Clinical Trial: COPENHAGEN Minipuberty Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: COPENHAGEN Minipuberty Study
Brief Summary:
Minipuberty is a term used to describe the transient activation of the pituitary-gonadal axis 2-3 months after birth in both boys and girls. It is, however, not known why infants reach adult levels of reproductive hormones in early life, nor is the exact timing of the peak known. Furthermore, what determines the timing of peaks and suppressions of reproductive hormones from infancy throughout childhood and into adolescence remains to be elucidated.
The study aims to described and evaluate dynamic changes in the hypothalamic-pituitary- gonadal axis in early postnatal life.
Detailed Summary:
Minipuberty is a term used to describe the transient activation of the pituitary-gonadal axis 2-3 months after birth in both boys and girls. It is, however, not known why infants reach adult levels of reproductive hormones in early life, nor is the exact timing of the peak known. Furthermore, what determines the timing of peaks and suppressions of reproductive hormones from infancy throughout childhood and into adolescence remains to be elucidated.
Few studies have investigated minipuberty and one, for example, found that it is affected in premature infants (before gestation week 37). However, no studies on normative data throughout minipuberty in infants exist.
Furthermore, using minipuberty as a window for diagnosis of endocrine disorders and future reproductive function has been suggested. Defining minipuberty, both in terms of circulating hormone levels and urinary metabolites, in healthy infants is therefore essential in order to utilize this window. Studies using patients with Disorders of Sex Development during minipuberty have been carried out, but they are hampered by small sample sizes and lack of control groups.
In addition, little is known about the genetic and epigenetic factors that drive the onset, progression and termination of minipuberty as well as the actual puberty, i.e. the factors responsible for the quiescence of the HPG axis during childhood and the dis-inhibition responsible for pubertal onset. Therefore, much attention was drawn on the study performing whole exome sequencing in patients and relatives with central precocious puberty (CPP). For the first time, MKRN3 was suggested as the primary factor responsible for HPG inhibition during mid-childhood. A number of studies support that MKRN3 mutations cause CPP, and genetic variation of MKRN3 affect
Sponsor: Rigshospitalet, Denmark
Current Primary Outcome:
- Serum and urinary metabolites of reproductive hormones (e.g. steroid hormone metabolites and gonadotropins) (newborn) [ Time Frame: 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth plus 40 days daily measurement (urine, female 40 days diaper study subgroup) ]change/course serum and urinary metabolites
- Urinary metabolites of endocrine disrupting chemicals (e.g. phthalates, phenols, perfluorinated compounds and parabens) (newborn) [ Time Frame: 3-7d, & 1,3,5,7,12m or 2,4,6,8,12m after birth plus 40 days daily measurement (urine, female 40 days diaper study subgroup) ]change/course urinary metabolites
- Basic clinical examination (newborn) (size and proportions) [ Time Frame: 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth ]change/course: measurements of length, weight, skin folds and hip-waist ratio
- Basic clinical examination (newborn) (pubertal staging) [ Time Frame: 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth ]change/course: pubertal staging using Tanners classification (including testicular size in boys assessed by Prader's orchidometer and ultrasound
- Basic clinical examination (newborn) (genitalia) [ Time Frame: 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth ]change/course: classification of external genitalia (classification of genital tubercle, location of gonads, position of urethra, labia/scrotal fusion)
- Basic clinical examination (newborn) (penile measureme
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Basic clinical examination (parents) (height) [ Time Frame: postpartal (within first 3 months) ]Height
- Basic clinical examination (parents) (weight) [ Time Frame: postpartal (within first 3 months) ]self-reported pre-pregnancy weight for the mother and postpartal weight of the father
- Basic clinical examination (parents) [ Time Frame: postpartal (within first 3 months) ]Skinfolds measured above the biceps, triceps, at the flank, and below the scapula
- Pregnancy and perinatal outcome (newborn and mother) [ Time Frame: before birth and perinatal phase ]Perinatal outcome including birth weight, -length, partus mode, adverse events/complications, pre- and perinatal drug intake, pregnancy outcomes including gestational age, pregnancy complications, IVF Treatment etc.
- Medical history and exposure (parents) (basic) [ Time Frame: postpartal (within first year) ]Basic medical history (parents) (questionaire / journal)
- Medical history and exposure (parents) (obstetrical) [ Time Frame: postpartal (within first year) ]Obstetrical history including outcomes of previous pregnancies and births (mother), smoking and drug intake during pregnancy (mother) (questionaire / journal)
- Medical history and exposure (parents) (puberty) [ Time Frame: postpartal (within first year) ]Pubertal history (parents) including age at menarche, pubertal timing with regard to peers, age at menopause of the mother of the parents etc. (questionaire)
- Breastfeeding and food intake (newborn) [ Time Frame: first year of life ]change/course: breastfeeding and food intake of the newborn during the course of the first year (questionaire)
Original Secondary Outcome: Same as current
Information By: Rigshospitalet, Denmark
Dates:
Date Received: May 17, 2016
Date Started: August 2016
Date Completion: October 2017
Last Updated: August 4, 2016
Last Verified: August 2016
- Basic clinical examination (parents) (height) [ Time Frame: postpartal (within first 3 months) ]
