Preterm DeliveryNCT00453141
Betamethasone Dosing Interval - 12 or 24 Hours?
A study testing dosing of Betamethasone in people with Preterm Delivery, run by The Cooper Health System at 2 sites in United States.
Trial summary
The purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Delivery
- What is being tested?
- dosing of Betamethasone
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Oct 2009
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women expected to deliver preterm (either induced or spontaneously) for any obstetrical or medical indication.
- Gestational age between 23 and 34 weeks gestational age.
- Dating must either be by LMP which is consistent with ultrasound performed at any gestational age, or calculated by a sonogram less than or equal to 23 weeks.
Who cannot join
- Patients at <23 or >34 weeks gestational age.
- Known drug allergy to betamethasone.
- Given steroid other than betamethasone for lung maturation.
- Any contraindication to steroid therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cooper University Hospital
Camden, New Jersey, 08103
Atlanticare Regional Medical Center
Pomona, New Jersey
About this study
The purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart.
Read the detailed description
Betamethasone is a medicine given to women expected to deliver after 24 but before 34 weeks of pregnancy. It is very advantageous in preventing or decreasing the many problems these small babies may face if born early. Betamethasone makes breathing easier for them, also decreases the chance of them bleeding in the head and makes their chances of survival better. This medicine is used routinely in pregnancy but the best timing between doses in not well established. The 'standard' dosing schedule involves giving 2 injections of 12mg of the medicine 24 hours apart. However, many women deliver before reaching the 24-hour mark, despite the doctors best efforts to try and delay delivery, and therefore miss the opportunity for the 2nd dose.
- Conditions
- Preterm Delivery
- Being tested
- dosing of Betamethasone
- Keywords
- Betamethasone for preterm labor, Preterm delivery, Infant Respiratory Distress Syndrome
- Medical subject headings
- Premature Birth, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dosing of BetamethasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnosis of RDS is defined as: PaO2 < 50 mm Hg in room air, central cyanosis in room air, or a requirement for supplemental O2 to maintain PaO2 > 50 mm Hg, along with chest xray findings consistent with RDS (per the Vermont Oxford Network)
Measured: Until neonatal discharge
Secondary outcomes (1)
Incidence of INH, NEC, BPD, Blindness
Measured: until neonatal discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startApr 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm DeliveryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Investigators
- Meena Khandelwal, MD, Principal investigator, The Cooper Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453141
- Sponsor's protocol ID
- 06030
- Status last verified
- Mar 2009
- First submitted
- 26 Mar 2007
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Liggins GC, Howie RN. A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants. Pediatrics. 1972 Oct;50(4):515-25. No abstract available.
PubMed 4561295
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Betamethasone Dosing Interval - 12 or 24 Hours?
- ClinicalTrials.gov ID
- NCT00453141
- Acronym / sponsor ID
- 06030
- Conditions
- Preterm Delivery
- Keywords
- Betamethasone for preterm labor, Preterm delivery, Infant Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 28 Mar 2007 (estimated)
- 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.
The purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart.
Detailed description
Betamethasone is a medicine given to women expected to deliver after 24 but before 34 weeks of pregnancy. It is very advantageous in preventing or decreasing the many problems these small babies may face if born early. Betamethasone makes breathing easier for them, also decreases the chance of them bleeding in the head and makes their chances of survival better. This medicine is used routinely in pregnancy but the best timing between doses in not well established. The 'standard' dosing schedule involves giving 2 injections of 12mg of the medicine 24 hours apart. However, many women deliver before reaching the 24-hour mark, despite the doctors best efforts to try and delay delivery, and therefore miss the opportunity for the 2nd dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pregnant women expected to deliver preterm (either induced or spontaneously) for any obstetrical or medical indication.
- Gestational age between 23 and 34 weeks gestational age.
- Dating must either be by LMP which is consistent with ultrasound performed at any gestational age, or calculated by a sonogram less than or equal to 23 weeks.
Key exclusion criteria (4 listed)
- Patients at <23 or >34 weeks gestational age.
- Known drug allergy to betamethasone.
- Given steroid other than betamethasone for lung maturation.
- Any contraindication to steroid therapy.
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 |
|---|---|---|
| dosing of Betamethasone | Drug | – |
Primary outcome
The diagnosis of RDS is defined as: PaO2 < 50 mm Hg in room air, central cyanosis in room air, or a requirement for supplemental O2 to maintain PaO2 > 50 mm Hg, along with chest xray findings consistent with RDS (per the Vermont Oxford Network)
Time frame: Until neonatal discharge
1 secondary outcome
Incidence of INH, NEC, BPD, Blindness
Time frame: until neonatal discharge
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 10 Nov 2009.
- Background: PubMed 4561295Liggins GC, Howie RN. A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants. Pediatrics. 1972 Oct;50(4):515-25. No abstract available.
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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.
Meena Khandelwal, MD principal investigator
The Cooper Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dosing of Betamethasone in people with Preterm Delivery, run by The Cooper Health System at 2 sites in United States.
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 4 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 10 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The diagnosis of RDS is defined as: PaO2 < 50 mm Hg in room air, central cyanosis in room air, or a requirement for supplemental O2 to maintain PaO2 > 50 mm Hg, along with chest xray findings consistent with RDS (per the Vermont Oxford Network) (time frame: Until neonatal discharge). 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 NCT00453141, which also lists 1 linked publication.
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 10 Nov 2009.