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Testosterone and Cortisol Levels in Infants

NCT02599545 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-04-12

No results posted yet for this study

Summary

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).

Conditions

  • Infant, Premature
  • Infant, Very Low Birth Weight

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Dr. June Cho, PhD, RN · Duke University School of Nursing

Eligibility

Min Age
1 Minute
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-02-02
Completion
2017-02-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02599545 on ClinicalTrials.gov