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NCT05463120

Minipuberty of Infancy and the Timing of Pubertal Development in Adolescence: a Follow-up of the Infant Feeding and Early Development (IFED) Cohort

Enrolling by Invitation
Not specifiedAges 8+Observational
National Institute of Environmental Health Sciences (NIEHS)
~566 participants
Updated 2026-04-30 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess whether growth, timing of pubertal development, and hypothalamic-pituitary-gonadal (HPG) axis activity in childhood and adolescence are related to endogenous and exogenous endocrine-related factors during minipuberty of infancy.
Measured over Various time points in childhood/adolescence (study enrollment, 6-month and 12-month follow-up visits currently planned). We anticipate that children will be 8-12 years of age at enrollment (2022) and followed prospectively.

Conditions

Puberty

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GrowthPuberty

Where it's being run

2 sites across 2 states
Maryland1
North Carolina1

Study leadership

  • Dale P Sandler, Ph.D. · PRINCIPAL_INVESTIGATOR · National Institute of Environmental Health Sciences (NIEHS)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Central or peripheral precocious puberty
Delayed puberty
Growth hormone deficiency
Stunted or delayed growth
Idiopathic short stature
Hypopituitarism
Thyroid conditions, such as hyperthyroid, hypothyroid, Graves disease, Hashimoto's thyroiditis
Genetic conditions, such as Prader-Willi syndrome, Turner syndrome, and Noonan syndrome
Gonadotropin-Releasing Hormone Agonists (e.g., leuprolide acetate (Lupron Depot), triptorelin (Triptodur), histrelin implant (Supprelin LA))
Hormone therapy (e.g., testosterone, estrogen)
Synthetic human growth hormone or IGF-1
Synthetic thyroid hormone (e.g., levothyroxine)
Anti-thyroid medications (e.g., methimazole, propylthiouracil) or radioactive iodine treatment

What this trial measures

  • To assess whether growth, timing of pubertal development, and hypothalamic-pituitary-gonadal (HPG) axis activity in childhood and adolescence are related to endogenous and exogenous endocrine-related factors during minipuberty of infancy.Various time points in childhood/adolescence (study enrollment, 6-month and 12-month follow-up visits currently planned). We anticipate that children will be 8-12 years of age at enrollment (2022) and followed prospectively.

    1)Growth in height, weight and body mass index 2)Onset of pubic hair development, breast development (females), genital development (males) 3)Urinary concentrations of reproductive hormone metabolites (e.g., gonadotropins, estradiol, testosterone)