Thyroid Function in Term Infants With Respiratory Distress

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00293956
First received: February 16, 2006
Last updated: January 16, 2008
Last verified: January 2008
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: David A. Paul, MD, Christiana Hospital
ClinicalTrials.gov Identifier: NCT00293956     History of Changes
Other Study ID Numbers: 25190
Study First Received: February 16, 2006
Last Updated: January 16, 2008
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

ClinicalTrials.gov processed this record on July 29, 2014