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Trial record 3 of 272 for:    Betamethasone

Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth (BETADOSE)

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ClinicalTrials.gov Identifier: NCT02897076
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Extensive animal studies have indicated that antenatal betamethasone exposure results in altered developmental trajectories of several fetal systems. Follow up of a randomized controlled trial has shown that antenatal betamethasone exposure might result in insulin resistance 30 years later. Furthermore, animal studies and randomized trials in Humans have clearly demonstrated that betamethasone-induced growth alterations were dose-related.

In ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung function, similar to those obtained after a full dose.

Our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the potential long term effects of this drug, is not inferior to a full dose to promote fetal lung maturation in Humans.


Condition or disease Intervention/treatment Phase
Neonatal Complications Drug: betamethasone 24 mg Drug: 12mg betamethasone +placebo Phase 3

Detailed Description:

The BETADOSE project consist in a randomized, multicenter, double blind placebo-controlled non inferiority trial comparing a standard dose regimen (24 mg) to a reduced dose regimen (12 mg) of betamethasone given to prevent the neonatal complications associated with very preterm birth.A betamethasone course consists in 2 injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg.

The first injection will be unmasked in both group. In both group, women will receive a first 12 mg injection of betamethasone according to local protocols.

Randomization will be performed after the first injection. Women will then receive either a placebo injection (reduced dose regimen, 12 mg only from the first injection) or a second 12 mg betamethasone injection (standard dose regimen, 12 mg from the first injection and 12 mg from the second injection=24 mg). This protocol allows women sent from level 1 and 2 to level 3 perinatal centers after having already received their first injection to participate.

In case of multiple antenatal betamethasone courses, women will receive their second course according to the same design as in their first course.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth: a Randomized, Multicentre, Double Blind Placebo-controlled Non Inferiority Trial
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Active Comparator: 12mg betamethasone+12mg betamethasone

A betamethasone course consists in 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg.

In the BETADOSE trial, the first injection will be unmasked in both groups. In both groups, women will received a first 12 mg injection of betamethasone according to local protocols.

Randomization will be performed after the first injection. Women will then received either a blinded placebo injection (50% reduced dose regimen, 12 mg only from the first injection) or a second blinded 12 mg betamethasone injection (standard full dose regimen, 12 mg from the first injection and 12 mg from the second injection=24 mg).

Drug: betamethasone 24 mg
Placebo Comparator: 12 mg betamethasone+ placebo

A betamethasone course consists in 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg.

In the BETADOSE trial, the first injection will be unmasked in both groups. In both groups, women will received a first 12 mg injection of betamethasone according to local protocols.

Randomization will be performed after the first injection. Women will then received either a blinded placebo injection (50% reduced dose regimen, 12 mg only from the first injection) or a second blinded 12 mg betamethasone injection (standard full dose regimen, 12 mg from the first injection and 12 mg from the second injection=24 mg).

Drug: 12mg betamethasone +placebo



Primary Outcome Measures :
  1. severe RDS defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life [ Time Frame: 48 hours of life ]
    The primary assessment criterion is severe respiratory distress syndrome(RDS) defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life. It is considered as a binary endpoint: failure if there is occurrence of RDS, or not failure.


Secondary Outcome Measures :
  1. highest appropriate fractional inspired oxygen (FiO2) [ Time Frame: 48 hours of life ]
  2. maximum appropriate Mean Airway Pressure (MAP) [ Time Frame: 48 hours of life ]
  3. duration of mechanical ventilation [ Time Frame: 36 weeks post conception ]
  4. duration of oxygen therapy [ Time Frame: 36 weeks post conception ]
  5. oxygen therapy [ Time Frame: 36 weeks post conception ]
  6. neonatal death [ Time Frame: 36 weeks post conception ]
  7. admission to neonatal intensive care unit [ Time Frame: 36 weeks post conception ]
  8. inotropic support [ Time Frame: 36 weeks post conception ]
  9. air leak syndrome [ Time Frame: 36 weeks post conception ]
  10. patent ductus arteriosus [ Time Frame: 36 weeks post conception ]
  11. necrotising enterocolitis [ Time Frame: 36 weeks post conception ]
  12. intraventricular hemorrhage and grade [ Time Frame: 36 weeks post conception ]
  13. periventricular leukomalacia [ Time Frame: 36 weeks post conception ]
  14. use of postnatal steroids [ Time Frame: 36 weeks post conception ]
  15. retinopathy of prematurity [ Time Frame: 36 weeks post conception ]
  16. length of hospital stay [ Time Frame: 36 weeks post conception ]
  17. early onset sepsis [ Time Frame: 36 weeks post conception ]
  18. Composite endpoint of any of the 4 prematurity-induced complications related to the use of betamethasone [ Time Frame: 36 weeks post conception ]

    Related to betamethasone impact on other prematurity-induced complications, is a composite outcome taking into account multiple clinical events :

    neonatal death, severe RDS defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life, intraventricular hemorrhage high grade, and necrotising enterocolitis.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Patient Having receipt the first injection of betamethasone and pregnancy term < 32 weeks of gestation
  • Age > 18 years
  • Patient affiliated to a social security regime

Exclusion Criteria:

  • Chromosomal aberrations and major fetal malformations
  • Cervical dilatation ≥ 4 cm and of cervical length ≥20mm.
  • Patient who have already received a first course of betamethasone
  • first intravenous injection of betamethasone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897076


Contacts
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Contact: SCHMITZ THOMAS, PHD 00331 40 03 12 38 thomas.schmitz@aphp.fr
Contact: BAUD OLIVIER, PHD 00331 40 03 41 09 olivier.baud@aphp.fr

Locations
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France
Hôpital Robert Debré Recruiting
Paris, France, 75019
Contact: Schmitz Thomas, Phd       Thomas.schmitz@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Schmitz Thomas, PHD APHP

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02897076     History of Changes
Other Study ID Numbers: P150944
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents