Hyaline Membrane Disease (HMD)CORISURFNCT05455879
Impact of Antenatal Corticosteroid Therapy on Postnatal Surfactant Use in Preterm Infants
An observational study of Hyaline Membrane Disease (HMD), run by Hôpital NOVO at 1 site in France.
Trial summary
No study has shown that two doses of corticosteroids are more effective than a single dose in lung maturation and prevention of hyaline membrane disease (HMD) The aim of this study is to assess the impact of the number of doses on the severity of HMD. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Hyaline Membrane Disease (HMD)
- What is being tested?
- Impact of antenatal corticosteroid therapy on surfactants use postnatal
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2022to 5 Jul 2022
- 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 Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants (≤ 37 SA), hospitalized in the neonatal intensive care unit between January 2018 and December 2019 and having received at least one dose of corticosteroids antenatal
Who may be able to join
- Preterm infants ≤ 37 SA
- Hospitalized in the neonatal intensive care unit between January 2018 and December 2019
- Having received at least one dose of corticosteroids antenatal
Who cannot join
- Parental Opposition
- Congenital malformations that may cause neonatal respiratory distress.
Trial locations and contacts
1 site in 1 country.
France1 site
Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos
Pontoise
About this study
Official title: Impact of the Number of Doses of Antenatal Corticosteroid Therapy on the Number of Doses of Surfactants Postnatal in Preterm Infants
No study has shown that two doses of corticosteroids are more effective than a single dose in lung maturation and prevention of hyaline membrane disease (HMD) The aim of this study is to assess the impact of the number of doses on the severity of HMD.
Read the detailed description
Respiratory distress syndrome (RDS), formerly known as hyaline membrane disease, is a common problem in preterm infants. This disorder is caused primarily by deficiency of pulmonary surfactant in an immature lung. RDS is a major cause of morbidity and mortality in preterm infants.
Surfactant therapy has been shown to significantly reduce neonatal and infant mortality. Corticosteroids are given antenatal, and then surfactant is given, along with corticosteroids, postnatal.
A single course of corticosteroids is recommended for pregnant women between 24 weeks and 34 weeks of gestation who are at risk of preterm delivery within 7 days, including those with ruptured membranes and multiple pregnancies.
Betamethasone is recommended as the steroid of choice, to be administered in two doses of 12 mg given intramuscularly 24 hours apart.
- Conditions
- Hyaline Membrane Disease (HMD)
- Being tested
- Impact of antenatal corticosteroid therapy on surfactants use postnatal
- Keywords
- Corticosteroid therapy, Surfactants, Preterm infants
- Medical subject headings
- Hyaline Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of antenatal corticosteroid therapy on surfactants use postnatalOther
Intervention Description: Retrospective study on preterm infants to evaluate the impact of antenatal corticosteroid therapy on surfactants use postnatal
| Study group | Role | What they receive |
|---|---|---|
| Impact of antenatal corticosteroid therapy on surfactants use postnatal | Intervention Description: Retrospective study on preterm infants to evaluate the impact of antenatal corticosteroid therapy on surfactants use postnatal Receives: Other: Impact of antenatal corticosteroid therapy on surfactants use postnatal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the effect of a full course of antenatal corticosteroid therapy versus a half course on the number of postnatal surfactant doses in preterm infants.
Comparison of the number of doses of surfactants administered postnatal in preterm infants who received 2 doses of antenatal corticosteroid therapy versus those who received a single dose
Measured: At the end of the study, an average of 2 month
Secondary outcomes (5)
Assessment of the influence of gestational age on the severity of hyaline membrane disease (HMD)
Radiological stage of HMD according to gestational age :
Stage 1 : reticulo-granular appearance / borderline normal imaging of the lung, Stage 2 : diffuse reticulo-granular appearance / Visible mediastinal borders Stage 3 : global decrease in lung transparency / Bronchogram aerial / Blurred mediastinal borders Stage 4 : white lungs
Measured: At the end of the study, an average of 2 month
Assessment of the influence of the cause of prematurity on the severity of hyaline membrane disease (HMD)
Radiological stage of HMD according to cause of prematurity :
Stage 1 : reticulo-granular appearance / borderline normal imaging of the lung, Stage 2 : diffuse reticulo-granular appearance / Visible mediastinal borders Stage 3 : global decrease in lung transparency / Bronchogram aerial / Blurred mediastinal borders Stage 4 : white lungs
Measured: At the end of the study, an average of 2 month
Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the use of postnatal corticosteroid therapy
Prevalence of postnatal corticosteroid therapy by number of doses of antenatal corticosteroid therapy
Measured: At the end of the study, an average of 2 month
Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the prevalence of bronchopulmonary dysplasia
Prevalence of bronchopulmonary dysplasia as a function of the number of doses of antenatal corticosteroid therapy
Measured: At the end of the study, an average of 2 month
Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the severity of intraventricular hemorrhage
Stage of intraventricular hemorrhage on transfontanellar ultrasound (FET) according to the number of doses of antenatal corticosteroid therapy :
Stage 1 : Germline or subependymal hemorrhage (SEH), Stage 2 : Ventricular hemorrhage Stage 3 : Ventriculomegaly (VM) Stage 4 : Hemorrhage in the brain parenchyma
Measured: At the end of the study, an average of 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start20 Jun 2022
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyaline Membrane Disease (HMD)Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Suzanne BORRHOMEE, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455879
- Sponsor's protocol ID
- CHRD0822
- Acronym
- CORISURF
- Status last verified
- Oct 2022
- First submitted
- 8 Jul 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Number of Doses of Antenatal Corticosteroid Therapy on the Number of Doses of Surfactants Postnatal in Preterm Infants
- ClinicalTrials.gov ID
- NCT05455879
- Acronym / sponsor ID
- CORISURF / CHRD0822
- Conditions
- Hyaline Membrane Disease (HMD)
- Keywords
- Corticosteroid therapy, Surfactants, Preterm infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 13 Jul 2022 (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.
No study has shown that two doses of corticosteroids are more effective than a single dose in lung maturation and prevention of hyaline membrane disease (HMD) The aim of this study is to assess the impact of the number of doses on the severity of HMD.
Detailed description
Respiratory distress syndrome (RDS), formerly known as hyaline membrane disease, is a common problem in preterm infants. This disorder is caused primarily by deficiency of pulmonary surfactant in an immature lung. RDS is a major cause of morbidity and mortality in preterm infants.
Surfactant therapy has been shown to significantly reduce neonatal and infant mortality. Corticosteroids are given antenatal, and then surfactant is given, along with corticosteroids, postnatal.
A single course of corticosteroids is recommended for pregnant women between 24 weeks and 34 weeks of gestation who are at risk of preterm delivery within 7 days, including those with ruptured membranes and multiple pregnancies.
Betamethasone is recommended as the steroid of choice, to be administered in two doses of 12 mg given intramuscularly 24 hours apart.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impact of antenatal corticosteroid therapy on surfactants use postnatal | – | Other: Impact of antenatal corticosteroid therapy on surfactants use postnatalIntervention Description: Retrospective study on preterm infants to evaluate the impact of antenatal corticosteroid therapy on surfactants use postnatal |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants (≤ 37 SA), hospitalized in the neonatal intensive care unit between January 2018 and December 2019 and having received at least one dose of corticosteroids antenatal
Key inclusion criteria (3 listed)
- Preterm infants ≤ 37 SA
- Hospitalized in the neonatal intensive care unit between January 2018 and December 2019
- Having received at least one dose of corticosteroids antenatal
Key exclusion criteria (2 listed)
- Parental Opposition
- Congenital malformations that may cause neonatal respiratory distress.
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 |
|---|---|---|
| Impact of antenatal corticosteroid therapy on surfactants use postnatalIntervention Description: Retrospective study on preterm infants to evaluate the impact of antenatal corticosteroid therapy on surfactants use postnatal | Other | Impact of antenatal corticosteroid therapy on surfactants use postnatal |
Primary outcome
Assessment of the effect of a full course of antenatal corticosteroid therapy versus a half course on the number of postnatal surfactant doses in preterm infants.
Time frame: At the end of the study, an average of 2 month
Comparison of the number of doses of surfactants administered postnatal in preterm infants who received 2 doses of antenatal corticosteroid therapy versus those who received a single dose
5 secondary outcomes
Assessment of the influence of gestational age on the severity of hyaline membrane disease (HMD)
Time frame: At the end of the study, an average of 2 month
Assessment of the influence of the cause of prematurity on the severity of hyaline membrane disease (HMD)
Time frame: At the end of the study, an average of 2 month
Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the use of postnatal corticosteroid therapy
Time frame: At the end of the study, an average of 2 month
Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the prevalence of bronchopulmonary dysplasia
Time frame: At the end of the study, an average of 2 month
Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the severity of intraventricular hemorrhage
Time frame: At the end of the study, an average of 2 month
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 19 Sep 2024.
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 Suzanne BORRHOMEE principal investigator
Hôpital NOVO
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 Hyaline Membrane Disease (HMD), run by Hôpital NOVO at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 19 Sep 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 France. 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?
Assessment of the effect of a full course of antenatal corticosteroid therapy versus a half course on the number of postnatal surfactant doses in preterm infants. (time frame: At the end of the study, an average of 2 month). 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 19 Sep 2024.