Respiratory Distress Syndrome of NewbornNCT06350565
A Clinical Pharmacological Study of Dose Halving of Dexamethasone in Pregnant Women With Preterm Labour With Preterm Birth at Greater Than or Equal to 34 Gestational Weeks (34GW+)
A study testing Dexamethasone in people with Respiratory Distress Syndrome of Newborn, run by Peking University Third Hospital.
Trial summary
This study plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Respiratory Distress Syndrome of Newborn
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Common criteria for half-dose studies and exploratory studies:
- Age 18-40 years (inclusive);
- Body mass index (BMI) 18.5-27.9 kg/m2 (inclusive).
- risk of preterm labour and use of dexamethasone for fetal lung maturation.
- Half-dose study-specific criteria:
- Greater than or equal to 34+0 gestational weeks and less than or equal to 35+6 gestational weeks at enrolment;
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- Exploratory study-specific criteria:
- Greater than or equal to 34+0 gestational weeks and less than or equal to 38+6 gestational weeks at enrolment;
- Confirmed diagnosis of GDM or having diabetes mellitus.
Who cannot join
- Multiple pregnancies (three or more pregnancies)
- For subjects who are unable to be included in this study in the following cases:
- Pregnant women with ectopic pregnancy
- Fetal distress, severe infectious (e.g. sepsis, infectious shock) disease, fever;
- Those who have taken glucocorticoid drugs within 2 weeks before joining the clinical trial;
- Those who took clindamycin during the study period;
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- Those with congenital foetal anomalies or foetal hypoxia occurring in early pregnancy;
- Patients with convulsions;
- Those with a history of HIV/HCV/hepatitis A, substance abuse;
- Chorioamnionitis, endometritis;
- Placental abruption, use of surfactant, severe intrauterine haemorrhage;
- Pregnant women with cervical dilatation greater than or equal to 4 cm or ultrasonographic neck length greater than or equal to 20 mm;
- Pregnant women taking food or drugs during the study period that may affect foetal safety;
- Pregnant women participating in other clinical trials.
- Gestational diabetes mellitus and patients with diabetes mellitus (exclusion criteria for half-dose studies only).
Trial locations and contacts
No sites are listed yet.
About this study
This study plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of dose halving in pregnant women with diabetes mellitus.
Read the detailed description
Two studies will be conducted both of which are single-centre, open clinical studies. It is proposed to collect maternal blood, umbilical vein blood and placental tissue from pregnant women treated with dexamethasone, which excludes early placental detachment, use of surfactant, severe intrauterine haemorrhage, or pregnant women who meet the conditions of the exclusion criteria. Determination and implementation of dexamethasone treatment regimen will be carried out by clinicians in accordance with the treatment guidelines, and the collection of samples will be carried out in the form of opportunistic blood sampling or placenta collection after normal diagnostic and therapeutic operations of pregnant women except for 2 active collections of blood after dosing; this study will not interfere with the normal maternal pregnancy, labour and diagnostic and therapeutic processes.
Half-dose study: A total of 24 Chinese pregnant subjects with 34+0-35+6 GW requiring dexamethasone treatment for preterm labour with preterm prematurity in China were planned to be enrolled in this study. A total of 12 subjects receiving 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the full-dose group; 12 subjects receiving 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the half-dose group.
EXPLORATORY STUDY: This study was planned to enrol 24 pregnant women with 34+0-38+6 GW preterm labour with confirmed gestational diabetes mellitus (GDM) or diabetes mellitus in combination with pregnancy in a dose exploratory study in this population. A total of 12 subjects were enrolled in the full-dose group to receive 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) and 12 subjects were enrolled in the half-dose group to receive 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses).
- Conditions
- Respiratory Distress Syndrome of Newborn
- Being tested
- Dexamethasone
- Keywords
- Dexamethasone, Pregnancy, Quantitative pharmacology
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
This clinical study will plan to enrol 24 Chinese pregnant subjects with 34+0-35+6GW preterm preterm labour requiring dexamethasone treatment and 24 pregnant women with 34+0-38+6GW preterm preterm labour and a diagnosis of gestational diabetes mellitus (GDM) or diabetes mellitus in combination with pregnancy, each of them randomly divided into 2 groups requiring 4 doses of dexamethasone intramuscularly (half-dose of 2.5 mg, normal dose of 5 mg) for two days as well as two active blood acquisitions. During the recruitment and screening phase, the purpose of the trial, the study protocol, and the trial procedure were described in detail so that the subjects were fully informed and participated voluntarily, and the compliance of the subjects in the conduct of the trial was improved.
| Study group | Role | What they receive |
|---|---|---|
| Half-dose study | Other | A total of 24 Chinese pregnant subjects with 34+0-35+6 GW requiring dexamethasone treatment for preterm labour with preterm prematurity in China were planned to be enrolled in this study. A total of 12 subjects receiving 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the full-dose group; 12 subjects receiving 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the half-dose group. Receives: Drug: Dexamethasone |
| An exploratory study | Other | This study was planned to enrol 24 pregnant women with 34+0-38+6 GW preterm labour with confirmed gestational diabetes mellitus (GDM) or diabetes mellitus in combination with pregnancy in a dose exploratory study in this population. A total of 12 subjects were enrolled in the full-dose group to receive 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) and 12 subjects were enrolled in the half-dose group to receive 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses). Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory distress syndrome
Dependent on clinical presentation, arterial blood gas analysis, and chest X-ray. (1) progressive dyspnoea, expiratory groaning, inspiratory trigonocephaly, cyanosis, and markedly reduced or absent breath sounds on lung auscultation that appeared shortly after birth; (2) lung X-ray changes typical of RDS, with diffuse fine-grained reticulated ground-glass shadows accompanied by bronchial insufflation signs; and (3) exceptions to dyspnoea caused by simple severe pneumonia, meconium aspiration or pulmonary haemorrhage, etc.
Measured: Detection and evaluation of the newborn within 24 hours of the end of delivery
PK parameters (analysed in conjunction with population pharmacokinetic (PPK) modelling): area under the blood concentration curve, Cmax, Tmax, Kel, t1/2, CL, VZ
Blood concentrations of dexamethasone and its metabolites and foetal blood concentrations
Measured: 2±0.5 h, 12 h after first dose
Pharmacodynamics
Biomarker assay and measurement of placental P-gp regulatory sensitive factor pregnancy blood concentrations.
Measured: In the course of pregnancy (GW8-delivery), the blood samples were collected every 2 weeks on average, and the blood samples were collected during each delivery and at the time of delivery, and the exact time of delivery was slightly adjusted according to
Measurability indicators
Measurable indicators: neonatal head circumference, length, weight, blood pressure (diastolic/systolic);
Measured: during labour
Blood biochemistry findings in newborns
Blood glucose concentration, blood triglyceride concentration, etc.
Measured: during labour
DEX potential safety marker test
Maternal blood and umbilical vein blood were collected at the time of delivery and concentrations of potentially toxic biomarkers (e.g. ACTH, CORT, GABA, GAD67) were measured
Measured: during labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome of NewbornStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Yangyu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350565
- Sponsor's protocol ID
- DEX20240104
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2024
- Last updated
- 16 Apr 2024
- 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacological Study of Dose Halving of Dexamethasone in Pregnant Women With Preterm Labour With Preterm Birth at Greater Than or Equal to 34 Gestational Weeks (34GW+)
- ClinicalTrials.gov ID
- NCT06350565
- Acronym / sponsor ID
- DEX20240104
- Conditions
- Respiratory Distress Syndrome of Newborn
- Keywords
- Dexamethasone, Pregnancy, Quantitative pharmacology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Apr 2024 (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 plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of dose halving in pregnant women with diabetes mellitus.
Detailed description
Two studies will be conducted both of which are single-centre, open clinical studies. It is proposed to collect maternal blood, umbilical vein blood and placental tissue from pregnant women treated with dexamethasone, which excludes early placental detachment, use of surfactant, severe intrauterine haemorrhage, or pregnant women who meet the conditions of the exclusion criteria. Determination and implementation of dexamethasone treatment regimen will be carried out by clinicians in accordance with the treatment guidelines, and the collection of samples will be carried out in the form of opportunistic blood sampling or placenta collection after normal diagnostic and therapeutic operations of pregnant women except for 2 active collections of blood after dosing; this study will not interfere with the normal maternal pregnancy, labour and diagnostic and therapeutic processes.
Half-dose study: A total of 24 Chinese pregnant subjects with 34+0-35+6 GW requiring dexamethasone treatment for preterm labour with preterm prematurity in China were planned to be enrolled in this study. A total of 12 subjects receiving 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the full-dose group; 12 subjects receiving 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the half-dose group.
EXPLORATORY STUDY: This study was planned to enrol 24 pregnant women with 34+0-38+6 GW preterm labour with confirmed gestational diabetes mellitus (GDM) or diabetes mellitus in combination with pregnancy in a dose exploratory study in this population. A total of 12 subjects were enrolled in the full-dose group to receive 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) and 12 subjects were enrolled in the half-dose group to receive 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Half-dose study | Other | Drug: DexamethasoneA total of 24 Chinese pregnant subjects with 34+0-35+6 GW requiring dexamethasone treatment for preterm labour with preterm prematurity in China were planned to be enrolled in this study. A total of 12 subjects receiving 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the full-dose group; 12 subjects receiving 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the half-dose group. |
| An exploratory study | Other | Drug: DexamethasoneThis study was planned to enrol 24 pregnant women with 34+0-38+6 GW preterm labour with confirmed gestational diabetes mellitus (GDM) or diabetes mellitus in combination with pregnancy in a dose exploratory study in this population. A total of 12 subjects were enrolled in the full-dose group to receive 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) and 12 subjects were enrolled in the half-dose group to receive 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-40 years (inclusive);
- Body mass index (BMI) 18.5-27.9 kg/m2 (inclusive).
- risk of preterm labour and use of dexamethasone for fetal lung maturation.
- Greater than or equal to 34+0 gestational weeks and less than or equal to 35+6 gestational weeks at enrolment;
- Greater than or equal to 34+0 gestational weeks and less than or equal to 38+6 gestational weeks at enrolment;
Key exclusion criteria (15 listed)
- Multiple pregnancies (three or more pregnancies)
- For subjects who are unable to be included in this study in the following cases:
- Pregnant women with ectopic pregnancy
- Fetal distress, severe infectious (e.g. sepsis, infectious shock) disease, fever;
- Those who have taken glucocorticoid drugs within 2 weeks before joining the clinical trial;
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 |
|---|---|---|
| DexamethasoneThis clinical study will plan to enrol 24 Chinese pregnant subjects with 34+0-35+6GW preterm preterm labour requiring dexamethasone treatment and 24 pregnant women with 34+0-38+6GW preterm preterm labour and a diagnosis of gestational diabetes mellitus (GDM) or diabetes mellitus in combination with pregnancy, each of them randomly divided into 2 groups requiring 4 doses of dexamethasone intramuscularly (half-dose of 2.5 mg, normal dose of 5 mg) for two days as well as two active blood acquisitions. During the recruitment and screening phase, the purpose of the trial, the study protocol, and the trial procedure were described in detail so that the subjects were fully informed and participated voluntarily, and the compliance of the subjects in the conduct of the trial was improved. | Drug | An exploratory study, Half-dose study |
Primary outcome
Respiratory distress syndrome
Time frame: Detection and evaluation of the newborn within 24 hours of the end of delivery
Dependent on clinical presentation, arterial blood gas analysis, and chest X-ray. (1) progressive dyspnoea, expiratory groaning, inspiratory trigonocephaly, cyanosis, and markedly reduced or absent breath sounds on lung auscultation that appeared shortly after birth; (2) lung X-ray changes typical of RDS, with diffuse fine-grained reticulated ground-glass shadows accompanied by bronchial insufflation signs; and (3) exceptions to dyspnoea caused by simple severe pneumonia, meconium aspiration or pulmonary haemorrhage, etc.
PK parameters (analysed in conjunction with population pharmacokinetic (PPK) modelling): area under the blood concentration curve, Cmax, Tmax, Kel, t1/2, CL, VZ
Time frame: 2±0.5 h, 12 h after first dose
Blood concentrations of dexamethasone and its metabolites and foetal blood concentrations
Pharmacodynamics
Time frame: In the course of pregnancy (GW8-delivery), the blood samples were collected every 2 weeks on average, and the blood samples were collected during each delivery and at the time of delivery, and the exact time of delivery was slightly adjusted according to
Biomarker assay and measurement of placental P-gp regulatory sensitive factor pregnancy blood concentrations.
Measurability indicators
Time frame: during labour
Measurable indicators: neonatal head circumference, length, weight, blood pressure (diastolic/systolic);
Blood biochemistry findings in newborns
Time frame: during labour
Blood glucose concentration, blood triglyceride concentration, etc.
DEX potential safety marker test
Time frame: during labour
Maternal blood and umbilical vein blood were collected at the time of delivery and concentrations of potentially toxic biomarkers (e.g. ACTH, CORT, GABA, GAD67) were measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Respiratory Distress Syndrome of Newborn, run by Peking University Third Hospital.
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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongyang Liu (18610966092, liudongyang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory distress syndrome (time frame: Detection and evaluation of the newborn within 24 hours of the end of delivery). The study lists 6 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 16 Apr 2024.