PPROMPROMOATNCT06906757
Preterm Rupture of Membranes Optimising Antibiotics Trial
A study testing Erythromycin 250mg and Amoxicillin 500mg in people with PPROM and Preterm, run by University of Melbourne.
Trial summary
The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes of babies born to pregnant women who have received these antibiotics. Read more about this study
- Who is it for?
- Any age, women only
- What is being tested?
- Erythromycin 250mg and Amoxicillin 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,900 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2050
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
PLATFORM ELIGIBILITY
Participants must meet all core PLATIPUS platform inclusion criteria:
- Considered to be at risk of birth before 37 weeks gestation (spontaneous and provider-initiated)
- Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and
- Meet eligibility criteria for one or more platform domains.
Participants will be excluded from participation if they meet any core PLATIPUS platform exclusion criteria:
- Inability to consent for themselves
- Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).
Pregnant women and people who meet ALL of the core platform inclusion criteria and none of the exclusion criteria will be considered for PROMOAT-specific eligibility.
PROMOAT-SPECIFIC ELIGIBILITY
Platform-eligible participants must meet all PROMOAT-specific inclusion criteria:
- Women with singleton or multiple pregnancies complicated by preterm prelabour rupture of membranes (PPROM) < 37+0 weeks' gestation as determined by the treating clinician and standard criteria:
- Maternal history consistent with loss of fluid per vagina
- Evidence of a pool of fluid in the vagina on sterile speculum examination
- +/- positive testing for IGFBP-1 (Actim PROM) or PAMG-1 (Amnisure) AND
- Are eligible for at least two treatment arms within the domain
- The fetus/fetuses are alive at randomisation
- The pregnancy is continuing and active neonatal management is planned.
Participants will be excluded from participation if they meet core PLATIPUS platform exclusion criteria:
- Inability to consent for themselves OR
- Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).
Participants will be excluded from participation if they meet any PROMOAT-specific exclusion criteria:
- Antibiotic treatment for > 24 hours administered with the aim of preventing infection from PPROM
- Suspected maternal or fetal infection (chorioamnionitis)
- Maternal or fetal indication for immediate birth
- Established preterm labour (cervical dilatation ≥ 3cm AND regular contractions)
- No appropriate antibiotic available within domain intervention arms due to allergy, contraindications, drug interactions, drug availability, or previous history of antibiotic-resistant infection/s
- Women with a previous infant affected by GBS sepsis
- Major congenital fetal anomaly.
Platform-eligible participants who meet all PROMOAT-specific inclusion criteria and none of the PROMOAT-specific exclusion criteria will be eligible to participate in PROMOAT.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preterm Rupture of Membranes Optimising Antibiotics Trial (PROMOAT). A Pregnancy Domain Within PLATIPUS.
The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes of babies born to pregnant women who have received these antibiotics.
PROMOAT aims to answer the question: Which antibiotic or combined antibiotic regimen most effectively prevents infection in pregnant women with PPROM < 37+0 weeks' gestation.
Read more
Researchers will compare three antibiotic regimens already used in clinical practice to prevent infection in pregnant women with PPROM.
Participants will be randomly allocated to the antibiotic regimen they will follow for seven days, or until birth (whichever is earlier). All antibiotics will be taken orally.
Neonatal health outcomes will be collected at 42 weeks postmenstrual age and maternal birth and postpartum care outcomes assessed at 42 days postpartum.
Questionnaires will capture maternal mood at time of consent and at 42 days postpartum. Antibiotic tolerance will be assessed at the time antibiotic treatment is ceased.
This trial will be undertaken as part of the PLATIPUS trial (NCT06461429).
Read the detailed description
PROMOAT aims to determine which of the most common antibiotic regimens are most effective in preventing infection in pregnant people with PPROM to improve health outcomes for their infants. PROMOAT is a pregnancy domain within the PLATIPUS adaptive platform trial (NCT06461429).
Preterm prelabour rupture of membranes (PPROM) precedes 30-40% of spontaneous preterm births and is an important cause of maternal and neonatal infection. Membrane rupture provides an entry point for microbes from the vagina to ascend into the uterine cavity, exposing the mother and the fetus to infectious pathogens leading to poor maternal and neonatal outcomes. Mothers with PPROM are at increased risk of haemorrhage, hysterectomy, sepsis, intensive care admission and death. Preterm infants exposed to in-utero infection are at higher risk of poor short- and long-term outcomes, including neonatal sepsis, neurodevelopmental delay, cerebral palsy, chronic lung disease and death.
Neonatal sepsis is the third most common cause of newborn deaths (~340,000 per year) and prevention is a major research priority, Neonatal sepsis due to pathogens acquired after PPROM may present in the first days of life and result in bacteraemia, pneumonia and meningitis. The most common pathogens associated with early-onset neonatal sepsis are Streptococcus agalactiae (aka Group B Streptococcus: GBS), Escherichia coli and Ureaplasma sp. Mortality is highest in the most immature infants, with a 54% case fatality rate in infants born before 24 weeks' gestation.
The goal in managing pregnancies complicated by PPROM is to prolong the pregnancy to enable fetal maturity without an increased risk of infection (acquired while the fetus remains in utero). Antibiotic prophylaxis has been shown to increase latency to birth but there is limited evidence to guide antibiotic choice to prevent infection in PPROM.
In PROMOAT, pregnant women with PPROM will be randomly assigned to receive one of the three intervention arms:
- Erythromycin
- Azithromycin, or
- Erythromycin and Amoxicillin.
Health outcomes will be assessed using the PLATIPUS Ordinal Outcome Scale, at 42 weeks' postmenstrual age or discharge home, whichever is earliest.
A short questionnaire at Day 7 (or birth, whichever is earlier) will measure compliance and antibiotic tolerance. A maternal and family health questionnaire will be collected at Day 42 postpartum.
- Being tested
- Erythromycin 250mg + placebo, Azithromycin 500mg + placebo, Erythromycin 250mg and Amoxicillin 500mg
- Keywords
- Pregnancy, Preterm, PPROM, Antibiotics, chorioamnionitis
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Premature Birth, Chorioamnionitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythromycin 250mg + placeboDrug
Antibiotic.
Azithromycin 500mg + placeboDrug
Antibiotic.
Erythromycin 250mg and Amoxicillin 500mgDrug
Antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin 250mg + placebo | Active comparator | Erythromycin 250mg, four times a day, for 7 days. Oral preparation only.
Placebo tablets instead of penicillin for blinding purposes. Receives: Drug: Erythromycin 250mg + placebo |
| Azithromycin 500mg + placebo | Active comparator | Azithromycin 500mg daily for 7 days. Oral preparation only.
Placebo tablets instead of penicillin for blinding purposes. Receives: Drug: Azithromycin 500mg + placebo |
| Erythromycin 250mg and Amoxicillin 500mg | Active comparator | Erythromycin 250mg, four times a day AND Amoxicillin 500mg three times a day, for 7 days. Oral preparations only. Receives: Drug: Erythromycin 250mg and Amoxicillin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who progress by at least one level higher on the PLATIPUS Ordinal Outcome Scale [PLATIPUS Core Primary Outcome]
The PLATIPUS-Ordinal Outcome Scale ranks the most severe core short-term infant health outcome in the specified time frame.
Levels 1-15: 1= Well, liveborn infant; 2= Neonatal unit admission for <48 hours; 3= Neonatal unit admission for >/= 48 hours; 4= Non-invasive respiratory support or oxygen therapy for ≥ 4 hours \& < 5 days; 5= Non-invasive respiratory support or oxygen therapy >/= 5 days; 6= Mechanical ventilation via endotracheal tube for ≥ 4 hours \& <7 days; 7= Mechanical ventilation via endotracheal tube for >/=7 days; 8= Moderate respiratory morbidity; 9=Necrotising enterocolitis AND/OR Sepsis; 10= Severe Respiratory Morbidity; 11= Major Surgery; 12= Brain Injury; 13= TWO of severe respiratory morbidity OR major surgery OR brain injury; 14= Severe respiratory morbidity \& major surgery \& brain injury; 15 = Death.
Measured: At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier).]
Secondary outcomes (8)
Time (randomisation) to birth
Number of days from randomisation to birth.
Measured: From randomisation to birth
Estimated antepartum/intrapartum/postpartum (< 24 hours) blood loss
Estimated antepartum/intrapartum/postpartum (<24 hours of birth) blood loss.
Measured: Less than 24 hours of birth.
Rate of clinical chorioamnionitis
Clinical chorioamnionitis Clinical suspicion of intra-amniotic infection such as: maternal fever (>/= 38C AND 2 of maternal tachycardia (> 100 beats/min), fetal tachycardia 26,27(> 160 beats/min), uterine tenderness, purulent/malodorous amniotic fluid, maternal leukocytosis (white blood cell count >/= 15,000/mm3) AND Antibiotics commenced for treatment for clinically suspected chorioamnionitis.
Measured: To birth.
Rate of histological chorioamnionitis/funisitis
Histological chorioamnionitis/funisitis
- Presence of inflammation in the placenta, chorion, umbilical cord and/or amnion with or without fetal inflammatory response defined according to staging of maternal (MIR) or fetal inflammatory response (FIR).
Measured: To birth
Rate of puerperal infection
Puerperal infection Infection of the maternal genital tract, urinary tract and wound infection from birth to day 42 postpartum AND Antibiotic treatment commenced
Measured: From birth to day 42 postpartum
Rate of early onset neonatal sepsis
Isolation of a bacterial or fungal organism from at least one of blood or CSF culture or by PCR sampled within 48 hours of birth AND after consideration of clinical and laboratory evidence, a decision is made to give the infant antibiotics with therapeutic intent against this organism for >5 days
Measured: Within 48 hours of birth.
Duration of neonatal antibiotic use commenced within 48 hours of birth.
Duration of neonatal antibiotic treatment commenced within 48 hours of birth.
Measured: Within 48 hours of birth.
Number of days of maternal antibiotic prescription after birth to day 42 postpartum
Estimated cumulative days of maternal antibiotic use from birth to day 42 postpartum
Measured: From birth to Day 42 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PPROMStudies 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
- Model description
- PROMOAT is a domain within the PLATIPUS adaptive platform trial (NCT06461429).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clare Whitehead, MBChB, PhD, Principal investigator, University of Melbourne and Royal Women's Hospital (Melbourne)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906757
- Sponsor's protocol ID
- P-P01-PROMOAT
- Acronym
- PROMOAT
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will align with PLATIPUS (NCT06461429) policy. Version 1, Apr-2024 Once data unblinding no longer compromises the integrity of the trial, a de-identified data set collected for the analysis of domains within PLATIPUS will be made available. Conditions 1. All domains in which the participant is co-enrolled are closed to recruitment\* (\*Where one or more domains in which a participant is co-enrolled are not yet closed to recruitment, the participant's data may be provided, without the treatment code, to prevent unblinding in unfinished domains). 2. Primary domain conclusions/analyses have been published, AND 3. The 2-year follow-up of participants within the domain/s of interest is/are complete. Supporting materials (Core Protocol, Domain-Specific Appendices, Data Dictionaries and Domain-Specific Statistical Analysis Plans) will be available. Contact: University of Melbourne - info@platipustrial.org.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Rupture of Membranes Optimising Antibiotics Trial (PROMOAT). A Pregnancy Domain Within PLATIPUS.
- ClinicalTrials.gov ID
- NCT06906757
- Acronym / sponsor ID
- PROMOAT / P-P01-PROMOAT
- Keywords
- Pregnancy, Preterm, PPROM, Antibiotics, chorioamnionitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,900 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 2 Apr 2025 (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.
The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes of babies born to pregnant women who have received these antibiotics.
PROMOAT aims to answer the question: Which antibiotic or combined antibiotic regimen most effectively prevents infection in pregnant women with PPROM < 37+0 weeks' gestation.
Researchers will compare three antibiotic regimens already used in clinical practice to prevent infection in pregnant women with PPROM.
Participants will be randomly allocated to the antibiotic regimen they will follow for seven days, or until birth (whichever is earlier). All antibiotics will be taken orally.
Neonatal health outcomes will be collected at 42 weeks postmenstrual age and maternal birth and postpartum care outcomes assessed at 42 days postpartum.
Questionnaires will capture maternal mood at time of consent and at 42 days postpartum. Antibiotic tolerance will be assessed at the time antibiotic treatment is ceased.
This trial will be undertaken as part of the PLATIPUS trial (NCT06461429).
Detailed description
PROMOAT aims to determine which of the most common antibiotic regimens are most effective in preventing infection in pregnant people with PPROM to improve health outcomes for their infants. PROMOAT is a pregnancy domain within the PLATIPUS adaptive platform trial (NCT06461429).
Preterm prelabour rupture of membranes (PPROM) precedes 30-40% of spontaneous preterm births and is an important cause of maternal and neonatal infection. Membrane rupture provides an entry point for microbes from the vagina to ascend into the uterine cavity, exposing the mother and the fetus to infectious pathogens leading to poor maternal and neonatal outcomes. Mothers with PPROM are at increased risk of haemorrhage, hysterectomy, sepsis, intensive care admission and death. Preterm infants exposed to in-utero infection are at higher risk of poor short- and long-term outcomes, including neonatal sepsis, neurodevelopmental delay, cerebral palsy, chronic lung disease and death.
Neonatal sepsis is the third most common cause of newborn deaths (~340,000 per year) and prevention is a major research priority, Neonatal sepsis due to pathogens acquired after PPROM may present in the first days of life and result in bacteraemia, pneumonia and meningitis. The most common pathogens associated with early-onset neonatal sepsis are Streptococcus agalactiae (aka Group B Streptococcus: GBS), Escherichia coli and Ureaplasma sp. Mortality is highest in the most immature infants, with a 54% case fatality rate in infants born before 24 weeks' gestation.
The goal in managing pregnancies complicated by PPROM is to prolong the pregnancy to enable fetal maturity without an increased risk of infection (acquired while the fetus remains in utero). Antibiotic prophylaxis has been shown to increase latency to birth but there is limited evidence to guide antibiotic choice to prevent infection in PPROM.
In PROMOAT, pregnant women with PPROM will be randomly assigned to receive one of the three intervention arms:
- Erythromycin
- Azithromycin, or
- Erythromycin and Amoxicillin.
Health outcomes will be assessed using the PLATIPUS Ordinal Outcome Scale, at 42 weeks' postmenstrual age or discharge home, whichever is earliest.
A short questionnaire at Day 7 (or birth, whichever is earlier) will measure compliance and antibiotic tolerance. A maternal and family health questionnaire will be collected at Day 42 postpartum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- PROMOAT is a domain within the PLATIPUS adaptive platform trial (NCT06461429).
| Arm | Type | Receives |
|---|---|---|
| Erythromycin 250mg + placebo | Active comparator | Drug: Erythromycin 250mg + placeboErythromycin 250mg, four times a day, for 7 days. Oral preparation only. Placebo tablets instead of penicillin for blinding purposes. |
| Azithromycin 500mg + placebo | Active comparator | Drug: Azithromycin 500mg + placeboAzithromycin 500mg daily for 7 days. Oral preparation only. Placebo tablets instead of penicillin for blinding purposes. |
| Erythromycin 250mg and Amoxicillin 500mg | Active comparator | Drug: Erythromycin 250mg and Amoxicillin 500mgErythromycin 250mg, four times a day AND Amoxicillin 500mg three times a day, for 7 days. Oral preparations only. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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 |
|---|---|---|
| Erythromycin 250mg + placeboAntibiotic. | Drug | Erythromycin 250mg + placebo |
| Azithromycin 500mg + placeboAntibiotic. | Drug | Azithromycin 500mg + placebo |
| Erythromycin 250mg and Amoxicillin 500mgAntibiotics. | Drug | Erythromycin 250mg and Amoxicillin 500mg |
Primary outcome
Number of participants who progress by at least one level higher on the PLATIPUS Ordinal Outcome Scale [PLATIPUS Core Primary Outcome]
Time frame: At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier).]
The PLATIPUS-Ordinal Outcome Scale ranks the most severe core short-term infant health outcome in the specified time frame. Levels 1-15: 1= Well, liveborn infant; 2= Neonatal unit admission for <48 hours; 3= Neonatal unit admission for >/= 48 hours; 4= Non-invasive respiratory support or oxygen therapy for ≥ 4 hours \& < 5 days; 5= Non-invasive respiratory support or oxygen therapy >/= 5 days; 6= Mechanical ventilation via endotracheal tube for ≥ 4 hours \& <7 days; 7= Mechanical ventilation via endotracheal tube for >/=7 days; 8= Moderate respiratory morbidity; 9=Necrotising enterocolitis AND/OR Sepsis; 10= Severe Respiratory Morbidity; 11= Major Surgery; 12= Brain Injury; 13= TWO of severe respiratory morbidity OR major surgery OR brain injury; 14= Severe respiratory morbidity \& major surgery \& brain injury; 15 = Death.
8 secondary outcomes
Time (randomisation) to birth
Time frame: From randomisation to birth
Estimated antepartum/intrapartum/postpartum (< 24 hours) blood loss
Time frame: Less than 24 hours of birth.
Rate of clinical chorioamnionitis
Time frame: To birth.
Rate of histological chorioamnionitis/funisitis
Time frame: To birth
Rate of puerperal infection
Time frame: From birth to day 42 postpartum
Rate of early onset neonatal sepsis
Time frame: Within 48 hours of birth.
Duration of neonatal antibiotic use commenced within 48 hours of birth.
Time frame: Within 48 hours of birth.
Number of days of maternal antibiotic prescription after birth to day 42 postpartum
Time frame: From birth to Day 42 postpartum
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 2 Apr 2025.
- Individual participant dataSharing planned: Yes. Data sharing will align with PLATIPUS (NCT06461429) policy. Version 1, Apr-2024 Once data unblinding no longer compromises the integrity of the trial, a de-identified data set collected for the analysis of domains within PLATIPUS will be made available. Conditions 1. All domains in which the participant is co-enrolled are closed to recruitment* (*Where one or more domains in which a participant is co-enrolled are not yet closed to recruitment, the participant's data may be provided, without the treatment code, to prevent unblinding in unfinished domains). 2. Primary domain conclusions/analyses have been published, AND 3. The 2-year follow-up of participants within the domain/s of interest is/are complete. Supporting materials (Core Protocol, Domain-Specific Appendices, Data Dictionaries and Domain-Specific Statistical Analysis Plans) will be available. Contact: University of Melbourne - info@platipustrial.org.
Related trials for PPROM
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Active, not recruitingPhase 3
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Premature Rupture of Membrane
Not yet recruitingObservational study
Preterm Parturation Study
Preterm Parturation, Preterm Premature Rupture of Membranes (PPROM)
Not yet recruitingObservational study
Prediction of Latency Interval in Patients With Preterm Prelabor Rupture of Membranes
Preterm Prelabor Rupture of Membranes (PPROM)
Recruiting
Effects of Emotional Freedom Technique and Music Therapy in High-Risk Pregnancy
Preterm Premature Rupture of Membranes (PPROM), Premature Rupture of Membranes (PROM)
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.
Clare Whitehead, MBChB, PhD principal investigator
University of Melbourne and Royal Women's Hospital (Melbourne)
Questions about this trial
What is this clinical trial studying?
A study testing Erythromycin 250mg and Amoxicillin 500mg in people with PPROM and Preterm, run by University of Melbourne.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Clare Whitehead, MBChB, PhD (00610383452000, clarew@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who progress by at least one level higher on the PLATIPUS Ordinal Outcome Scale [PLATIPUS Core Primary Outcome] (time frame: At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier).]). 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 2 Apr 2025.