Preterm BirthNCT03151330
Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls: AVERT PRETERM TRIAL
A study testing Screened Arm in people with Preterm Birth, run by Christiana Care Health Services at 1 site in United States.
Trial summary
Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world. Recently treatments early in pregnancy such as progesterone, cervical support and maternal support have been demonstrated to delay delivery amongst at risk women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Screened Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,873 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 1 Jun 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women 18 years of age or older
- Singleton intrauterine pregnancy
- No medical contraindications to continuing pregnancy
- Subject has no signs and/or symptoms of preterm labor and has intact membranes
- Planned delivery at Christiana Care Health System,
- English speaking as consents from other languages will not be provided.
Who cannot join
- Women who have taken or plan to take progesterone beyond 14weeks gestation prior to study enrollment
- Previous history of sPTB less than37 weeks gestation or PPROM less than34 weeks gestation
- Multiple gestations-including a pregnancy that is now a single fetus due to a reduction procedure, vanishing twin, etc
- Known fetal genetic anomalies that are incompatible with life. Examples would include trisomy 13 and trisomy 18. Others would be left to the discretion of the site investigators
- Any other medical conditions that may be considered a contraindication per the judgment of the site investigator
- The subject has a planned cesarean section or induction of labor prior to 370/7 weeks of gestation
Show all 14Show fewer
- The subject has a planned cerclage placement for the current pregnancy
- Major structural anomalies that may shorten pregnancy- examples would include anencephaly, holoprosencephaly, schizencephaly, gastroschisis, omphalocele, congenital diaphragmatic hernia, pyloric stenosis, etc. Minor anomalies such as polydactyly, unilateral hydronephrosis are not viewed as exclusions. Others would be left to the discretion of the site investigators
- History of cervical conization
- The subject has a uterine anomaly, History of classical cesarean section in a previous pregnancy
- The subject has had a blood transfusion during the current pregnancy
- The subject has known elevated bilirubin levels (hyperbilirubinemia)
- Previously identified short cervix (< 2.5 cm by TVUS)
- The subject has taken or plans to take any of the following medications after the first day of the last menstrual period: Enoxaparin, heparin, heparin sodium, low molecular weight heparin or the subject has a history of allergic reaction to aspirin or progesterone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Assessment of Preterm Birth: Outcomes Compared to Historical Controls
Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world. Recently treatments early in pregnancy such as progesterone, cervical support and maternal support have been demonstrated to delay delivery amongst at risk women. Nonetheless, the majority of women who are at risk are not identified using current screening modalities.
Hypothesis: A cohort of pregnancies who are screened using the PreTRM® test around 20 weeks gestation in which a bundle of interventions is given for elevated PreTRM® risk will show either decreased neonatal morbidity/and mortality (measured as a composite score, "NMI"), or decreased length of neonatal stay in the hospital (NNOLOS). Secondarily, they will show an increase in gestational age at birth (GAB) and a reduction in length of neonatal NICU stay (NICULOS), compared to an unscreened historical control group.
Study Design Type: Prospective cohort study of screened women compared to a historical control of 10000 women.
Read the detailed description
Population: Women who are 18 years or older, with a singleton pregnancy between 195/7 weeks and 206/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, and no history of prior preterm birth (delivery between 160/7 weeks and 366/7 weeks) will be invited to participate. A comparable population will be identified using a historical control group in a contemporaneously maintained database.
Intervention: Qualifying women will be screened using the PreTRM® test (Sera Prognostics, Inc.) at a large tertiary care center. Predicated upon the degree of risk, women will be treated according to a prespecified algorithm. The outcomes of these women will be compared to a historical control group at the same tertiary care center.
Outcomes:
Primary outcome: Co-Primary outcomes: To determine whether a cohort of women who are screened with the PreTRM® test and then managed according to a prespecified protocol will have statistically significant reductions in either (a) composite neonatal morbidity and mortality (NMI score), or (b) length of neonatal hospital stay (NNOLOS), compared to a historical control group. The NMI is defined below
DEFINITIONS OF COMPOSITE PERINATAL MORTALITY/NEONATAL MORBIDITY OUTCOME SCORES:
- 0 to 4 scale without NICU: This score was derived as an ordinal scale based upon severity. The score was defined by the following: 0 = no events;
- = one event for (RDS, BPD, grade III or IV IVH, PVL, proven sepsis, or NEC) and no perinatal mortality,
- = two events and no perinatal mortality;
- = three or more events and no perinatal mortality; 4=perinatal mortality.
- 0 to 4 scale with NICU: This score was defined as the following: 0 = no events,
- = one event for (RDS, BPD, grade III or IV IVH, PVL, proven sepsis, or NEC) or <5 days in the NICU, and no perinatal mortality;
- = two events or between 5 and 20 days in the NICU, and no perinatal mortality;
- = three or more events or >20 days in the NICU, and no perinatal mortality;
- = perinatal mortality.
- 0 to 6 scale without NICU: This score was defined as the following: 0 = no events;
- = one event for (RDS, BPD, grade III or IV IVH, proven sepsis, or NEC) and no perinatal mortality,
- = two events and no perinatal mortality;
- = three events and no perinatal mortality;
- = four events and no perinatal mortality;
- = five events and no perinatal mortality;
- = perinatal mortality.
- Any morbidity or mortality event: (yes/no)
- Adapted from Hassan SS, et al. Ultrasound Obstet Gynecol 2011; 38:18-31 Supplementary Information
Secondary outcomes: To determine whether women who are screened with the PreTRM® test and then managed according to a pre-specified treatment algorithm will have a statistically significant reduction in proportion of any type of preterm births (spontaneous and indicated), the total length of hospital stay for spontaneous preterm births, and total length of hospital stay for any preterm birth.
Observations:
- Neonatal death and stillbirth
- Birth weight and number of subjects with birth weight <1500g and <2500g
- Total number of days spent in the NICU and nursery
- Composite neonatal morbidity score and components
- Whether or not received surfactant
- Occurrence of pneumonia
- Number of days of mechanical ventilation
- Number of subjects with 5 minute Apgar < 7
- Occurrence of asphyxia
- Number of preterm deliveries at <37, <35 and <32 weeks
- Occurrence of preeclampsia
- Proportion of primiparous women experiencing preterm birth and spontaneous preterm birth
- NICU days for spontaneous preterm birth in primiparous women in prospective treatment arm are significantly less than NICU days in primiparous women in the control group of sPTB
- Correlation of blood levels of 17-OHPC and other progestin levels to outcomes and observations
General Outcomes:
Total cost of hospital care for both the mother and fetus beginning at initiation of care through primary delivery and 28 days of life.
- Conditions
- Preterm Birth
- Being tested
- Screened Arm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screened ArmOther
Woman who are identified as high risk will be advised of potential interventions which will include support through care link(nurse education), cervical surveillance, consider vaginal progesterone, low dose aspirin if not already taking.
| Study group | Role | What they receive |
|---|---|---|
| Screened arm | Other | This will be an arm of women who are prospectively screened and receive a risk score for preterm birth. They will be recommended treatment strategies and their outcomes compared to an historical control. Receives: Other: Screened Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Mortality Index
Outcomes:
Co primary outcomes will consist of the Neonatal Morbidity Index as defined by Hassan and Neonatal NICU length of stay
Measured: Birth through 6 months
Neonatal NICU length of stay
Duration of hospitalization in the NICU
Measured: Birth to 6 months
Secondary outcomes (2)
Preterm birth
Preterm birth before 37 weeks
Measured: Through pregnancy completion, typically 42 weeks
Total length of hospital stay for any preterm birth
Total length of hospital stay for any preterm birth
Measured: From birth to 60 days post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start15 Jun 2018
- Primary completion16 Mar 2020
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Women who are found to have an elevated risk of preterm birth will receive counseling regarding potential interventions and compared to historical controls
- Masking
- None (open label)
- Enrolment
- 1,873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Hoffman, Christiana Care Health Services
- Investigators
- Matthew K Hoffman, MD, Principal investigator, ChristianaCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151330
- Sponsor's protocol ID
- DDD603819
- Status last verified
- Aug 2024
- First submitted
- 22 Apr 2017
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will potentially be shared with a like study being conducted at the University of Utah
Publications
Anderson RN, Smith BL. Deaths: leading causes for 2001. Natl Vital Stat Rep. 2003 Nov 7;52(9):1-85.
PubMed 14626726Berghella V, Rafael TJ, Szychowski JM, Rust OA, Owen J. Cerclage for short cervix on ultrasonography in women with singleton gestations and previous preterm birth: a meta-analysis. Obstet Gynecol. 2011 Mar;117(3):663-671. doi: 10.1097/AOG.0b013e31820ca847.
PubMed 21446209CLASP: a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group. Lancet. 1994 Mar 12;343(8898):619-29.
PubMed 7906809Esplin MS, Elovitz MA, Iams JD, Parker CB, Wapner RJ, Grobman WA, Simhan HN, Wing DA, Haas DM, Silver RM, Hoffman MK, Peaceman AM, Caritis SN, Parry S, Wadhwa P, Foroud T, Mercer BM, Hunter SM, Saade GR, Reddy UM; nuMoM2b Network. Predictive Accuracy of Serial Transvaginal Cervical Lengths and Quantitative Vaginal Fetal Fibronectin Levels for Spontaneous Preterm Birth Among Nulliparous Women. JAMA. 2017 Mar 14;317(10):1047-1056. doi: 10.1001/jama.2017.1373.
PubMed 28291893Rittenberg C, Newman RB, Istwan NB, Rhea DJ, Stanziano GJ. Preterm birth prevention by 17 alpha-hydroxyprogesterone caproate vs. daily nursing surveillance. J Reprod Med. 2009 Feb;54(2):47-52.
PubMed 19301566Saade GR, Boggess KA, Sullivan SA, Markenson GR, Iams JD, Coonrod DV, Pereira LM, Esplin MS, Cousins LM, Lam GK, Hoffman MK, Severinsen RD, Pugmire T, Flick JS, Fox AC, Lueth AJ, Rust SR, Mazzola E, Hsu C, Dufford MT, Bradford CL, Ichetovkin IE, Fleischer TC, Polpitiya AD, Critchfield GC, Kearney PE, Boniface JJ, Hickok DE. Development and validation of a spontaneous preterm delivery predictor in asymptomatic women. Am J Obstet Gynecol. 2016 May;214(5):633.e1-633.e24. doi: 10.1016/j.ajog.2016.02.001. Epub 2016 Feb 11.
PubMed 26874297Romero R, Conde-Agudelo A, El-Refaie W, Rode L, Brizot ML, Cetingoz E, Serra V, Da Fonseca E, Abdelhafez MS, Tabor A, Perales A, Hassan SS, Nicolaides KH. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. Ultrasound Obstet Gynecol. 2017 Mar;49(3):303-314. doi: 10.1002/uog.17397.
PubMed 28067007
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Assessment of Preterm Birth: Outcomes Compared to Historical Controls
- ClinicalTrials.gov ID
- NCT03151330
- Acronym / sponsor ID
- DDD603819
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,873 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 12 May 2017 (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.
Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world. Recently treatments early in pregnancy such as progesterone, cervical support and maternal support have been demonstrated to delay delivery amongst at risk women. Nonetheless, the majority of women who are at risk are not identified using current screening modalities.
Hypothesis: A cohort of pregnancies who are screened using the PreTRM® test around 20 weeks gestation in which a bundle of interventions is given for elevated PreTRM® risk will show either decreased neonatal morbidity/and mortality (measured as a composite score, "NMI"), or decreased length of neonatal stay in the hospital (NNOLOS). Secondarily, they will show an increase in gestational age at birth (GAB) and a reduction in length of neonatal NICU stay (NICULOS), compared to an unscreened historical control group.
Study Design Type: Prospective cohort study of screened women compared to a historical control of 10000 women.
Detailed description
Population: Women who are 18 years or older, with a singleton pregnancy between 195/7 weeks and 206/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, and no history of prior preterm birth (delivery between 160/7 weeks and 366/7 weeks) will be invited to participate. A comparable population will be identified using a historical control group in a contemporaneously maintained database.
Intervention: Qualifying women will be screened using the PreTRM® test (Sera Prognostics, Inc.) at a large tertiary care center. Predicated upon the degree of risk, women will be treated according to a prespecified algorithm. The outcomes of these women will be compared to a historical control group at the same tertiary care center.
Outcomes:
Primary outcome: Co-Primary outcomes: To determine whether a cohort of women who are screened with the PreTRM® test and then managed according to a prespecified protocol will have statistically significant reductions in either (a) composite neonatal morbidity and mortality (NMI score), or (b) length of neonatal hospital stay (NNOLOS), compared to a historical control group. The NMI is defined below
DEFINITIONS OF COMPOSITE PERINATAL MORTALITY/NEONATAL MORBIDITY OUTCOME SCORES:
- 0 to 4 scale without NICU: This score was derived as an ordinal scale based upon severity. The score was defined by the following: 0 = no events;
- = one event for (RDS, BPD, grade III or IV IVH, PVL, proven sepsis, or NEC) and no perinatal mortality,
- = two events and no perinatal mortality;
- = three or more events and no perinatal mortality; 4=perinatal mortality.
- 0 to 4 scale with NICU: This score was defined as the following: 0 = no events,
- = one event for (RDS, BPD, grade III or IV IVH, PVL, proven sepsis, or NEC) or <5 days in the NICU, and no perinatal mortality;
- = two events or between 5 and 20 days in the NICU, and no perinatal mortality;
- = three or more events or >20 days in the NICU, and no perinatal mortality;
- = perinatal mortality.
- 0 to 6 scale without NICU: This score was defined as the following: 0 = no events;
- = one event for (RDS, BPD, grade III or IV IVH, proven sepsis, or NEC) and no perinatal mortality,
- = two events and no perinatal mortality;
- = three events and no perinatal mortality;
- = four events and no perinatal mortality;
- = five events and no perinatal mortality;
- = perinatal mortality.
- Any morbidity or mortality event: (yes/no)
- Adapted from Hassan SS, et al. Ultrasound Obstet Gynecol 2011; 38:18-31 Supplementary Information
Secondary outcomes: To determine whether women who are screened with the PreTRM® test and then managed according to a pre-specified treatment algorithm will have a statistically significant reduction in proportion of any type of preterm births (spontaneous and indicated), the total length of hospital stay for spontaneous preterm births, and total length of hospital stay for any preterm birth.
Observations:
- Neonatal death and stillbirth
- Birth weight and number of subjects with birth weight <1500g and <2500g
- Total number of days spent in the NICU and nursery
- Composite neonatal morbidity score and components
- Whether or not received surfactant
- Occurrence of pneumonia
- Number of days of mechanical ventilation
- Number of subjects with 5 minute Apgar < 7
- Occurrence of asphyxia
- Number of preterm deliveries at <37, <35 and <32 weeks
- Occurrence of preeclampsia
- Proportion of primiparous women experiencing preterm birth and spontaneous preterm birth
- NICU days for spontaneous preterm birth in primiparous women in prospective treatment arm are significantly less than NICU days in primiparous women in the control group of sPTB
- Correlation of blood levels of 17-OHPC and other progestin levels to outcomes and observations
General Outcomes:
Total cost of hospital care for both the mother and fetus beginning at initiation of care through primary delivery and 28 days of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Women who are found to have an elevated risk of preterm birth will receive counseling regarding potential interventions and compared to historical controls
| Arm | Type | Receives |
|---|---|---|
| Screened arm | Other | Other: Screened ArmThis will be an arm of women who are prospectively screened and receive a risk score for preterm birth. They will be recommended treatment strategies and their outcomes compared to an historical control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women 18 years of age or older
- Singleton intrauterine pregnancy
- No medical contraindications to continuing pregnancy
- Subject has no signs and/or symptoms of preterm labor and has intact membranes
- Planned delivery at Christiana Care Health System,
Key exclusion criteria (14 listed)
- Women who have taken or plan to take progesterone beyond 14weeks gestation prior to study enrollment
- Previous history of sPTB less than37 weeks gestation or PPROM less than34 weeks gestation
- Multiple gestations-including a pregnancy that is now a single fetus due to a reduction procedure, vanishing twin, etc
- Known fetal genetic anomalies that are incompatible with life. Examples would include trisomy 13 and trisomy 18. Others would be left to the discretion of the site investigators
- Any other medical conditions that may be considered a contraindication per the judgment of the site investigator
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 |
|---|---|---|
| Screened ArmWoman who are identified as high risk will be advised of potential interventions which will include support through care link(nurse education), cervical surveillance, consider vaginal progesterone, low dose aspirin if not already taking. | Other | Screened arm |
Primary outcome
Neonatal Mortality Index
Time frame: Birth through 6 months
Outcomes: Co primary outcomes will consist of the Neonatal Morbidity Index as defined by Hassan and Neonatal NICU length of stay
Neonatal NICU length of stay
Time frame: Birth to 6 months
Duration of hospitalization in the NICU
2 secondary outcomes
Preterm birth
Time frame: Through pregnancy completion, typically 42 weeks
Total length of hospital stay for any preterm birth
Time frame: From birth to 60 days post delivery
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 5 Aug 2024.
- Background: PubMed 14626726Anderson RN, Smith BL. Deaths: leading causes for 2001. Natl Vital Stat Rep. 2003 Nov 7;52(9):1-85.
- Background: PubMed 21446209Berghella V, Rafael TJ, Szychowski JM, Rust OA, Owen J. Cerclage for short cervix on ultrasonography in women with singleton gestations and previous preterm birth: a meta-analysis. Obstet Gynecol. 2011 Mar;117(3):663-671. doi: 10.1097/AOG.0b013e31820ca847.
- Background: PubMed 7906809CLASP: a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group. Lancet. 1994 Mar 12;343(8898):619-29.
- Background: PubMed 28291893Esplin MS, Elovitz MA, Iams JD, Parker CB, Wapner RJ, Grobman WA, Simhan HN, Wing DA, Haas DM, Silver RM, Hoffman MK, Peaceman AM, Caritis SN, Parry S, Wadhwa P, Foroud T, Mercer BM, Hunter SM, Saade GR, Reddy UM; nuMoM2b Network. Predictive Accuracy of Serial Transvaginal Cervical Lengths and Quantitative Vaginal Fetal Fibronectin Levels for Spontaneous Preterm Birth Among Nulliparous Women. JAMA. 2017 Mar 14;317(10):1047-1056. doi: 10.1001/jama.2017.1373.
- Background: PubMed 19301566Rittenberg C, Newman RB, Istwan NB, Rhea DJ, Stanziano GJ. Preterm birth prevention by 17 alpha-hydroxyprogesterone caproate vs. daily nursing surveillance. J Reprod Med. 2009 Feb;54(2):47-52.
- Background: PubMed 26874297Saade GR, Boggess KA, Sullivan SA, Markenson GR, Iams JD, Coonrod DV, Pereira LM, Esplin MS, Cousins LM, Lam GK, Hoffman MK, Severinsen RD, Pugmire T, Flick JS, Fox AC, Lueth AJ, Rust SR, Mazzola E, Hsu C, Dufford MT, Bradford CL, Ichetovkin IE, Fleischer TC, Polpitiya AD, Critchfield GC, Kearney PE, Boniface JJ, Hickok DE. Development and validation of a spontaneous preterm delivery predictor in asymptomatic women. Am J Obstet Gynecol. 2016 May;214(5):633.e1-633.e24. doi: 10.1016/j.ajog.2016.02.001. Epub 2016 Feb 11.
- Background: PubMed 28067007Romero R, Conde-Agudelo A, El-Refaie W, Rode L, Brizot ML, Cetingoz E, Serra V, Da Fonseca E, Abdelhafez MS, Tabor A, Perales A, Hassan SS, Nicolaides KH. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. Ultrasound Obstet Gynecol. 2017 Mar;49(3):303-314. doi: 10.1002/uog.17397.
- Individual participant dataSharing planned: Yes. IPD will potentially be shared with a like study being conducted at the University of Utah
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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.
Matthew K Hoffman, MD principal investigator
ChristianaCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screened Arm in people with Preterm Birth, run by Christiana Care Health Services 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 14 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 5 Aug 2024. 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. 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 Mortality Index (time frame: Birth through 6 months). The study lists 2 primary outcomes in all. 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 NCT03151330, which also lists 7 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 5 Aug 2024.