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

Conditions studied: Puberty

In brief

Background: Earlier puberty is associated with adverse health throughout a person s life. The average age when puberty begins has been declining over the past decades in girls, and may also be declining in boys. The reasons for this shift are unknown. Objective: To determine whether internal (physical, hormonal) or external (feeding, environment) factors during infancy affect growth and the timing of puberty. Eligibility: Mothers (or other parent/guardian) and their children who completed the Infant Feeding and Early Development (IFED) study. Design: Participants will complete all activities at home for this natural history study. Participant mothers will fill out two 15-minute questionnaires: * One will be about themselves. They will answer questions about their body size in childhood, their puberty, and their pregnancies. * The other will be about their child. They will answer questions about their child s puberty and lifestyle. Child participants will fill out a questionnaire about their body changes during puberty. This will take 10 minutes. Participants will be sent an electronic scale and a measuring tape. They will measure the child s weight, height, and waist and hip circumference. These numbers can be submitted online or by phone or mail. Participants will receive a kit for collecting urine samples. Child participants will collect urine in a cup upon waking 4 days in a row. A special filter card is dipped in the cup then hung to dry. The dried cards will be mailed back. Participants will allow researchers to access their child s medical records. Questionnaires and body measurements will be repeated after 6 and 12 months. Urine sample collection will be repeated after 12 months. All questionnaires can be done either online, by mail, or by phone on request.

Key facts

Study ID

NCT05463120

Run by

National Institute of Environmental Health Sciences (NIEHS)

People needed

566

Starts

2022-10-10

Expected to finish

2027-03-01

Last updated by the study team

2026-04-30

Who can join

Age: 8 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• We will not exclude any participants that meet the inclusion criteria from participating in the study overall or in any of the study procedures. We will collect information, via maternal report and linked medical records, on relevant medical diagnoses and the use of medications that may affect hormone levels, growth, and pubertal development. We may exclude participants with reported conditions or medication use (listed below) from analyses of some study aims or in sensitivity analyses.
• Diagnoses/conditions:
• 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
• Medications:
• 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

Where it is running

• National Institute of Environmental Health Sciences (NIEHS) — Bethesda, Maryland, United States
• Social & Scientific Systems — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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