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

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Dysfunction

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Hanaa Abdellatif, Professor; Phone Number: 01064747613; Email: Hanaa.hassan1@med.au.edu.eg
• Study Contact Backup: Name: Mohamed Gamil, Lecturer; Phone Number: 01024741834; Email: mohamedgamilmohamed@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Heba Ali
    • Contact: Hanaa Abdellatif, Professor; Phone Number: 01064747613; Email: Hanaa.hassan1@med.au.edu.eg
    • Contact: Mohamed Gamil, Lecturer; Phone Number: 01024741834; Email: mohamedgamilmohamed@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thyroid function	TSH level free T3 freeT4	10 days

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful 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).

Study record dates

Study Major Dates

• Study Start (Anticipated): December 17, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: TFPTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No