Diseases

ClinicalTrials.gov processed this record on May 07, 2009