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

NCT05463120 | Enrolling By Invitation

• 2 other identifiers: 10000945000945-E
• Study Type: observational
• Target: 566
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Puberty

Keywords

Childhood; Growth; Adolescence; Hormone; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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.

Study Arms (1)

IFED-2

Children who participated in the IFED study as infants (2010-2014) and a parent/guardian will be enrolled in this follow-up study in childhood and followed for at least one year.

Eligibility Criteria

• Age: 8 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The eligible population includes 283 children (136 girls, 147 boys), and their mothers or other parent/guardian, who completed the original IFED study, conducted when the children where 0-9 months of age (2010-2014).

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Completion of the original IFED study, defined as participants who did not withdraw from the study or were not withdrawn by the investigator prior to the end of original follow-up (up to 7 months in males and 9 months in females) and who provided at least the minimum number of blood samples (3 for boys, 4 for girls) across the original study period (N=283 eligible families).
• Ability of subject and mother to understand and the willingness to review informed assent and consent documents, respectively, and indicate agreement to participate.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (2)

National Institute of Environmental Health Sciences (NIEHS)

Bethesda, Maryland, 20892, United States

Location

Social & Scientific Systems

Durham, North Carolina, 27703, United States

Location

Study Officials

• Dale P Sandler, Ph.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 18, 2022
• Study Start: October 10, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04-28

Locations

US (2)