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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05632965
Collaborator
(none)
80
Enrollment
1
Location
11.9
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Thyroid Function in Sick and Healthy Preterm Infants Admitted in NICU of Assiut University Children Hospital
    Anticipated Study Start Date :
    Dec 17, 2022
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Dec 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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 .

    Outcome Measures

    Primary Outcome Measures

    1. Thyroid function [10 days]

      TSH level free T3 freeT4

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Days to 10 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heba Ali Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Heba Ali Nahall, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05632965
    Other Study ID Numbers:
    • TFPTI
    First Posted:
    Dec 1, 2022
    Last Update Posted:
    Dec 2, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thyroid Diseases

    Study Results

    No Results Posted as of Dec 2, 2022