Preterm Birth InfantsNCT07916142
Effect of Antenatal Dexamethasone on Postnatal Adrenal Hormones in Preterm Neonates
An observational study of Preterm Birth Infants, run by Sohag University at 1 site in Egypt.
Trial summary
This study is designed to evaluate the effect of antenatal dexamethasone administration on postnatal adrenal hormone levels in preterm neonates. The research aims to assess how prenatal exposure to corticosteroids impacts the adrenal function of newborn infants during the postnatal period. Read more about this study
- Who is it for?
- Ages 0 to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth Infants
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm neonates born at Sohag University Hospital who meet the inclusion criteria.
Who may be able to join
- - Preterm neonates admitted to the neonatal intensive care unit (NICU).
- Gestational age less than 37 weeks.
Who cannot join
- - Major congenital anomalies.
- Congenital adrenal hyperplasia or endocrine disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospital
Sohag
Nancy M Atia, M.B.B.Ch, +201212295030, nancymaher714@gmail.com
About this study
This study is designed to evaluate the effect of antenatal dexamethasone administration on postnatal adrenal hormone levels in preterm neonates. The research aims to assess how prenatal exposure to corticosteroids impacts the adrenal function of newborn infants during the postnatal period.
- Conditions
- Preterm Birth Infants
- Keywords
- Dexamethasone, Adrenal Hormones
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 |
|---|---|---|
| Preterm neonates exposed to antenatal dexamethasone | Preterm infants whose mothers received antenatal dexamethasone. | |
| Control Group | Preterm infants whose mothers did not receive antenatal dexamethasone.\& full term |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postnatal Adrenal Hormone Levels
Measurement of serum cortisol and other adrenal hormone levels in preterm neonates during the postnatal period.
Measured: During the first week of life (e.g., at 24, 48, and 72 hours postnatally)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Birth InfantsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Maher Sobhy, Sohag University
- Investigators
- Atia, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916142
- Sponsor's protocol ID
- Soh-Med-26-9-15MS
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antenatal Dexamethasone on Postnatal Adrenal Hormones in Preterm Neonates
- ClinicalTrials.gov ID
- NCT07916142
- Acronym / sponsor ID
- Soh-Med-26-9-15MS
- Conditions
- Preterm Birth Infants
- Keywords
- Dexamethasone, Adrenal Hormones
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Nov 2026 (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.
This study is designed to evaluate the effect of antenatal dexamethasone administration on postnatal adrenal hormone levels in preterm neonates. The research aims to assess how prenatal exposure to corticosteroids impacts the adrenal function of newborn infants during the postnatal period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm neonates exposed to antenatal dexamethasone | – | –Preterm infants whose mothers received antenatal dexamethasone. |
| Control Group | – | –Preterm infants whose mothers did not receive antenatal dexamethasone.\& full term |
Who may qualify
- Ages
- 0 to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm neonates born at Sohag University Hospital who meet the inclusion criteria.
Key inclusion criteria (2 listed)
- - Preterm neonates admitted to the neonatal intensive care unit (NICU).
- Gestational age less than 37 weeks.
Key exclusion criteria (2 listed)
- - Major congenital anomalies.
- Congenital adrenal hyperplasia or endocrine disorders.
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
Postnatal Adrenal Hormone Levels
Time frame: During the first week of life (e.g., at 24, 48, and 72 hours postnatally)
Measurement of serum cortisol and other adrenal hormone levels in preterm neonates during the postnatal period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
Atia principal investigator
Sohag University
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 Preterm Birth Infants, run by Sohag University at 1 site in Egypt.
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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy M Atia, M.B.B.Ch, M.Sc. candidate (+201212295030, nancymaher714@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postnatal Adrenal Hormone Levels (time frame: During the first week of life (e.g., at 24, 48, and 72 hours postnatally)). 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 4 Nov 2026.