Cortisol OverproductionNCT03830437
Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Physiological Body Weight
An observational study of Cortisol Overproduction, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
Trial summary
According to scientific revisions, salivary cortisol is a valid method for measuring adrenocortical activity in newborns because it is non-invasive in fact the measurement of salivary cortisol has been used as a stress marker in newborns since 1992. Read more about this study
- Who is it for?
- Ages 37 to 42 weeks
- Conditions the study is for
- Cortisol Overproduction
- What is being tested?
- Evaluation of newborn stress and Evaluation of body weight trend
- Type of treatment
- Pill or oral medicine
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 21 Sep 2018to 1 Jun 2019
- 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 37 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Caucasian newborns with 37-42 weeks of gestational age and that live in Lombardia.
Who may be able to join
- Gestational age: 37-42 wks
- Body Weight: >2500 g
- Body weight loss >3±1,5% at 24 hr from birth
- First-born
- Eutocic delivery
- Mother BMI:19-24
- Glycaemia >50 mg/dl
Who cannot join
- Mother disease
- Admission in NICU
- Neonatal pathologies
- Utilization of human milk
- Body weight loss > 10%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Body Weight Loss of 3±1,5% at 24 hr From Birth
According to scientific revisions, salivary cortisol is a valid method for measuring adrenocortical activity in newborns because it is non-invasive in fact the measurement of salivary cortisol has been used as a stress marker in newborns since 1992. The mechanism by which cortisol induces stress, concerns the hypothalamic-pituitary-adrenal axis. The hypothalamus produces the corticotropin-releasing hormone, which stimulates the production of adrenocorticotropin by hypophysis. Adrenocorticotropin induces the secretion of glucocorticoids such as cortisol by stimulating the cortex of the adrenal gland. An appropriate release of cortisol due to stress factor is vital for surviving and the loss of this mechanism increase the risk of morbidity and mortality for newborns. However, prolonged exposure to a high level of cortisol may increase the risk of cognitive and behavioural disorders, hypertension, hyperlipidaemia, insulin resistance, immune deficiency and hippocampal impairment. The separation from the mother, the exposure to painful procedures but also routine interventions such as physical examination, diaper changes and bathing increase the salivary cortisol level of the newborn compared to the basal state. The measurement of salivary cortisol in the newborn therefore has the aim of understanding and preventing those stressful conditions that may have long-term side effects. For this reason, the lose weight in the first days and double weighing should be a stress practice for the newborn.
Read the detailed description
After the phase of early adaptation, newborn must learn quickly to live out of the mother uterus. In this phase of life, physiological mechanisms are activated. Newborn loss body weight because loss liquid by respiration, feces, urine and not adequate feeding. Body weight loss after birth is physiological when is lower than 10% but is also important the evaluation of body weight daily trend that must be lower than 5%. If newborn shows physiological body weight loss, no treatment will be necessary and rooming-in can continue together with exclusively breastfeeding.
Furthermore, if newborn lose more than 10% of body weight during 48hr of life or more than 5% of body weight in a day, a dehydration state will occur that will influence negatively the physiological cardio-circulatory and kidney adaptation. In these cases, is important execute controls and a specific therapy. When body weight loss is between 7%-10%, usually in Neonatology wards it is used double weighing before and after breastfeeding. This practice evaluates colostrum quantity that is assumed from infant during feeding and the necessity of milk formula integration to prevent an excessive body weight loss. Diuresis is also monitored, and parents are informed on the benefits of breastfeeding.
If body weight loss is greater than 10%, diuresis is monitored weighing the diaper and haematological examinations are performed. In this case, it is counselled an artificial milk integration after breastfeeding. Discharge can be influenced from the results of the controls and must be executed for the security of the newborn.
Health care providers must not be underestimated the possible allergies to formula milk and the mothers that give up breastfeeding after the use of formula milk. The newborn should receive breastfeeding from the delivery room. It is good practice, when the milk secretion is enough, to attach the infant to a single breast for each feeding and let it suck for 15-20 minutes. Quantity of milk that newborn assume for each feeding is object of careful evaluation. Double weighing consists in weighing newborn before and after feeding: the body weight difference is the quantity of milk assumed. In the first day of life, newborn should suck 10 gr of colostrum or milk for each feeding. Then starting from the second day of life, the quantity of milk assumed must be increased of 10 gr/die for the first week.
According to scientific revisions, salivary cortisol is a valid method for measuring adrenocortical activity in newborns because it is non-invasive in fact the measurement of salivary cortisol has been used as a stress marker in newborns since 1992. The mechanism by which cortisol induces stress, concerns the hypothalamic-pituitary-adrenal axis. The hypothalamus produces the corticotropin-releasing hormone, which stimulates the production of adrenocorticotropin by hypophysis. Adrenocorticotropin induces the secretion of glucocorticoids such as cortisol by stimulating the cortex of the adrenal gland. An appropriate release of cortisol due to stress factor is vital for surviving and the loss of this mechanism increase the risk of morbidity and mortality for newborns. However, prolonged exposure to a high level of cortisol may increase the risk of cognitive and behavioural disorders, hypertension, hyperlipidaemia, insulin resistance, immune deficiency and hippocampal impairment. The separation from the mother, the exposure to painful procedures but also routine interventions such as physical examination, diaper changes and bathing increase the salivary cortisol level of the newborn compared to the basal state. The measurement of salivary cortisol in the newborn therefore has the aim of understanding and preventing those stressful conditions that may have long-term side effects. For this reason, the lose weight in the first days and double weighing should be a stress practice for the newborn.
- Conditions
- Cortisol Overproduction
- Being tested
- Evaluation of newborn stress, Evaluation of body weight trend
- Keywords
- Newborn, Salivary Cortisol Level, Double Weghing, Physiological weight loss, Breastfeeding, Stress marker
- Medical subject headings
- ACTH Syndrome, Ectopic, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of newborn stressOther
Newborn stress will be evaluated by salivary cortisol levels at 48 hr of life. Saliva sample of the newborns will be collected in oral cavity at 48 hr of life. Samples collected will be storage at -80 C for up to 4 months and analysed by analysis laboratory of Poliambulanza Foundation.
Evaluation of body weight trendOther
Body weight trend between newborns subjected to double weighing or to body weight control will be carried out at 36 hr and 48 hr of life
| Study group | Role | What they receive |
|---|---|---|
| Case group | The group will be subjected to double weighing, before and after the next 6 breastfeeding. Breastfeeding will be carried out each 4 hr. Receives: Other: Evaluation of newborn stress; Other: Evaluation of body weight trend | |
| Control group | The group will be subjected to monitoring of body weight only at 24, 36 hr and 48 hr of life. Receives: Other: Evaluation of newborn stress; Other: Evaluation of body weight trend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of salivary cortisol levels
Evaluation of salivary cortisol level as stress marker in newborns with body weight loss of 3±1,5% at 24 hours from birth subjected to double weighing or to body weight control at 36 hours and 48 hours of life.
Measured: 48 hours
Secondary outcomes (1)
Evaluation of body weight trend
Evaluation of body weight trend between newborns subjected to double weighing or to body weight control at 36 hours and 48 hours of life.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start21 Sep 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cortisol OverproductionStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe De Bernando, Fondazione Poliambulanza Istituto Ospedaliero
- Investigators
- Giuseppe De Bernardo, M.D., Principal investigator, Fondazione Poliambulanza Istituto OspedalieroLaura Linetti, Dott., Study director, Fondazione Poliambulanza Istituto Ospedaliero
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830437
- Sponsor's protocol ID
- 3175
- Status last verified
- Jul 2019
- First submitted
- 1 Feb 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janet M. Rennie, "Textbook of Neonatology" Elsevier Health Sciences, London, 2012
Horta, B.L.; Victora, C.G. Long-Term Effects of Breastfeeding: A Systematic Review; World Health Organization: Geneva, Switzerland, 2013, pp. 1-68
Rodriguez G, Ventura P, Samper MP, Moreno L, Sarria A, Perez-Gonzalez JM. Changes in body composition during the initial hours of life in breast-fed healthy term newborns. Biol Neonate. 2000;77(1):12-6. doi: 10.1159/000014189.
PubMed 10658825Thulier D. Weighing the Facts: A Systematic Review of Expected Patterns of Weight Loss in Full-Term, Breastfed Infants. J Hum Lact. 2016 Feb;32(1):28-34. doi: 10.1177/0890334415597681. Epub 2015 Aug 7.
PubMed 26253288Noel-Weiss J, Courant G, Woodend AK. Physiological weight loss in the breastfed neonate: a systematic review. Open Med. 2008;2(4):e99-e110. Epub 2008 Oct 28.
PubMed 21602959Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
PubMed 26869575Flaherman VJ, Kuzniewicz MW, Li S, Walsh E, McCulloch CE, Newman TB. First-day weight loss predicts eventual weight nadir for breastfeeding newborns. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F488-92. doi: 10.1136/archdischild-2012-303076. Epub 2013 Jul 17.
PubMed 23864443Bertini G, Breschi R, Dani C. Physiological weight loss chart helps to identify high-risk infants who need breastfeeding support. Acta Paediatr. 2015 Oct;104(10):1024-7. doi: 10.1111/apa.12820. Epub 2014 Oct 22.
PubMed 25283590Ferrandez-Gonzalez M, Bosch-Gimenez V, Lopez-Lozano J, Moreno-Lopez N, Palazon-Bru A, Cortes-Castell E. Weight loss thresholds to detect early hypernatremia in newborns. J Pediatr (Rio J). 2019 Nov-Dec;95(6):689-695. doi: 10.1016/j.jped.2018.06.005. Epub 2018 Jul 18.
PubMed 30030986Righard L, Alade MO. Effect of delivery room routines on success of first breast-feed. Lancet. 1990 Nov 3;336(8723):1105-7. doi: 10.1016/0140-6736(90)92579-7.
PubMed 1977988Jang GJ, Kim SH, Jeong KS. [Effect of postpartum breast-feeding support by nurse on the breast-feeding prevalence]. Taehan Kanho Hakhoe Chi. 2008 Feb;38(1):172-9. doi: 10.4040/jkan.2008.38.1.172. Korean.
PubMed 18323730Woolridge MW, Baum JD, Drewett RF. Individual patterns of milk intake during breast-feeding. Early Hum Dev. 1982 Dec 6;7(3):265-72. doi: 10.1016/0378-3782(82)90089-5.
PubMed 7160336Cignacco E, Denhaerynck K, Nelle M, Buhrer C, Engberg S. Variability in pain response to a non-pharmacological intervention across repeated routine pain exposure in preterm infants: a feasibility study. Acta Paediatr. 2009 May;98(5):842-6. doi: 10.1111/j.1651-2227.2008.01203.x. Epub 2009 Jan 13.
PubMed 19183121De Bernardo G, Riccitelli M, Giordano M, Proietti F, Sordino D, Longini M, Buonocore G, Perrone S. Rooming-in Reduces Salivary Cortisol Level of Newborn. Mediators Inflamm. 2018 Mar 8;2018:2845352. doi: 10.1155/2018/2845352. eCollection 2018.
PubMed 29706798Levine S. Developmental determinants of sensitivity and resistance to stress. Psychoneuroendocrinology. 2005 Nov;30(10):939-46. doi: 10.1016/j.psyneuen.2005.03.013.
PubMed 15958281
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Body Weight Loss of 3±1,5% at 24 hr From Birth
- ClinicalTrials.gov ID
- NCT03830437
- Acronym / sponsor ID
- 3175
- Conditions
- Cortisol Overproduction
- Keywords
- Newborn, Salivary Cortisol Level, Double Weghing, Physiological weight loss, Breastfeeding, Stress marker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 5 Feb 2019 (actual)
- 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.
According to scientific revisions, salivary cortisol is a valid method for measuring adrenocortical activity in newborns because it is non-invasive in fact the measurement of salivary cortisol has been used as a stress marker in newborns since 1992. The mechanism by which cortisol induces stress, concerns the hypothalamic-pituitary-adrenal axis. The hypothalamus produces the corticotropin-releasing hormone, which stimulates the production of adrenocorticotropin by hypophysis. Adrenocorticotropin induces the secretion of glucocorticoids such as cortisol by stimulating the cortex of the adrenal gland. An appropriate release of cortisol due to stress factor is vital for surviving and the loss of this mechanism increase the risk of morbidity and mortality for newborns. However, prolonged exposure to a high level of cortisol may increase the risk of cognitive and behavioural disorders, hypertension, hyperlipidaemia, insulin resistance, immune deficiency and hippocampal impairment. The separation from the mother, the exposure to painful procedures but also routine interventions such as physical examination, diaper changes and bathing increase the salivary cortisol level of the newborn compared to the basal state. The measurement of salivary cortisol in the newborn therefore has the aim of understanding and preventing those stressful conditions that may have long-term side effects. For this reason, the lose weight in the first days and double weighing should be a stress practice for the newborn.
Detailed description
After the phase of early adaptation, newborn must learn quickly to live out of the mother uterus. In this phase of life, physiological mechanisms are activated. Newborn loss body weight because loss liquid by respiration, feces, urine and not adequate feeding. Body weight loss after birth is physiological when is lower than 10% but is also important the evaluation of body weight daily trend that must be lower than 5%. If newborn shows physiological body weight loss, no treatment will be necessary and rooming-in can continue together with exclusively breastfeeding.
Furthermore, if newborn lose more than 10% of body weight during 48hr of life or more than 5% of body weight in a day, a dehydration state will occur that will influence negatively the physiological cardio-circulatory and kidney adaptation. In these cases, is important execute controls and a specific therapy. When body weight loss is between 7%-10%, usually in Neonatology wards it is used double weighing before and after breastfeeding. This practice evaluates colostrum quantity that is assumed from infant during feeding and the necessity of milk formula integration to prevent an excessive body weight loss. Diuresis is also monitored, and parents are informed on the benefits of breastfeeding.
If body weight loss is greater than 10%, diuresis is monitored weighing the diaper and haematological examinations are performed. In this case, it is counselled an artificial milk integration after breastfeeding. Discharge can be influenced from the results of the controls and must be executed for the security of the newborn.
Health care providers must not be underestimated the possible allergies to formula milk and the mothers that give up breastfeeding after the use of formula milk. The newborn should receive breastfeeding from the delivery room. It is good practice, when the milk secretion is enough, to attach the infant to a single breast for each feeding and let it suck for 15-20 minutes. Quantity of milk that newborn assume for each feeding is object of careful evaluation. Double weighing consists in weighing newborn before and after feeding: the body weight difference is the quantity of milk assumed. In the first day of life, newborn should suck 10 gr of colostrum or milk for each feeding. Then starting from the second day of life, the quantity of milk assumed must be increased of 10 gr/die for the first week.
According to scientific revisions, salivary cortisol is a valid method for measuring adrenocortical activity in newborns because it is non-invasive in fact the measurement of salivary cortisol has been used as a stress marker in newborns since 1992. The mechanism by which cortisol induces stress, concerns the hypothalamic-pituitary-adrenal axis. The hypothalamus produces the corticotropin-releasing hormone, which stimulates the production of adrenocorticotropin by hypophysis. Adrenocorticotropin induces the secretion of glucocorticoids such as cortisol by stimulating the cortex of the adrenal gland. An appropriate release of cortisol due to stress factor is vital for surviving and the loss of this mechanism increase the risk of morbidity and mortality for newborns. However, prolonged exposure to a high level of cortisol may increase the risk of cognitive and behavioural disorders, hypertension, hyperlipidaemia, insulin resistance, immune deficiency and hippocampal impairment. The separation from the mother, the exposure to painful procedures but also routine interventions such as physical examination, diaper changes and bathing increase the salivary cortisol level of the newborn compared to the basal state. The measurement of salivary cortisol in the newborn therefore has the aim of understanding and preventing those stressful conditions that may have long-term side effects. For this reason, the lose weight in the first days and double weighing should be a stress practice for the newborn.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Evaluation of newborn stress, Other: Evaluation of body weight trendThe group will be subjected to double weighing, before and after the next 6 breastfeeding. Breastfeeding will be carried out each 4 hr. |
| Control group | – | Other: Evaluation of newborn stress, Other: Evaluation of body weight trendThe group will be subjected to monitoring of body weight only at 24, 36 hr and 48 hr of life. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Caucasian newborns with 37-42 weeks of gestational age and that live in Lombardia.
Key inclusion criteria (7 listed)
- Gestational age: 37-42 wks
- Body Weight: >2500 g
- Body weight loss >3±1,5% at 24 hr from birth
- First-born
- Eutocic delivery
Key exclusion criteria (5 listed)
- Mother disease
- Admission in NICU
- Neonatal pathologies
- Utilization of human milk
- Body weight loss > 10%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of newborn stressNewborn stress will be evaluated by salivary cortisol levels at 48 hr of life. Saliva sample of the newborns will be collected in oral cavity at 48 hr of life. Samples collected will be storage at -80 C for up to 4 months and analysed by analysis laboratory of Poliambulanza Foundation. | Other | Case group, Control group |
| Evaluation of body weight trendBody weight trend between newborns subjected to double weighing or to body weight control will be carried out at 36 hr and 48 hr of life | Other | Case group, Control group |
Primary outcome
Evaluation of salivary cortisol levels
Time frame: 48 hours
Evaluation of salivary cortisol level as stress marker in newborns with body weight loss of 3±1,5% at 24 hours from birth subjected to double weighing or to body weight control at 36 hours and 48 hours of life.
1 secondary outcome
Evaluation of body weight trend
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- BackgroundJanet M. Rennie, "Textbook of Neonatology" Elsevier Health Sciences, London, 2012
- BackgroundHorta, B.L.; Victora, C.G. Long-Term Effects of Breastfeeding: A Systematic Review; World Health Organization: Geneva, Switzerland, 2013, pp. 1-68
- Results publication: PubMed 10658825Rodriguez G, Ventura P, Samper MP, Moreno L, Sarria A, Perez-Gonzalez JM. Changes in body composition during the initial hours of life in breast-fed healthy term newborns. Biol Neonate. 2000;77(1):12-6. doi: 10.1159/000014189.
- Results publication: PubMed 26253288Thulier D. Weighing the Facts: A Systematic Review of Expected Patterns of Weight Loss in Full-Term, Breastfed Infants. J Hum Lact. 2016 Feb;32(1):28-34. doi: 10.1177/0890334415597681. Epub 2015 Aug 7.
- Results publication: PubMed 21602959Noel-Weiss J, Courant G, Woodend AK. Physiological weight loss in the breastfed neonate: a systematic review. Open Med. 2008;2(4):e99-e110. Epub 2008 Oct 28.
- Results publication: PubMed 26869575Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
- Results publication: PubMed 23864443Flaherman VJ, Kuzniewicz MW, Li S, Walsh E, McCulloch CE, Newman TB. First-day weight loss predicts eventual weight nadir for breastfeeding newborns. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F488-92. doi: 10.1136/archdischild-2012-303076. Epub 2013 Jul 17.
- Results publication: PubMed 25283590Bertini G, Breschi R, Dani C. Physiological weight loss chart helps to identify high-risk infants who need breastfeeding support. Acta Paediatr. 2015 Oct;104(10):1024-7. doi: 10.1111/apa.12820. Epub 2014 Oct 22.
- Results publication: PubMed 30030986Ferrandez-Gonzalez M, Bosch-Gimenez V, Lopez-Lozano J, Moreno-Lopez N, Palazon-Bru A, Cortes-Castell E. Weight loss thresholds to detect early hypernatremia in newborns. J Pediatr (Rio J). 2019 Nov-Dec;95(6):689-695. doi: 10.1016/j.jped.2018.06.005. Epub 2018 Jul 18.
- Results publication: PubMed 1977988Righard L, Alade MO. Effect of delivery room routines on success of first breast-feed. Lancet. 1990 Nov 3;336(8723):1105-7. doi: 10.1016/0140-6736(90)92579-7.
- Results publication: PubMed 18323730Jang GJ, Kim SH, Jeong KS. [Effect of postpartum breast-feeding support by nurse on the breast-feeding prevalence]. Taehan Kanho Hakhoe Chi. 2008 Feb;38(1):172-9. doi: 10.4040/jkan.2008.38.1.172. Korean.
- Results publication: PubMed 7160336Woolridge MW, Baum JD, Drewett RF. Individual patterns of milk intake during breast-feeding. Early Hum Dev. 1982 Dec 6;7(3):265-72. doi: 10.1016/0378-3782(82)90089-5.
- Individual participant dataSharing planned: No
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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.
Giuseppe De Bernardo, M.D. principal investigator
Fondazione Poliambulanza Istituto Ospedaliero
Laura Linetti, Dott. study director
Fondazione Poliambulanza Istituto Ospedaliero
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 Cortisol Overproduction, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jul 2019. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of salivary cortisol levels (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830437, which also lists 17 linked publications.
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 30 Jul 2019.