Respiratory Distress Syndrome, NewbornPhase 2NCT01206946
Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants
A Phase 2 study testing Betamethasone and Normal Saline in people with Respiratory Distress Syndrome, Newborn and Transient Tachypnea of the Newborn, run by American University of Beirut Medical Center at 5 sites in Lebanon.
Trial summary
The hypothesis of the study is that administration of antenatal steroid to women at high risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the Newborn (TTN) in late preterm babies. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn
- What is being tested?
- Betamethasone and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 5 sitesLebanon
- Study dates
- Sep 2010to Sep 2013
- Phase
- Phase 2
- 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
- Women between 34 0/7- 36 6/7 weeks of gestation
- High risk of preterm birth
Who cannot join
- Multiple births
- Fetal congenital malformations
- A course of steroids within 2 weeks of randomization
- Multiple courses of steroids
- Chorioamnionitis
- Non reassuring fetal heart rate
Show all 10Show fewer
- Obstetrical indication of delivery
- Active bleeding
- Pregnancy related hypertensive disorders
- Uncontrolled diabetes
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Lebanon5 sites, 5 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut
Khalid Yunis, MD
Lama Charafeddine, MD
- Recruiting
Bahman Hospital
Beirut
Ali Zaytoun, MD
Iman Charara, MD
- Not yet recruiting
Hotel Dieu de France
Beirut
Imad Melki, MD
Elie Atiyeh, MD
- Recruiting
Rafik Hariri University Hospital
Beirut
Hassan Fakhoury, MD
Zoulfikar Hachach, MD
- Not yet recruiting
St Georges Hospital- University Medical Center
Beirut
Georged El Kehdy, MD
Dany Hamod, MD
About this study
Official title: Effect of Antenatal Steroids for Women at Risk of Late Preterm Delivery on Neonatal Respiratory Morbidity
The hypothesis of the study is that administration of antenatal steroid to women at high risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the Newborn (TTN) in late preterm babies.
- Being tested
- Betamethasone, Normal Saline
- Keywords
- Respiratory distress, Antenatal steroids, late preterm
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)
Normal SalineOther
Two doses of 2ml of normal saline given at 24 hourly intervals
| Study group | Role | What they receive |
|---|---|---|
| Antenatal steroids | Experimental | Not described Receives: Drug: Betamethasone |
| Normal saline | Placebo comparator | Not described Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)
Measured: First three days of life
Secondary outcomes (11)
Admission to NICU
Measured: First three days of life
Hospital stay
Measured: Neonatal period (28 days of life)
Days on oxygen
Measured: Neonatal period (28 days of life)
Intubations
Measured: First three days of life
Surfactant treatment
Measured: First three days of life
Pneumothorax
Measured: First three days of life
Persistent Pulmonary Hypertension of the Newborn(PPHN)
Measured: First three days of life
Days on ventilation
Measured: Neonatal period (28 days of life)
Necrotizing enterocolitis (NEC)
Measured: Neonatal period (28 days of life)
Clinical sepsis
Measured: Neonatal period (28 days of life)
Intraventricular Hemorrhage (IVH)
Measured: First week after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (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, NewbornStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Khalid Yunis, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206946
- Sponsor's protocol ID
- PED.KY.11
- Status last verified
- Sep 2010
- First submitted
- 21 Sep 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antenatal Steroids for Women at Risk of Late Preterm Delivery on Neonatal Respiratory Morbidity
- ClinicalTrials.gov ID
- NCT01206946
- Acronym / sponsor ID
- PED.KY.11
- Keywords
- Respiratory distress, Antenatal steroids, late preterm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 22 Sep 2010 (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 hypothesis of the study is that administration of antenatal steroid to women at high risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the Newborn (TTN) in late preterm babies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antenatal steroids | Experimental | Drug: Betamethasone |
| Normal saline | Placebo comparator | Other: Normal Saline |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women between 34 0/7- 36 6/7 weeks of gestation
- High risk of preterm birth
Key exclusion criteria (10 listed)
- Multiple births
- Fetal congenital malformations
- A course of steroids within 2 weeks of randomization
- Multiple courses of steroids
- Chorioamnionitis
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 |
|---|---|---|
| BetamethasoneA single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals) | Drug | Antenatal steroids |
| Normal SalineTwo doses of 2ml of normal saline given at 24 hourly intervals | Other | Normal saline |
Primary outcome
Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)
Time frame: First three days of life
11 secondary outcomes
Admission to NICU
Time frame: First three days of life
Hospital stay
Time frame: Neonatal period (28 days of life)
Days on oxygen
Time frame: Neonatal period (28 days of life)
Intubations
Time frame: First three days of life
Surfactant treatment
Time frame: First three days of life
Pneumothorax
Time frame: First three days of life
Persistent Pulmonary Hypertension of the Newborn(PPHN)
Time frame: First three days of life
Days on ventilation
Time frame: Neonatal period (28 days of life)
Necrotizing enterocolitis (NEC)
Time frame: Neonatal period (28 days of life)
Clinical sepsis
Time frame: Neonatal period (28 days of life)
Intraventricular Hemorrhage (IVH)
Time frame: First week after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
Khalid Yunis, MD principal investigator
American University of Beirut Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Betamethasone and Normal Saline in people with Respiratory Distress Syndrome, Newborn and Transient Tachypnea of the Newborn, run by American University of Beirut Medical Center at 5 sites in Lebanon.
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 2 inclusion and 10 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 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Lebanon. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Khalid Yunis, MD (961-1-350000 ext. 5538, kayunis@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN) (time frame: First three days of life). 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 23 Jun 2011.