Transient HypothyroxinemiaNCT00293956
Thyroid Function in Term Infants With Respiratory Distress
An observational study of Transient Hypothyroxinemia and Infant, Newborn, run by Christiana Care Health Services at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 6 days
- Conditions the study is for
- Transient Hypothyroxinemia, Infant, Newborn
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jul 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 days
- All sexes
- No healthy volunteers
- Child
Study population: Full-term and near-term infants with respiratory distress during the first 24 hours of life.
Who may be able to join
- 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
Who cannot join
- Infants born < 35 weeks gestation
- Infants with documented congenital abnormalities which directly impact the cardiorespiratory system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyroid Function in Term and Near Term Infants With Respiratory Distress and Its' Relation to Severity of Illness
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.
Read the 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.
- Conditions
- Transient Hypothyroxinemia, Infant, Newborn
- Keywords
- hypothyroxinemia, full term infants, near term infants, respiratory distress, thyroid disease
- Medical subject headings
- Dyspnea, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Full-term and near-term infants with respiratory distress in the first 24 hours of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Birth until 120 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Transient HypothyroxinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Investigators
- David A. Paul, MD, Principal investigator, Christiana Care Health SystemsErika M. Yencha, MD, Principal investigator, Christiana Care Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293956
- Sponsor's protocol ID
- 25190
- Status last verified
- Jan 2008
- First submitted
- 16 Feb 2006
- Last updated
- 18 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1055/s-2002-25308.
PubMed 12012289Paul 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. doi: 10.1089/105072501316973136.
PubMed 11575857Lim 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. doi: 10.1542/peds.2004-0192.
PubMed 15687450Watterberg KL, Gerdes JS, Cook KL. Impaired glucocorticoid synthesis in premature infants developing chronic lung disease. Pediatr Res. 2001 Aug;50(2):190-5. doi: 10.1203/00006450-200108000-00005.
PubMed 11477202Simpson 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. doi: 10.1210/jc.2004-2091. Epub 2004 Dec 21.
PubMed 15613404Richardson 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.
PubMed 8441569
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Function in Term and Near Term Infants With Respiratory Distress and Its' Relation to Severity of Illness
- ClinicalTrials.gov ID
- NCT00293956
- Acronym / sponsor ID
- 25190
- Conditions
- Transient Hypothyroxinemia, Infant, Newborn
- Keywords
- hypothyroxinemia, full term infants, near term infants, respiratory distress, thyroid disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 20 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Full-term and near-term infants with respiratory distress in the first 24 hours of life |
Who may qualify
- Ages
- Up to 6 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Full-term and near-term infants with respiratory distress during the first 24 hours of life.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Infants born < 35 weeks gestation
- Infants with documented congenital abnormalities which directly impact the cardiorespiratory system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2008.
- Background: PubMed 12012289Huang 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. doi: 10.1055/s-2002-25308.
- Background: PubMed 11575857Paul 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. doi: 10.1089/105072501316973136.
- Background: PubMed 15687450Lim 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. doi: 10.1542/peds.2004-0192.
- Background: PubMed 11477202Watterberg KL, Gerdes JS, Cook KL. Impaired glucocorticoid synthesis in premature infants developing chronic lung disease. Pediatr Res. 2001 Aug;50(2):190-5. doi: 10.1203/00006450-200108000-00005.
- Background: PubMed 15613404Simpson 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. doi: 10.1210/jc.2004-2091. Epub 2004 Dec 21.
- Background: PubMed 8441569Richardson 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Paul, MD principal investigator
Christiana Care Health Systems
Erika M. Yencha, MD principal investigator
Christiana Care Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transient Hypothyroxinemia and Infant, Newborn, run by Christiana Care Health Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00293956, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2008.