PPROMPhase 2/3NCT02939742
Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?
A Phase 2/3 study testing Betamethasone in people with PPROM and Respiratory Distress Syndrome in Premature Infants, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity associated with this condition. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PPROM, Respiratory Distress Syndrome in Premature Infants
- What is being tested?
- Betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 20 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maternal age ≥ 18 years
- Preterm premature rupture of membranes, demonstrated clinically by speculum exam
- Cervical dilation visually ≤ 5cm on sterile speculum exam
- Planned delivery at John Sealy Hospital (JSH)
- Gestational age of membrane rupture and initiation of first course of antenatal corticosteroids between 23 5/7 - 32 5/7 weeks
- Planned pregnancy continuation with no indication for delivery for at least 7 days
Who cannot join
- Maternal age > 50 years
- Gestational age < 23 5/7 weeks or > 32 5/7 weeks
- Known major congenital abnormalities, aneuploidy, or genetic syndrome
- Intrauterine fetal demise
- Any indication for expedited delivery
- Maternal chorioamnionitis
- Known allergy or adverse reaction to corticosteroids
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch in Galveston
Galveston, Texas, 77555
About this study
Official title: Does a Repeat Course of Antenatal Corticosteroids in Pregnant Women With Preterm Premature Rupture of Membranes Decrease Neonatal Morbidity?
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity associated with this condition.
Read the detailed description
While the fetal benefits of a repeat course of antenatal corticosteroids have been demonstrated in several randomized controlled studies, to the investigators' knowledge they have not been adequately demonstrated in women with PPROM. Given the potential benefit of a repeat course of antenatal corticosteroids in women with PPROM on decreasing neonatal morbidity and the reassuring data from various cohorts on its safety, the investigators sought to propose a randomized controlled trial (RCT) with the hypothesis that a repeat course of antenatal corticosteroids in women with PPROM decreases neonatal morbidity.
Objectives
- To evaluate the impact of maternal treatment with a second course of betamethasone on infant length of stay in the NICU.
- To evaluate the impact of maternal treatment with a second course of betamethasone on the duration of neonatal need for oxygen supplementation.
- To evaluate the impact of maternal treatment with a second course of betamethasone on neonatal morbidity overall.
Hypotheses The investigators hypothesize that treatment of women with PPROM between 24 and 34 weeks of gestation with a repeat course of antenatal corticosteroids decreases infant length of stay in the NICU and neonatal morbidity.
Aim To describe and compare the neonatal outcomes of PPROM infants exposed to a repeat course of antenatal corticosteroids compared to infants in the same antenatal conditions who are exposed to only one betamethasone course.
Subject Safety and Data Monitoring This study does not place subjects at risk of their safety. This medication is well studied and known to be safe in pregnancy.
Data monitoring will be performed and viewed by study personnel only. The data will be de-identified and a study number will be assigned to each patient. The patient's identity will be secured on a UTMB encrypted laptop device and a hard copy stored in the locked file cabinet in the locked office of the principal investigator.
Procedures to Maintain Confidentiality:
Data will be viewed by study personnel only. The data will then be de-identified and a study number will be assigned to each patient. The patient's identity will then be secured on a UTMB encrypted laptop device and a hard copy stored in the locked file cabinet in the locked office of the principal investigator.
Potential Benefits The potential benefits to subjects participating in the study include possible decreased neonatal morbidity and length of stay in the NICU.
Biostatistics Using data from the University of Texas Medical Branch (UTMB) on women with PPROM between 24 and 34 weeks, who fit the inclusion criteria, and who received the standard one course of betamethasone, the average length of stay in the NICU was 59.3 ± 36.3 days. The gestational age at delivery in this cohort was 26.5 ± 3.2 weeks.
Assuming that a second course of betamethasone reduces the length of stay needed in the NICU by 35%, and for a power of 80% and alpha 0.05, it is anticipated that enrollment of 49 women in each group will be needed, or 98 women total.
At UTMB, there are approximately 400 women per year hospitalized with PPROM. Assuming 50% of eligible women consent, the investigators estimate to finish recruitment for this study in 1-2 years.
Sample Size and Assumptions
- Frequency of primary outcome in control group (single course of betamethasone): is 59.3 days. The investigators assume a 35% reduction in length of NICU stay using two courses of betamethasone.
- α = 0.05, two sided
- β = 0.2
- Effect size: 35% reduction in primary outcome
- Being tested
- Betamethasone, Placebo
- Keywords
- preterm premature rupture of membranes, complications of prematurity, neonatal morbidity, respiratory distress syndrome, antenatal corticosteroids, betamethasone
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Respiratory Distress Syndrome In Premature Infants, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
Also called Celestone
Betamethasone 12mg IM given every 24 hours for two doses
PlaceboDrug
Also called Saline placebo
Sterile 0.9% normal saline solution given IM every 24 hours for two doses
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone | Experimental | Women admitted with PPROM who will receive a second course of two betamethasone 12mg intramuscular (IM) injections given 24 hours apart. Receives: Drug: Betamethasone |
| Saline Placebo | Placebo comparator | Women admitted with PPROM who will receive intramuscular saline placebo, given as two injections 24 hours apart. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of Days in the Neonatal Intensive Care Unit (NICU)
Mean number of days participants remained admitted to the Neonatal Intensive Care Unit (NICU) during hospitalization following birth.
Measured: daily from birth of infant up to one year or discharge from the NICU, whichever occurred first
Secondary outcomes (7)
Number of Participants With Composite Neonatal Morbidity
defined as ≥ 1 of the following: RDS (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (requirement for oxygen support at 30 days of life), severe IVH (grades III or IV), periventricular leukomalacia, blood culture-proven sepsis, necrotizing enterocolitis, or perinatal death (stillbirth or death before neonatal hospital discharge)
Measured: assessed daily up to 120 days after birth or discharge from hospital, whichever occured first
Average Number of Days Requiring Supplemental Oxygen or Ventilatory Support
Amount of time, expressed in days from birth, that the infant required supplemental oxygen of any form, including nasal cannula, positive airway pressure, or ventilatory support. Reported as the mean number of days participants required supplemental oxygen therapy or ventilatory support.
Measured: daily from birth until discharge from the NICU or up to 1 year of age, whichever occurred first.
Number of Participants Who Developed Respiratory Distress Syndrome (RDS)
Will be quantified as either present or absent. RDS defined as: compatible symptoms with radiographic evidence of hyaline membrane disease or respiratory insufficiency of prematurity requiring ventilatory support for ≥ 24 hrs
Measured: assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first
Grade III or IV Intraventricular Hemorrhage (IVH)
Will be quantified as either present or absent. Grade III IVH defined as ventricles enlarged by accumulating blood. Grade IV IVH defined as bleeding extending into brain matter around the ventricles.
Measured: assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first
Number of Participants With Neonatal Sepsis
confirmed by culture in the first 72 hours of life
Measured: daily up to 72 hours of life
Number of Participants With Necrotizing Enterocolitis (NEC) Stage 2 or 3
Will be quantified as either present or absent. Stage 2 NEC will be defined as mild to moderate systemic illness, absent bowel sounds, abdominal tenderness, pneumatosis intestinalis or portal venous gas, metabolic acidosis, decreased platelets. Stage 3 NEC will be defined as severely ill, marked distention, signs of peritonitis, hypotension, metabolic \& respiratory acidosis, disseminated intravascular coagulopathy, pneumoperitoneum if bowel perforation present.
Measured: assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first
Number of Perinatal Death(s)
defined as stillbirth or death before neonatal discharge
Measured: assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Why it stopped: Low study recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PPROMStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Bush, MD, Principal investigator, University of Texas Medical Branch in Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939742
- Sponsor's protocol ID
- 15-0280
- Status last verified
- Jun 2026
- First submitted
- 23 Sep 2016
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atarod Z, Taghipour M, Roohanizadeh H, Fadavi S, Taghavipour M. Effects of single course and multicourse betamethasone prior to birth in the prognosis of the preterm neonates: A randomized, double-blind placebo-control clinical trial study. J Res Med Sci. 2014 Aug;19(8):715-9.
PubMed 25422655Brookfield KF, El-Sayed YY, Chao L, Berger V, Naqvi M, Butwick AJ. Antenatal corticosteroids for preterm premature rupture of membranes: single or repeat course? Am J Perinatol. 2015 May;32(6):537-44. doi: 10.1055/s-0034-1396690. Epub 2014 Dec 29.
PubMed 25545441Elimian A, Verma U, Canterino J, Shah J, Visintainer P, Tejani N. Effectiveness of antenatal steroids in obstetric subgroups. Obstet Gynecol. 1999 Feb;93(2):174-9. doi: 10.1016/s0029-7844(98)00400-1.
PubMed 9932550Elimian A, Verma U, Visintainer P, Tejani N. Effectiveness of multidose antenatal steroids. Obstet Gynecol. 2000 Jan;95(1):34-6. doi: 10.1016/s0029-7844(99)00471-8.
PubMed 10636498Gyamfi-Bannerman C, Son M. Preterm premature rupture of membranes and the rate of neonatal sepsis after two courses of antenatal corticosteroids. Obstet Gynecol. 2014 Nov;124(5):999-1003. doi: 10.1097/AOG.0000000000000460.
PubMed 25437730Mazumder P, Dutta S, Kaur J, Narang A. Single versus multiple courses of antenatal betamethasone and neonatal outcome: a randomized controlled trial. Indian Pediatr. 2008 Aug;45(8):661-7.
PubMed 18723909National Institutes of Health Consensus Development Panel. Antenatal corticosteroids revisited: repeat courses - National Institutes of Health Consensus Development Conference Statement, August 17-18, 2000. Obstet Gynecol. 2001 Jul;98(1):144-50. doi: 10.1016/s0029-7844(01)01410-7.
PubMed 11430973Practice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-930. doi: 10.1097/01.AOG.0000435415.21944.8f.
PubMed 24084566Wijnberger LD, Mostert JM, van Dam KI, Mol BW, Brouwers H, Visser GH. Comparison of single and repeated antenatal corticosteroid therapy to prevent neonatal death and morbidity in the preterm infant. Early Hum Dev. 2002 Apr;67(1-2):29-36. doi: 10.1016/s0378-3782(01)00248-1.
PubMed 11893433Yang SH, Choi SJ, Roh CR, Kim JH. Multiple courses of antenatal corticosteroid therapy in patients with preterm premature rupture of membranes. J Perinat Med. 2004;32(1):42-8. doi: 10.1515/JPM.2004.007.
PubMed 15008385
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Repeat Course of Antenatal Corticosteroids in Pregnant Women With Preterm Premature Rupture of Membranes Decrease Neonatal Morbidity?
- ClinicalTrials.gov ID
- NCT02939742
- Acronym / sponsor ID
- 15-0280
- Keywords
- preterm premature rupture of membranes, complications of prematurity, neonatal morbidity, respiratory distress syndrome, antenatal corticosteroids, betamethasone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low study recruitment
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Posted 30 Jun 2026
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 a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity associated with this condition.
Detailed description
While the fetal benefits of a repeat course of antenatal corticosteroids have been demonstrated in several randomized controlled studies, to the investigators' knowledge they have not been adequately demonstrated in women with PPROM. Given the potential benefit of a repeat course of antenatal corticosteroids in women with PPROM on decreasing neonatal morbidity and the reassuring data from various cohorts on its safety, the investigators sought to propose a randomized controlled trial (RCT) with the hypothesis that a repeat course of antenatal corticosteroids in women with PPROM decreases neonatal morbidity.
Objectives
- To evaluate the impact of maternal treatment with a second course of betamethasone on infant length of stay in the NICU.
- To evaluate the impact of maternal treatment with a second course of betamethasone on the duration of neonatal need for oxygen supplementation.
- To evaluate the impact of maternal treatment with a second course of betamethasone on neonatal morbidity overall.
Hypotheses The investigators hypothesize that treatment of women with PPROM between 24 and 34 weeks of gestation with a repeat course of antenatal corticosteroids decreases infant length of stay in the NICU and neonatal morbidity.
Aim To describe and compare the neonatal outcomes of PPROM infants exposed to a repeat course of antenatal corticosteroids compared to infants in the same antenatal conditions who are exposed to only one betamethasone course.
Subject Safety and Data Monitoring This study does not place subjects at risk of their safety. This medication is well studied and known to be safe in pregnancy.
Data monitoring will be performed and viewed by study personnel only. The data will be de-identified and a study number will be assigned to each patient. The patient's identity will be secured on a UTMB encrypted laptop device and a hard copy stored in the locked file cabinet in the locked office of the principal investigator.
Procedures to Maintain Confidentiality:
Data will be viewed by study personnel only. The data will then be de-identified and a study number will be assigned to each patient. The patient's identity will then be secured on a UTMB encrypted laptop device and a hard copy stored in the locked file cabinet in the locked office of the principal investigator.
Potential Benefits The potential benefits to subjects participating in the study include possible decreased neonatal morbidity and length of stay in the NICU.
Biostatistics Using data from the University of Texas Medical Branch (UTMB) on women with PPROM between 24 and 34 weeks, who fit the inclusion criteria, and who received the standard one course of betamethasone, the average length of stay in the NICU was 59.3 ± 36.3 days. The gestational age at delivery in this cohort was 26.5 ± 3.2 weeks.
Assuming that a second course of betamethasone reduces the length of stay needed in the NICU by 35%, and for a power of 80% and alpha 0.05, it is anticipated that enrollment of 49 women in each group will be needed, or 98 women total.
At UTMB, there are approximately 400 women per year hospitalized with PPROM. Assuming 50% of eligible women consent, the investigators estimate to finish recruitment for this study in 1-2 years.
Sample Size and Assumptions
- Frequency of primary outcome in control group (single course of betamethasone): is 59.3 days. The investigators assume a 35% reduction in length of NICU stay using two courses of betamethasone.
- α = 0.05, two sided
- β = 0.2
- Effect size: 35% reduction in primary outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betamethasone | Experimental | Drug: BetamethasoneWomen admitted with PPROM who will receive a second course of two betamethasone 12mg intramuscular (IM) injections given 24 hours apart. |
| Saline Placebo | Placebo comparator | Drug: PlaceboWomen admitted with PPROM who will receive intramuscular saline placebo, given as two injections 24 hours apart. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Maternal age ≥ 18 years
- Preterm premature rupture of membranes, demonstrated clinically by speculum exam
- Cervical dilation visually ≤ 5cm on sterile speculum exam
- Planned delivery at John Sealy Hospital (JSH)
- Gestational age of membrane rupture and initiation of first course of antenatal corticosteroids between 23 5/7 - 32 5/7 weeks
Key exclusion criteria (7 listed)
- Maternal age > 50 years
- Gestational age < 23 5/7 weeks or > 32 5/7 weeks
- Known major congenital abnormalities, aneuploidy, or genetic syndrome
- Intrauterine fetal demise
- Any indication for expedited delivery
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: CelestoneBetamethasone 12mg IM given every 24 hours for two doses | Drug | Betamethasone |
| PlaceboAlso: Saline placeboSterile 0.9% normal saline solution given IM every 24 hours for two doses | Drug | Saline Placebo |
Primary outcome
Average Number of Days in the Neonatal Intensive Care Unit (NICU)
Time frame: daily from birth of infant up to one year or discharge from the NICU, whichever occurred first
Mean number of days participants remained admitted to the Neonatal Intensive Care Unit (NICU) during hospitalization following birth.
7 secondary outcomes
Number of Participants With Composite Neonatal Morbidity
Time frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occured first
Average Number of Days Requiring Supplemental Oxygen or Ventilatory Support
Time frame: daily from birth until discharge from the NICU or up to 1 year of age, whichever occurred first.
Number of Participants Who Developed Respiratory Distress Syndrome (RDS)
Time frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first
Grade III or IV Intraventricular Hemorrhage (IVH)
Time frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first
Number of Participants With Neonatal Sepsis
Time frame: daily up to 72 hours of life
Number of Participants With Necrotizing Enterocolitis (NEC) Stage 2 or 3
Time frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first
Number of Perinatal Death(s)
Time frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25422655Atarod Z, Taghipour M, Roohanizadeh H, Fadavi S, Taghavipour M. Effects of single course and multicourse betamethasone prior to birth in the prognosis of the preterm neonates: A randomized, double-blind placebo-control clinical trial study. J Res Med Sci. 2014 Aug;19(8):715-9.
- Background: PubMed 25545441Brookfield KF, El-Sayed YY, Chao L, Berger V, Naqvi M, Butwick AJ. Antenatal corticosteroids for preterm premature rupture of membranes: single or repeat course? Am J Perinatol. 2015 May;32(6):537-44. doi: 10.1055/s-0034-1396690. Epub 2014 Dec 29.
- Background: PubMed 9932550Elimian A, Verma U, Canterino J, Shah J, Visintainer P, Tejani N. Effectiveness of antenatal steroids in obstetric subgroups. Obstet Gynecol. 1999 Feb;93(2):174-9. doi: 10.1016/s0029-7844(98)00400-1.
- Background: PubMed 10636498Elimian A, Verma U, Visintainer P, Tejani N. Effectiveness of multidose antenatal steroids. Obstet Gynecol. 2000 Jan;95(1):34-6. doi: 10.1016/s0029-7844(99)00471-8.
- Background: PubMed 25437730Gyamfi-Bannerman C, Son M. Preterm premature rupture of membranes and the rate of neonatal sepsis after two courses of antenatal corticosteroids. Obstet Gynecol. 2014 Nov;124(5):999-1003. doi: 10.1097/AOG.0000000000000460.
- Background: PubMed 18723909Mazumder P, Dutta S, Kaur J, Narang A. Single versus multiple courses of antenatal betamethasone and neonatal outcome: a randomized controlled trial. Indian Pediatr. 2008 Aug;45(8):661-7.
- Background: PubMed 11430973National Institutes of Health Consensus Development Panel. Antenatal corticosteroids revisited: repeat courses - National Institutes of Health Consensus Development Conference Statement, August 17-18, 2000. Obstet Gynecol. 2001 Jul;98(1):144-50. doi: 10.1016/s0029-7844(01)01410-7.
- Background: PubMed 24084566Practice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-930. doi: 10.1097/01.AOG.0000435415.21944.8f.
- Background: PubMed 11893433Wijnberger LD, Mostert JM, van Dam KI, Mol BW, Brouwers H, Visser GH. Comparison of single and repeated antenatal corticosteroid therapy to prevent neonatal death and morbidity in the preterm infant. Early Hum Dev. 2002 Apr;67(1-2):29-36. doi: 10.1016/s0378-3782(01)00248-1.
- Background: PubMed 15008385Yang SH, Choi SJ, Roh CR, Kim JH. Multiple courses of antenatal corticosteroid therapy in patients with preterm premature rupture of membranes. J Perinat Med. 2004;32(1):42-8. doi: 10.1515/JPM.2004.007.
- Individual participant dataSharing planned: No
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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.
Benjamin Bush, MD principal investigator
University of Texas Medical Branch in Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Betamethasone in people with PPROM and Respiratory Distress Syndrome in Premature Infants, run by The University of Texas Medical Branch, Galveston at 1 site 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Jun 2026. 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 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. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Number of Days in the Neonatal Intensive Care Unit (NICU) (time frame: daily from birth of infant up to one year or discharge from the NICU, whichever occurred first). 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 NCT02939742, which also lists 10 linked publications.
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 30 Jun 2026.