Respiratory MorbidityLoDACNCT05698966
Low Dose Antenatal Corticosteroids for Late Preterm Delivery
A study testing we will use reduced dose of acceptable corticosteroids treatment for preterm birth in people with Respiratory Morbidity and Preterm Labor, run by Rambam Health Care Campus at 16 sites in Israel.
Trial summary
This is a study proposal for a clinical trial to evaluate the effectiveness of a reduced dose of antenatal betamethasone (a steroid medication) in preventing respiratory problems in late preterm infants (born between 34 and 36 weeks of gestation). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Respiratory Morbidity, Preterm Labor
- What is being tested?
- we will use reduced dose of acceptable corticosteroids treatment for preterm birth
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,510 participants
- Where
- 16 sitesIsrael
- Study dates
- 1 Jan 2022to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria:- - Singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation at risk for / high probability of delivery in the late preterm period (34+0-36+5 weeks of gestation).
Criteria for determination of late preterm delivery risk:
- Preterm uterine contractions with intact membranes, and at least 3 cm dilation or 75% cervical effacement
- Spontaneous rupture of the membranes
- Expected preterm delivery for any other indication via induction or cesarean between 24 hours to 7 days after the planned randomization, as determined by the obstetric provider. - Exclusion Criteria: They had already received a full course of betamethasone.
- Expected delivery in less than 12 hours, irrespective of cause including: 1)ruptured membranes in the presence of more than 6 contractions per hour or cervical dilation of 3 centimeters or more unless oxytocin was withheld for at least 12 hours (although other induction agents were allowed), 2) chorioamnionitis, 3) cervical dilation of 8 cm or more, and 4) evidence of non-reassuring fetal status requiring immediate delivery.
- Prior ACS treatment
- Current known or suspected infection ( viral, bacterial or other)
- Pre-gestational diabetes mellitus.
- Any infection that required antibiotics or hospitalization in the month prior to study allocation - Poor understanding of the inform consent language
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Israel16 sites, 16 recruiting
- Recruiting
Emek Medical Center
Afula
Noa Zafran, MD
- Recruiting
Kaplan Medical Center
Ashkelon
Edi Vaisbuch, MD
- Recruiting
Soroka Medical Center
Beersheba
Noa Aleluya, MD
- Recruiting
Hilel Yafee Medical Center
Hadera
Rinat Gabbay, MD
- Recruiting
Bnai Zion Medical Center
Haifa
Rami Sammour, MD
- Recruiting
Carmel Medical Center
Haifa
Nir Kugelman, MD
- Recruiting
Rambam Health Care Cmpus
Haifa
Ron Beloosesky, M.D
- Recruiting
Hadassah Ein Karem
Jerusalem
Doron Cabiri
- Recruiting
Hadassah Har Hzofim
Jerusalem
Lorin Levit Rosen, MD
- Recruiting
Shaare Zedek Medical Center
Jerusalem
Sorina Grisaru, MD
- Recruiting
Meir medical center
Kfar Saba
Or Elinor, MD
- Recruiting
Galilee Medical Center
Nahariya
Maya Wolf, MD
- Recruiting
Rabin Medical Center
Petah Tikva
Sivan Easton, MD
- Recruiting
Sheba Medical Center
Ramat Gan
Yoav Yinon, MD
- Recruiting
Ziv Medical Center
Safed
Yael Sciaky-Tamir, MD
- Recruiting
Sourasky Medical Center
Tel Aviv
Liran Hirsh
About this study
Official title: Low Dose Antenatal Corticosteroids for Late Preterm Delivery (LoDAC Study)
This is a study proposal for a clinical trial to evaluate the effectiveness of a reduced dose of antenatal betamethasone (a steroid medication) in preventing respiratory problems in late preterm infants (born between 34 and 36 weeks of gestation). The study will be conducted in medical centers in Israel and will involve women who are at high risk for delivering a late preterm infant. The participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants.
Read the detailed description
Antenatal corticosteroids (ACS) are a type of steroid medication that is administered to pregnant women at risk of preterm birth in order to reduce the risk of respiratory distress syndrome (RDS) and other complications in the newborn. ACS were first demonstrated to be effective in a controlled trial conducted in the 1970s by Liggins and Howie, who used a combination of betamethasone at a dose of 12 mg given in two doses 24 hours apart. Since then, numerous randomized controlled trials and meta-analyses have shown that ACS can significantly reduce neonatal death, RDS, intraventricular hemorrhage, necrotizing enterocolitis, and the need for respiratory support and neonatal intensive care unit admission in preterm infants. ACS are now recommended for use in virtually all pregnancies at risk of preterm delivery between 24 and 34 weeks of gestation. The use of ACS in late preterm pregnancies (between 34 and 37 weeks) has also been studied, with mixed results. The largest study to date, the ALPS trial, found that ACS reduced composite adverse outcomes and respiratory morbidity in late preterm infants, but did not significantly reduce the risk of RDS or mortality. The American Congress of Obstetricians and Gynecologists has recommended the use of ACS in late preterm pregnancies, but with caution due to the potential for adverse effects such as hypoglycemia. Long-term follow-up studies are needed to evaluate the potential long-term effects of ACS in late preterm infants. In this the participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants.
- Conditions
- Respiratory Morbidity, Preterm Labor
- Being tested
- we will use reduced dose of acceptable corticosteroids treatment for preterm birth
- Keywords
- corticosteroids, low dose, late prerterm
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
we will use reduced dose of acceptable corticosteroids treatment for preterm birthOther
the two different group will differ in the doses of corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| betamethasone 12 mg | Active comparator | 3 mg betamethasone sodium phosphate and 3 mg betamethasone acetate per milliliter. The first dose of study drug medication will be administered at randomization as 2 ml injection; the next dose of 2 ml will be administered 24 hours later Receives: Other: we will use reduced dose of acceptable corticosteroids treatment for preterm birth |
| betamethasone 3 mg | Experimental | 3 mg betamethasone sodium phosphate and 3 mg betamethasone acetate per milliliter. The first dose of study drug medication will be administered at randomization as 0.5 ml injection; the next dose of 0.5 ml will be administered 24 hours later Receives: Other: we will use reduced dose of acceptable corticosteroids treatment for preterm birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory morbidity
- Use of continuous positive airway pressure (CPAP) or high-flow nasal cannula for ≥2 continuous hr in the first 72 hours
- Fraction of inspired oxygen of ≥0.30 for ≥4 continuous hr in the first 72 hours
- Mechanical ventilation in the firdt 72 hours yes/no
- extracorporeal membrane oxygenation (ECMO) yes/no
- TTN: transient tachypnea of newborn yes/no
Measured: first 72 hours after birth
Secondary outcomes (1)
other neonatal morbidities other neonatal morbidities
for all the parameters: yes or no Severe respiratory complications (a composite outcome of CPAP or high-flow nasal cannula for at least 12 continuous hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least at least 24 continuous hours, ECMO or mechanical ventilation, stillbirth, or neonatal death within 72 hours after delivery) Respiratory distress syndrome, Transient tachypnea of the newborn, Apnea, Bronchopulmonary dysplasia, Surfactant administration, Need for resuscitation at birth , Feeding difficulty, Hypothermia, , Necrotizing enterocolitis, Intraventricular hemorrhage Papile grade 3 or 4, Neonatal sepsis, Pneumonia, Pulmonary air leak, Death before discharge
Newborns blood levels of glucose: mg/dl insulin and c-peptide : levels in serum
Measured: first 30 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MorbidityStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ron Beloosesky MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698966
- Sponsor's protocol ID
- 00451890
- Acronym
- LoDAC
- Status last verified
- Apr 2024
- First submitted
- 31 Dec 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Antenatal Corticosteroids for Late Preterm Delivery (LoDAC Study)
- ClinicalTrials.gov ID
- NCT05698966
- Acronym / sponsor ID
- LoDAC / 00451890
- Conditions
- Respiratory Morbidity, Preterm Labor
- Keywords
- corticosteroids, low dose, late prerterm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,510 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 26 Jan 2023 (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.
This is a study proposal for a clinical trial to evaluate the effectiveness of a reduced dose of antenatal betamethasone (a steroid medication) in preventing respiratory problems in late preterm infants (born between 34 and 36 weeks of gestation). The study will be conducted in medical centers in Israel and will involve women who are at high risk for delivering a late preterm infant. The participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants.
Detailed description
Antenatal corticosteroids (ACS) are a type of steroid medication that is administered to pregnant women at risk of preterm birth in order to reduce the risk of respiratory distress syndrome (RDS) and other complications in the newborn. ACS were first demonstrated to be effective in a controlled trial conducted in the 1970s by Liggins and Howie, who used a combination of betamethasone at a dose of 12 mg given in two doses 24 hours apart. Since then, numerous randomized controlled trials and meta-analyses have shown that ACS can significantly reduce neonatal death, RDS, intraventricular hemorrhage, necrotizing enterocolitis, and the need for respiratory support and neonatal intensive care unit admission in preterm infants. ACS are now recommended for use in virtually all pregnancies at risk of preterm delivery between 24 and 34 weeks of gestation. The use of ACS in late preterm pregnancies (between 34 and 37 weeks) has also been studied, with mixed results. The largest study to date, the ALPS trial, found that ACS reduced composite adverse outcomes and respiratory morbidity in late preterm infants, but did not significantly reduce the risk of RDS or mortality. The American Congress of Obstetricians and Gynecologists has recommended the use of ACS in late preterm pregnancies, but with caution due to the potential for adverse effects such as hypoglycemia. Long-term follow-up studies are needed to evaluate the potential long-term effects of ACS in late preterm infants. In this the participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| betamethasone 12 mg | Active comparator | Other: we will use reduced dose of acceptable corticosteroids treatment for preterm birth3 mg betamethasone sodium phosphate and 3 mg betamethasone acetate per milliliter. The first dose of study drug medication will be administered at randomization as 2 ml injection; the next dose of 2 ml will be administered 24 hours later |
| betamethasone 3 mg | Experimental | Other: we will use reduced dose of acceptable corticosteroids treatment for preterm birth3 mg betamethasone sodium phosphate and 3 mg betamethasone acetate per milliliter. The first dose of study drug medication will be administered at randomization as 0.5 ml injection; the next dose of 0.5 ml will be administered 24 hours later |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| we will use reduced dose of acceptable corticosteroids treatment for preterm birththe two different group will differ in the doses of corticosteroids | Other | betamethasone 12 mg, betamethasone 3 mg |
Primary outcome
Respiratory morbidity
Time frame: first 72 hours after birth
1. Use of continuous positive airway pressure (CPAP) or high-flow nasal cannula for ≥2 continuous hr in the first 72 hours 2. Fraction of inspired oxygen of ≥0.30 for ≥4 continuous hr in the first 72 hours 3. Mechanical ventilation in the firdt 72 hours yes/no 4. extracorporeal membrane oxygenation (ECMO) yes/no 5. TTN: transient tachypnea of newborn yes/no
1 secondary outcome
other neonatal morbidities other neonatal morbidities
Time frame: first 30 days after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Respiratory Morbidity
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Delayed Versus Immediate Cord Clamping in Preterm Birth
Preterm Birth Complication, Neonatal Morbidity and Mortality
RecruitingObservational study
Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
Influenza, COVID-19
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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing we will use reduced dose of acceptable corticosteroids treatment for preterm birth in people with Respiratory Morbidity and Preterm Labor, run by Rambam Health Care Campus at 16 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ron Beloosesky, MD (0509205759, tomor2304@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory morbidity (time frame: first 72 hours after birth). 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 10 Apr 2024.