NCT03858127

Brief Summary

It is generally known that there are some hormonal changes during puberty, but the knowledge about the activation of the same hormonal axis in the first months of life is relatively recent and it is not completely understood. From the first weeks of life there is a progressive increase in hormone levels and this post-natal activation is called "minipuberty". Particularly in males, testosterone and androgen levels are associated with development and maturation of the reproductive system as well as changes in the brain structure and behaviours. Recently, it has also been suggested that the increasing testosterone level during the first 6 months of life, as well as during puberty, translates into an increase of linear growth. In preterm neonates these hormones rise higher and for longer than in full-term newborns, suggesting that its activity is evolutionarily regulated. With this study researchers would like to investigate these changes and correlate hormone levels with linear growth and neurobehavioral development of preterm infants.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 7, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

February 15, 2019

Last Update Submit

March 5, 2019

Conditions

Infant, Newborn

Outcome Measures

Primary Outcomes (2)

  • Measurement of urinary luteinising hormone

    Urinary LH measured every week on fresh samples using electro- chemiluminescence immunoassay (ECLIA). Sample analysis will be performed by the Biochemistry Department of the Royal Hospital for Children in Glasgow using Abbott Architect i1600 instrument

    18 months

  • Measurement of urinary follicle stimulating hormone

    Urinary FSH measured every week on fresh samples using electro- chemiluminescence immunoassay (ECLIA). Sample analysis will be performed by the Biochemistry Department of the Royal Hospital for Children in Glasgow using Abbott Architect i1600 instrument

    18 months

Secondary Outcomes (5)

  • Measurement of weight

    18 months

  • Measurement of occipital frontal circumference

    18 months

  • Measurement of penile growth

    18 months

  • Measurement of penile volume

    18 months

  • Video recording of fidgety movements

    18 months

Study Arms (1)

Male infants born <32 weeks gestation

Other: Collection of urine sampleOther: Examination of genitaliaOther: Video messaging

Interventions

Collection of urine sampleOTHER

Collection of urine sample for measurement of LH and FSH

Male infants born <32 weeks gestation
Examination of genitaliaOTHER

Examination of genitalia

Male infants born <32 weeks gestation
Video messagingOTHER

Short video of infant recorded at home by the parents

Male infants born <32 weeks gestation

Eligibility Criteria

AgeUp to 72 Hours
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale infants
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

We aim to enroll 20 neonates born under 32 weeks of gestational age at the Royal Hospital for Children in Glasgow. Neonates will be enrolled during the first 3 days of life with written informed consent signed by their parents.

You may qualify if:

  • Male preterm infants born ≤32 weeks of gestational age
  • Written informed consent provided

You may not qualify if:

  • Female sex assignment at birth
  • Male preterm infants born \>32 weeks of gestational age
  • Male infants born at term

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Paul Dearie

    NHS GGC R&D

    STUDY DIRECTOR

Central Study Contacts

Faisal Ahmed

CONTACT

07765422553faisal.ahmed@glasgow.ac.uk

Martina Rodie

CONTACT

07973887549martina.rodie@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 28, 2019

Study Start

March 1, 2019

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

March 7, 2019

Record last verified: 2019-02