Transient Hypothyroxinemia of PrematurityNCT05901623

ASQ Scores of Transient Hypothyroxinemia of Prematurity

An observational study of Transient Hypothyroxinemia of Prematurity and Neurodevelopmental Abnormality, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Transient hypothyroxinemia of prematurity (THoP) is defined as free thyroxine (FT4) level is below the reference values despite normal TSH level in preterm infant. This study aims to evaluate the neurological development of infants with transient premature hypothyroxinemia (THoP). Read more about this study

Who is it for?: Ages Up to 1 monthHealthy volunteers can take part
Conditions the study is for: Transient Hypothyroxinemia of Prematurity, Neurodevelopmental Abnormality
What is being tested?: 'Ages and Stages Questionnaries' (ASQ)
How many people: 70 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Feb 2021to 1 Feb 2023
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 1 month
All sexes
Healthy volunteers accepted
Child

Study population: This study included newborn infants born at 28-36 gestational weeks, with a diagnosis of transient hypothyroxinemia of prematurity, and hospitalized in the neonatal intensive care unit. Healthy age-matched infants were included in the control group.

Who may be able to join

newborn infants who were born at 28-36 gestational weeks
Infants who were hospitalized in the neonatal intensive care unit
Infants with transient hypothyroxinemia of prematurity

Who cannot join

Newborns with maternal thyroid disease,
Severe intracranial issues,
Chromosomal and congenital anomalies,
Infants older than 36 gestational weeks

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34303

Other trials in Turkey (Türkiye)

About this study

Official title: Neurodevelopmental Outcome of the Infants With Transient Hypothyroxinemia of Prematurity in Newborn Intensive Care Unit

Transient hypothyroxinemia of prematurity (THoP) is defined as free thyroxine (FT4) level is below the reference values despite normal TSH level in preterm infant. This study aims to evaluate the neurological development of infants with transient premature hypothyroxinemia (THoP).

Conditions: Transient Hypothyroxinemia of Prematurity, Neurodevelopmental Abnormality
Being tested: 'Ages and Stages Questionnaries' (ASQ)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

'Ages and Stages Questionnaries' (ASQ)Other
Also called 'Ages and Stages Questionnaries: Social-Emotional' (ASQ:SE) Inventories
''ASQ' is a screening tool for assessing the development of infants and preschoolers in the areas of communication, fine motor, gross motor, problem-solving and personal-social development, and 'ASQ:SE' is a screening tool for social-emotional development

Study groups in NCT05901623
Study group	Role	What they receive
Case		Infants with THoP Receives: Other: 'Ages and Stages Questionnaries' (ASQ)
Control		Healthy infants Receives: Other: 'Ages and Stages Questionnaries' (ASQ)

What is being measured

The primary outcome is the main question the study is designed to answer.

Long-term Neurodevelopment
'Ages And Stages Questionnaires' (ASQ) 'Ages And Stages Questionnaires: Social-Emotional' (ASQ:SE) Developmental Screening Tests evaluates the areas of communication, fine motor, gross motor, problem-solving and personal-social development. ASQ score differs 0-60 and results are interpreted in three group according to the gained points as normal, risky, and follow-up required.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20211 Feb 2023

First posted13 Jun 2023
Study start1 Feb 2021
Primary completion1 Mar 2022
Study completion1 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Transient Hypothyroxinemia of PrematurityStudies 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: Case-control
Time perspective: Cross-sectional
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05901623
Sponsor's protocol ID: 2022-20-05
Status last verified: Jun 2023
First submitted: 5 Jun 2023
Last updated: 15 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurodevelopmental Outcome of the Infants With Transient Hypothyroxinemia of Prematurity in Newborn Intensive Care Unit
ClinicalTrials.gov ID: NCT05901623
Acronym / sponsor ID: 2022-20-05
Conditions: Transient Hypothyroxinemia of Prematurity, Neurodevelopmental Abnormality
Study type: Observational
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
Study start: 1 Feb 2021 (actual)
Primary completion: 1 Mar 2022 (actual)
Study completion: 1 Feb 2023 (actual)
First posted: 13 Jun 2023 (actual)
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 of prematurity (THoP) is defined as free thyroxine (FT4) level is below the reference values despite normal TSH level in preterm infant. This study aims to evaluate the neurological development of infants with transient premature hypothyroxinemia (THoP).

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Case	–	Other: 'Ages and Stages Questionnaries' (ASQ)Infants with THoP
Control	–	Other: 'Ages and Stages Questionnaries' (ASQ)Healthy infants

Who may qualify

Ages: Up to 1 month
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: This study included newborn infants born at 28-36 gestational weeks, with a diagnosis of transient hypothyroxinemia of prematurity, and hospitalized in the neonatal intensive care unit. Healthy age-matched infants were included in the control group.

Key inclusion criteria (3 listed)

newborn infants who were born at 28-36 gestational weeks
Infants who were hospitalized in the neonatal intensive care unit
Infants with transient hypothyroxinemia of prematurity

Key exclusion criteria (4 listed)

Newborns with maternal thyroid disease,
Severe intracranial issues,
Chromosomal and congenital anomalies,
Infants older than 36 gestational weeks

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
'Ages and Stages Questionnaries' (ASQ)Also: 'Ages and Stages Questionnaries: Social-Emotional' (ASQ:SE) Inventories''ASQ' is a screening tool for assessing the development of infants and preschoolers in the areas of communication, fine motor, gross motor, problem-solving and personal-social development, and 'ASQ:SE' is a screening tool for social-emotional development	Other	Case, Control

Primary outcome

Long-term Neurodevelopment
Time frame: 5 years
'Ages And Stages Questionnaires' (ASQ) 'Ages And Stages Questionnaires: Social-Emotional' (ASQ:SE) Developmental Screening Tests evaluates the areas of communication, fine motor, gross motor, problem-solving and personal-social development. ASQ score differs 0-60 and results are interpreted in three group according to the gained points as normal, risky, and follow-up required.

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 15 Jun 2023.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

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 of Prematurity and Neurodevelopmental Abnormality, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).

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 3 inclusion and 4 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 15 Jun 2023. 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 Turkey (Türkiye). 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?

Long-term Neurodevelopment (time frame: 5 years). 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 NCT05901623.

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 15 Jun 2023.