Transient HypothyroxinemiaNCT00971555
Thyroid Function in Late Preterm Infants
An observational study of Transient Hypothyroxinemia, run by Christiana Care Health Services at 1 site in United States.
Trial summary
Transient hypothyroxinemia (TH) is a condition characterized by low levels of serum thyroxine (T4) and normal levels of thyroid stimulating hormone (TSH). TH in premature infants has been found to be related to severity of illness. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Transient Hypothyroxinemia
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2011
- 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 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Late preterm infants
Who may be able to join
- any infant born between 34 0/7 weeks and 36 6/7 weeks gestation born at Christiana Hospital
Who cannot join
- outborn infants
- infants with major congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyroid Function in Late Preterm Infants in Relation to Severity of Illness
Transient hypothyroxinemia (TH) is a condition characterized by low levels of serum thyroxine (T4) and normal levels of thyroid stimulating hormone (TSH). TH in premature infants has been found to be related to severity of illness. T4 levels in very low birth weight infants born prematurely has been found to be inversely correlated to severity of illness. In very low birth weight infants, TH has been associated with poor outcomes. Little is known about thyroid function in late preterm infants.
Hypotheses:
- Ill late preterm infants will have lower total T4 levels than healthy late preterm infants.
- Total T4 and possibly TSH levels will be inversely correlated with short-term outcomes.
- Late Preterm infants born by cesarean section will have lower T4 levels compared to those born by vaginal birth.
- Conditions
- Transient Hypothyroxinemia
- Keywords
- Transient Hypothyroxinemia, Late Preterm Infants, Total T4, TSH, Illness severity, NICU
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 |
|---|---|---|
| Late preterm | Late preterm infants admitted to the NICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery.
Measured: First week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Investigators
- Renee M Behme, MD, Principal investigator, Christiana HospitalDavid A Paul, MD, Principal investigator, Christiana Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971555
- Sponsor's protocol ID
- CCC#29111
- Status last verified
- Mar 2011
- First submitted
- 2 Sep 2009
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Behme RM, Mackley AB, Bartoshesky L, Paul DA. Thyroid function in late preterm infants in relation to mode of delivery and respiratory support. J Pediatr Endocrinol Metab. 2014 May;27(5-6):425-30. doi: 10.1515/jpem-2013-0243.
PubMed 24259241
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Function in Late Preterm Infants in Relation to Severity of Illness
- ClinicalTrials.gov ID
- NCT00971555
- Acronym / sponsor ID
- CCC#29111
- Conditions
- Transient Hypothyroxinemia
- Keywords
- Transient Hypothyroxinemia, Late Preterm Infants, Total T4, TSH, Illness severity, NICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Sep 2009 (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.
Transient hypothyroxinemia (TH) is a condition characterized by low levels of serum thyroxine (T4) and normal levels of thyroid stimulating hormone (TSH). TH in premature infants has been found to be related to severity of illness. T4 levels in very low birth weight infants born prematurely has been found to be inversely correlated to severity of illness. In very low birth weight infants, TH has been associated with poor outcomes. Little is known about thyroid function in late preterm infants.
Hypotheses:
- Ill late preterm infants will have lower total T4 levels than healthy late preterm infants.
- Total T4 and possibly TSH levels will be inversely correlated with short-term outcomes.
- Late Preterm infants born by cesarean section will have lower T4 levels compared to those born by vaginal birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Late preterm | – | –Late preterm infants admitted to the NICU |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Late preterm infants
Key inclusion criteria (1 listed)
- any infant born between 34 0/7 weeks and 36 6/7 weeks gestation born at Christiana Hospital
Key exclusion criteria (2 listed)
- outborn infants
- infants with major congenital anomalies
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
Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery.
Time frame: First week 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 23 Mar 2011.
- Derived from this study: PubMed 24259241Behme RM, Mackley AB, Bartoshesky L, Paul DA. Thyroid function in late preterm infants in relation to mode of delivery and respiratory support. J Pediatr Endocrinol Metab. 2014 May;27(5-6):425-30. doi: 10.1515/jpem-2013-0243.
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.
Renee M Behme, MD principal investigator
Christiana Hospital
David A Paul, MD principal investigator
Christiana Hospital
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, 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 1 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 23 Mar 2011. 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?
Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery. (time frame: First week 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 NCT00971555, which also lists 1 linked publication.
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 23 Mar 2011.