Infant, PrematureNCT02599545
Testosterone and Cortisol Levels in Infants
An observational study of Infant, Premature and Infant, Very Low Birth Weight, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 72 hours
- Conditions the study is for
- Infant, Premature, Infant, Very Low Birth Weight
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 2 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 72 hours
- All sexes
- No healthy volunteers
- Child
Study population: Mothers will be eligible for consent if they are a patient in the Duke University Hospital Labor \& Delivery department and meet all eligibility criteria. Potential mothers will be approached about the study before delivery or within 72 hours after delivery. 150 mother-VLBW infant pairs, a total of 300 participants, will be recruited for the final sample size of 120 pairs. English or Spanish speaking mothers may participate. If the mother is between 15-17 years of age, a minor mother consent will be used. If the mother is Spanish speaking, a Spanish short form consent will be used with a Spanish interpreter. If the mother is pre-consented, the infant may or may not be enrolled at delivery. The infant could be excluded if he/she is delivered at a gestation or weight that is outside of study limits, or if she/he has a severe health problem/congenital anomaly detected at birth.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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).
- Conditions
- Infant, Premature, Infant, Very Low Birth Weight
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Maternal/VLBW Infant Pairs | One-hundred-fifty mother-VLBW infant pairs, a total of 300 participants, will be recruited for the final sample size of 120 pairs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurements of maternal and neonate/infant testosterone and cortisol (T&C) levels from admission through 24-months of life to determine associations of T&C with health outcomes of neonates and infants between genders
The levels of testosterone and cortisol will be measured and compared with health outcomes of neonates/infants, at birth, 40 weeks postmenstrual age (PMA), 6, 12, and 24 months corrected age (CA) after controlling for covariates. The latter include maternal psychological state, infant temperament, and characteristics of mothers (age, race, body mass index [BMI], education, and marital status).
Measured: Admission through 24 months of life
video recorded interactions at 12- and 24-months to determine associations of testosterone and cortisol levels with quality of mother-infant interactions between genders during infancy
The levels of testosterone and cortisol will be measured and compared with quality of mother-infant interactions at 12- and 24-months CA after controlling for the covariates.
Measured: 12- and 24-months of age
standard infant testing at 12- and 24-months of age to determine associations of testosterone and cortisol levels with infant cognitive/motor/language development between genders during infancy
The levels of testosterone and cortisol will be measured and compared with infant development at 12- and 24-months CA after controlling for the covariates and mother-infant interactions.
Measured: 12- and 24-months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startOct 2015
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Dr. June Cho, PhD, RN, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599545
- Sponsor's protocol ID
- Pro00065480
- Status last verified
- Jul 2017
- First submitted
- 29 Oct 2015
- Last updated
- 12 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone and Cortisol Levels in Infant Health and Development
- ClinicalTrials.gov ID
- NCT02599545
- Acronym / sponsor ID
- Pro00065480
- Conditions
- Infant, Premature, Infant, Very Low Birth Weight
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 2015
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maternal/VLBW Infant Pairs | – | –One-hundred-fifty mother-VLBW infant pairs, a total of 300 participants, will be recruited for the final sample size of 120 pairs. |
Who may qualify
- Ages
- 1 minute to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Mothers will be eligible for consent if they are a patient in the Duke University Hospital Labor \& Delivery department and meet all eligibility criteria. Potential mothers will be approached about the study before delivery or within 72 hours after delivery. 150 mother-VLBW infant pairs, a total of 300 participants, will be recruited for the final sample size of 120 pairs. English or Spanish speaking mothers may participate. If the mother is between 15-17 years of age, a minor mother consent will be used. If the mother is Spanish speaking, a Spanish short form consent will be used with a Spanish interpreter. If the mother is pre-consented, the infant may or may not be enrolled at delivery. The infant could be excluded if he/she is delivered at a gestation or weight that is outside of study limits, or if she/he has a severe health problem/congenital anomaly detected at birth.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measurements of maternal and neonate/infant testosterone and cortisol (T&C) levels from admission through 24-months of life to determine associations of T&C with health outcomes of neonates and infants between genders
Time frame: Admission through 24 months of life
The levels of testosterone and cortisol will be measured and compared with health outcomes of neonates/infants, at birth, 40 weeks postmenstrual age (PMA), 6, 12, and 24 months corrected age (CA) after controlling for covariates. The latter include maternal psychological state, infant temperament, and characteristics of mothers (age, race, body mass index [BMI], education, and marital status).
video recorded interactions at 12- and 24-months to determine associations of testosterone and cortisol levels with quality of mother-infant interactions between genders during infancy
Time frame: 12- and 24-months of age
The levels of testosterone and cortisol will be measured and compared with quality of mother-infant interactions at 12- and 24-months CA after controlling for the covariates.
standard infant testing at 12- and 24-months of age to determine associations of testosterone and cortisol levels with infant cognitive/motor/language development between genders during infancy
Time frame: 12- and 24-months of age
The levels of testosterone and cortisol will be measured and compared with infant development at 12- and 24-months CA after controlling for the covariates and mother-infant interactions.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
Related trials for Infant, Premature
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. June Cho, PhD, RN principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature and Infant, Very Low Birth Weight, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurements of maternal and neonate/infant testosterone and cortisol (T&C) levels from admission through 24-months of life to determine associations of T&C with health outcomes of neonates and infants between genders (time frame: Admission through 24 months of life). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.