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NCT02599545 · ClinicalTrials.gov registry record
Testosterone and Cortisol Levels in Infants
A clinical trial, sponsored by Duke University.
- Terminated
- Registry status
- 300
- Enrollment target
NCT02599545 is a clinical trial that was terminated before completion, run by Duke University. The registered enrollment target is 300 participants.
The verdict
NCT02599545 was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- 300 participants
- Enrollment target
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).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-02-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02599545
The ClinicalTrials.gov registry entry for NCT02599545 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02599545 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02599545 about?
NCT02599545 is a clinical study titled "Testosterone and Cortisol Levels in Infants". 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 w...
What is the current status of trial NCT02599545?
This trial is currently terminated. The enrollment target is 300 participants. The study started on 2015-10. Estimated completion is 2017-02-02.
Who is sponsoring clinical trial NCT02599545?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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