Thyroid Function in Sick and Healthy Preterm Infants Admitted in NICU of Assiut University Children Hospital

NCT ID: NCT05632965

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-17

Study Completion Date

2023-12-15

Brief Summary

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Thyroid hormones are the cornerstones of a complex system that plays an important role in the growth and development of children, especially in the development of the nervous system and brain. Therefore, even minimal disruptions of this system can cause permanent damage.

Thyroid dysfunction is a common problem in pre-term infants. Hypothyroxinemia of prematurity within the first month of life may represent important prognostic information about morbidity and mortality. Thyroid hormone synthesis may be disrupted in co-morbid conditions . worsening the metabolism of premature infants and causing higher hormone levels compared to healthy infants.

Detailed Description

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The most common thyroid function disorder in premature infants is physiological hypothyroxinemia, followed by hypothyroidism of non-thyroidal causes. In pre-maturity, several factors can inhibit the conversion of peripheral T4 to T3, including hypoxemia, acidosis, infections, hypoglycemia, hypocalcemia and malnutrition . Some rare conditions include transient secondary/tertiary hypothyroidism, transient primary hypothyroidism and permanent primary hypothyroidism.

Thyroid dysfunction has been reported to be more common in infants with low birth weight due to inadequate intrauterine nutrition, hypoxia, and acidosis.In addition, a meta-analysis found that birth weight and gestation week age closely related to thyroid function tests. Plasma T4, FT4, T3, rT3, (thyroid stimulating hormone), and (thyroxin binding globulin) concentrations during the first 8 weeks after birth in infants of 28-30 weeks gestation and in infants of \<28 weeks gestation.

Conditions

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Thyroid Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy preterm infants

Thyroid function in Preterm infants not needing hospital admission will be estimated at day 3 and day 10 of life.

No interventions assigned to this group

Sick preterm infants

Thyroid function in sick preterm infants admitted to NICU will be estimated at day 3 and day 10 of life .

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All preterm infants (\<37w gestational age) admitted to NICU unit of assiut university children hospital with various problems as : •respiratory distress

* hypoxia
* sepsis
* necrotizing enterocolitis
* receiving TPN (total parental nutrition)
* infants presented with jaundice.
* Another group of healthy preterm of comparable gestational age not complaining from any problems coming to routine postnatal checkup and outpatient clinic of neonatal unit will be taken .

Exclusion Criteria

* preterm infants with : • fetal congenital malformations.
Minimum Eligible Age

3 Days

Maximum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Heba Ali Nahall

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Heba Ali

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hanaa Abdellatif, Professor

Role: CONTACT

01064747613

Mohamed Gamil, Lecturer

Role: CONTACT

01024741834

Facility Contacts

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Hanaa Abdellatif, Professor

Role: primary

01064747613

Mohamed Gamil, Lecturer

Role: backup

01024741834

Related Links

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https://doi.org/10.1203/00006450-199711000-00009

Van Wassenaer, A., Kok, J., Dekker, F. et al. Thyroid Function in Very Preterm Infants: Influences of Gestational Age and Disease. Pediatr Res 42, 604-609 (1997).

Other Identifiers

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TFPTI

Identifier Type: -

Identifier Source: org_study_id

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