Clinical Trials Logo
  1. Home
  2. Infant, Premature
  3. NCT02599545

Testosterone and Cortisol Levels in Infants

Infant, Premature Clinical Trial

Official title:
Testosterone and Cortisol Levels in Infant Health and Development

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02599545
Study type Observational
Source Duke University
Contact
Status Terminated
Phase
Start date October 2015
Completion date February 2, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT03146351 - The Effects of Family Centered Intervention Program on Preterm Infants N/A
Completed NCT02064712 - Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates N/A
Completed NCT00365703 - Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best? N/A
Terminated NCT00179933 - The Impact of Implementing NIDCAP on Preterm Infants in the NICU N/A
Completed NCT00114543 - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight Phase 3
Terminated NCT05030012 - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants N/A
Completed NCT00552383 - The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care N/A
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Completed NCT06308471 - Effect of Baby Massage on Oral Motor Skills of Premature Babies N/A
Completed NCT01863043 - Aspiration of Residual Gastric Contents N/A
Completed NCT05462509 - Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda N/A
Not yet recruiting NCT06109350 - The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed NCT02611284 - Less Invasive Beractant Administration in Preterm Infants N/A
Completed NCT01193270 - Vitamin E for Extremely Preterm Infants Phase 1
Withdrawn NCT00536445 - Use of NAVA in Intubated Preterm Phase 1/Phase 2
Completed NCT00455169 - Influenza Vaccine in Premature Infants Phase 4
Completed NCT00579553 - Comparing IM vs. Vaginal Progesterone for Pre-term Birth N/A
Completed NCT01203423 - Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
Active, not recruiting NCT02863978 - Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database N/A