Testosterone and Cortisol Levels in Infants



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:October 2015
End Date:May 2019
Contact:Dr. June Cho, PhD, RN
Email:june.cho@dm.duke.edu
Phone:919-684-3786

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Testosterone and Cortisol Levels in Infant Health and Development

Very low birth weight (VLBW) infants have more health and developmental problems than normal
birth weight full-term infants. These problems are more common in males than female VLBW
preterm infants. Male VLBW infants also experience less positive mother-infant interactions
than females, especially when mothers are emotionally distressed. This is a significant
problem because positive mother-infant interactions function as an important protective
factor against the negative health and developmental outcomes associated with prematurity.
The source of the vulnerability of male VLBW infants to health problems, suboptimal
mother-infant interactions, and poor development goes beyond gender socialization
differences and includes biological factors. Identification of infant and maternal
biological markers/predictors of infant health and developmental outcomes could ultimately
lead to interventions for VLBW preterm infants.

The purpose of this study is to confirm that testosterone rather than cortisol is a more
reliable marker/predictor of complications affecting infants' health outcomes, mother-infant
interactions, and infant cognitive/motor/language developmental outcomes; and that male
infants exhibit a higher sensitivity to testosterone levels than female infants.

This longitudinal study will examine the associations of the steroid hormones, testosterone
and cortisol, levels with infant health, mother-infant interactions, and infant
cognitive/motor/language development ('infant development') in very low birthweight (VLBW,
BW < 1,500 g) preterm (gestational age < 32 weeks gestation) infants after adjusting for
maternal physical and mental health state, infant socioemotional and behavioral development,
and characteristics of infants and mothers. Concurrent and repeated measurement of
testosterone and cortisol levels both in infants and mothers will be conducted through
infancy and early childhood (at birth, 40 weeks postmenstrual age, 12 and 24 months
corrected age).


Inclusion Criteria:

- Neonates will be included if they are less than or equal to 32/0 weeks gestational
age at birth and have a birth weight < 1500 grams.

- Mothers will be included if they are (1) older than 15 years, (2) able to communicate
in English or Spanish, (3) primary caregivers of the newborn.

Exclusion Criteria:

- Neonates will be excluded if they (1) are born > 32/0 weeks GA, (2) weigh more than
1,500 grams at birth, (3) have congenital abnormalities, (2) will be discharged
before day 7 of life, (3) have a positive urine drug screen, or (4) are being placed
for adoption after discharge from the hospital.

- Mothers will be excluded if they have (1) narcotic or injection drug dependence or
(2) a documented serious health (e.g., cancer or HIV positive) or psychological
(e.g., schizophrenia) problem.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-684-3786
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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