Hyaline Membrane DiseaseACTLPTNCT00675246
Antenatal Corticoid Therapy for Late Preterm Babies
A study testing Betamethasone in people with Hyaline Membrane Disease and Transient Tachypnea, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
This study aims to determine the effectiveness of antenatal corticosteroid therapy in late preterm babies. The investigators hypothesis is corticoid accelerates fetal lung maturation even after 34 weeks and reduces risk of respiratory distress syndrome and other neonatal morbidities. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Hyaline Membrane Disease, Transient Tachypnea
- What is being tested?
- Betamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteBrazil
- Study dates
- May 2008to May 2010
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnancy between 34 and 36 weeks
- Confirmed gestational age (LMP, USG)
- Alive fetus
- Imminent risk of preterm delivery
Who cannot join
- Multiple pregnancy
- Major fetal malformations
- Comproved fetal lung maturity
- Maternal or fetal indication for immediate interruption of pregnancy
- Maternal hemorrhagic syndromes (placenta previa, abruptio placenta)
- Chorioamnionitis
- Chronic use of corticosteroids
- Previous use of corticosteroids for fetal lung maturation in the current pregnancy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Materno Infantil Prof. Fernando Figueira
Recife, Pernambuco, 50070550
About this study
Official title: Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial
This study aims to determine the effectiveness of antenatal corticosteroid therapy in late preterm babies. The investigators hypothesis is corticoid accelerates fetal lung maturation even after 34 weeks and reduces risk of respiratory distress syndrome and other neonatal morbidities.
Read the detailed description
Late preterm babies have important morbidity when compared with term babies, with oxygen requirement and more days of hospitalization. If antenatal corticosteroid therapy is necessary for fetal lung maturation after 34 weeks, it remains to be established. The systematic review with metanalysis in Cochrane Library includes a small number of late preterm babies and no conclusion about effectiveness of corticoid therapy in this setting could be drawn. Our hypothesis is that antenatal corticosteroid therapy is effective to prevent respiratory disease and morbidity in late preterm babies and this study will be carried out to evaluate this question.
- Conditions
- Hyaline Membrane Disease, Transient Tachypnea
- Being tested
- Betamethasone
- Keywords
- corticoid therapy, fetal lung maturation, late preterm, respiratory distress syndrome, neonatal death
- Medical subject headings
- Hyaline Membrane Disease, Respiratory Distress Syndrome, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
Also called CELESTONE SOLUSPAN (MANTECORP)
IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Antenatal corticoid therapy Receives: Drug: Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal respiratory distress
Measured: neonatal period (28 days of life)
Secondary outcomes (4)
during of neonatal hospitalization
Measured: neonatal period (28 days of life)
neonatal oxygen requirement
Measured: neonatal period (28 days of life)
neonatal sepsis
Measured: neonatal period (28 days of life)
neonatal death
Measured: neonatal period (28 days of life)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2010
- Study completionMay 2010
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 Hyaline Membrane DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Investigators
- Melania Amorim, MD, PhD, Study director, Instituto Materno Infantil Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675246
- Sponsor's protocol ID
- CORTICOID001
- Acronym
- ACTLPT
- Status last verified
- Jun 2010
- First submitted
- 7 May 2008
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Porto AM, Coutinho IC, Correia JB, Amorim MM. Effectiveness of antenatal corticosteroids in reducing respiratory disorders in late preterm infants: randomised clinical trial. BMJ. 2011 Apr 12;342:d1696. doi: 10.1136/bmj.d1696.
PubMed 21487057
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00675246
- Acronym / sponsor ID
- ACTLPT / CORTICOID001
- Conditions
- Hyaline Membrane Disease, Transient Tachypnea
- Keywords
- corticoid therapy, fetal lung maturation, late preterm, respiratory distress syndrome, neonatal death
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 May 2008 (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.
This study aims to determine the effectiveness of antenatal corticosteroid therapy in late preterm babies. The investigators hypothesis is corticoid accelerates fetal lung maturation even after 34 weeks and reduces risk of respiratory distress syndrome and other neonatal morbidities.
Detailed description
Late preterm babies have important morbidity when compared with term babies, with oxygen requirement and more days of hospitalization. If antenatal corticosteroid therapy is necessary for fetal lung maturation after 34 weeks, it remains to be established. The systematic review with metanalysis in Cochrane Library includes a small number of late preterm babies and no conclusion about effectiveness of corticoid therapy in this setting could be drawn. Our hypothesis is that antenatal corticosteroid therapy is effective to prevent respiratory disease and morbidity in late preterm babies and this study will be carried out to evaluate this question.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: BetamethasoneAntenatal corticoid therapy |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnancy between 34 and 36 weeks
- Confirmed gestational age (LMP, USG)
- Alive fetus
- Imminent risk of preterm delivery
Key exclusion criteria (8 listed)
- Multiple pregnancy
- Major fetal malformations
- Comproved fetal lung maturity
- Maternal or fetal indication for immediate interruption of pregnancy
- Maternal hemorrhagic syndromes (placenta previa, abruptio placenta)
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 |
|---|---|---|
| BetamethasoneAlso: CELESTONE SOLUSPAN (MANTECORP)IM administration of 12mg of betamethasone each 24 hours (total dose=24mg) | Drug | A |
Primary outcome
neonatal respiratory distress
Time frame: neonatal period (28 days of life)
4 secondary outcomes
during of neonatal hospitalization
Time frame: neonatal period (28 days of life)
neonatal oxygen requirement
Time frame: neonatal period (28 days of life)
neonatal sepsis
Time frame: neonatal period (28 days of life)
neonatal death
Time frame: neonatal period (28 days of life)
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 9 Jun 2010.
- Derived from this study: PubMed 21487057Porto AM, Coutinho IC, Correia JB, Amorim MM. Effectiveness of antenatal corticosteroids in reducing respiratory disorders in late preterm infants: randomised clinical trial. BMJ. 2011 Apr 12;342:d1696. doi: 10.1136/bmj.d1696.
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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.
Melania Amorim, MD, PhD study director
Instituto Materno Infantil Prof. Fernando Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betamethasone in people with Hyaline Membrane Disease and Transient Tachypnea, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
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 4 inclusion and 8 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 9 Jun 2010. 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 Brazil. 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?
neonatal respiratory distress (time frame: neonatal period (28 days of life)). 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 NCT00675246, 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 9 Jun 2010.