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

NCT05632965 | Unknown

• 1 other identifier: TFPTI
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Dysfunction

Outcome Measures

Primary Outcomes (1)

• Thyroid function

  TSH level free T3 freeT4

  10 days

Study Arms (2)

Healthy preterm infants

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

Sick preterm infants

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

Eligibility Criteria

• Age: 3 Days - 10 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

all cases of preterm infants fulfilling the inclusion criteria attending Neonatal Intensive Care unit at Assiut University children Hospital during one year.

You may qualify if:

• 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 .

You may not qualify if:

• preterm infants with : • fetal congenital malformations.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Heba Ali

Asyut, Egypt

RECRUITING

Related Links

• 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).

Central Study Contacts

Hanaa Abdellatif, Professor

CONTACT

01064747613; Hanaa.hassan1@med.au.edu.eg

Mohamed Gamil, Lecturer

CONTACT

01024741834; mohamedgamilmohamed@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: February 17, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 15, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)