<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02994849</url>
  </required_header>
  <id_info>
    <org_study_id>2016NEO87</org_study_id>
    <nct_id>NCT02994849</nct_id>
  </id_info>
  <brief_title>OPTI-Prem: Optimising Neonatal Service Provision for Preterm Babies Born Between 27 and 31 Weeks of Gestation in England</brief_title>
  <acronym>OPTI-Prem</acronym>
  <official_title>OPTI-Prem: Optimising Neonatal Service Provision for Preterm Babies Born Between 27 and 31 Weeks of Gestation in England Using National Data, Qualitative Research and Economic Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Royal Wolverhampton Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Leicester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Neonatal Data Analysis Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BLISS charity</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Royal Wolverhampton Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Premature babies, born several weeks before their due date, are often very ill in the first&#xD;
      weeks and months of life, compared with those born at full term. Because babies' brains and&#xD;
      bodies are still developing at this time, early birth puts them at increased risk of later&#xD;
      problems with health and development. It is important to do everything possible to try to&#xD;
      improve the overall health of these children. Not only will this help children and families,&#xD;
      but it will also help to understand the correct amount and type of care they will need from&#xD;
      the NHS in the future. At present, England has three types of neonatal units: Neonatal&#xD;
      Intensive care units (NICUs) that can care for the most sick and most premature babies, Local&#xD;
      Neonatal Units (LNUs) that generally care for slightly less sick babies, and Special Care&#xD;
      baby units (SCBU) that care for larger premature babies who are generally well, but need time&#xD;
      to grow and develop before going home.&#xD;
&#xD;
      For those premature babies born between 27 and 31 weeks of pregnancy, there is no information&#xD;
      on whether they benefit from being looked after in one type of unit or another. At present&#xD;
      there is no guidance, so these babies may be looked after in either LNUs or NICUs. Babies who&#xD;
      are born at this stage of pregnancy cannot be looked after in a SCBU and sometimes need to be&#xD;
      moved after birth to either a NICU or LNU. There are 84 LNUs and 45 NICUs in England. In&#xD;
      2014, about half of these babies were cared for in a NICU and half in a LNU. There is the&#xD;
      need to know whether babies born between 27 and 31 weeks are best cared for in a NICU or LNU&#xD;
      or if it does not matter.&#xD;
&#xD;
      The main things that control where a baby is born are where the mother has her antenatal&#xD;
      care, and where there is a cot available for the baby. A mother may have antenatal care in a&#xD;
      hospital that has a NICU, LNU or SCBU. Because it is difficult to predict which mother is&#xD;
      going to have her baby early, she cannot be directed, at the time of her choosing her&#xD;
      hospital for antenatal care, where to go to for care. There is uncertainty before birth which&#xD;
      baby is likely to require intensive care, but usually the less mature babies need more&#xD;
      intensive care.&#xD;
&#xD;
      In this study to find out where it is best to care for babies born at 27-31 weeks of&#xD;
      pregnancy, the study will look at which type of unit: a) leads to the best outcome for babies&#xD;
      born at each week of pregnancy in this range; b) is most cost-effective for families and the&#xD;
      NHS and c) best considers views and needs of parents and staff caring for babies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mixed methods, longitudinal study; 5 work streams, supported by a Parent Advisory Panel:&#xD;
&#xD;
      Work stream 1:Clinical Outcomes Study Using routinely collected data from the National&#xD;
      Neonatal Research Database (NNRD) for babies born at 27-31 weeks of gestation, admitted to&#xD;
      neonatal units in England 01/01/14-31/12/17.Estimates of differences in mortality and&#xD;
      specified morbidities between babies cared for in LNUs and NICUs will be obtained Data will&#xD;
      be linked to Hospital Episode Statistics (morbidity) and ONS(mortality) up to 1 year of age&#xD;
      for longer term outcomes.&#xD;
&#xD;
      Work stream 2:Types of clinical care provided Using NNRD, data from a unit questionnaire&#xD;
      (01/01/017-31/12/2017), and review of guidelines from neonatal units, variation in clinical&#xD;
      practice in 6 areas will be examined: medical/nurse staffing; policies/practice re&#xD;
      respiratory support; infection control, feeding and developmental care, discharge and length&#xD;
      of stay. Where appropriate, outcomes (mortality, chronic lung disease, central line sepsis,&#xD;
      receipt of breastmilk on discharge and length of stay in hospital) by week of gestational&#xD;
      age, will be analysed between units with similar practices.&#xD;
&#xD;
      Work stream 3:Economic analysis A cost-effectiveness study comparing costs and outcomes of&#xD;
      LNU versus NICU will be conducted.&#xD;
&#xD;
      Work stream 4:Ethnographic study with a representative group of parents and clinicians&#xD;
      Observations and interviews will be used to explore factors parents think should guide&#xD;
      decision making about place of care and how it happens in practice; clinicians'&#xD;
      perspectives/practices on decision making and place of care; impact on parents/families of&#xD;
      these decisions and subsequent change in care location; and how parents can best be supported&#xD;
      at this time. 40 cases from 2 networks [20 real-time, 20 retrospective] will be studied.&#xD;
&#xD;
      Workstream 5:&#xD;
&#xD;
      Once the results of the 4 work streams are analysed, and conclusions reached, a working group&#xD;
      will be set up in collaboration with BAPM to develop recommendations to be made available for&#xD;
      health service delivery planning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>1 year of age</time_frame>
  </primary_outcome>
  <enrollment type="Actual">4364</enrollment>
  <condition>Neonatal Diseases and Abnormalities</condition>
  <eligibility>
    <study_pop>
      <textblock>
        preterm babies born at 27-31 weeks&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  preterm babies born at 27-31 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tilly Pillay</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Royal Wolverhampton NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Royal Wolverhampton NHS Trust</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://bmjopen.bmj.com/content/12/6/e059428</url>
    <description>Citation</description>
  </link>
  <results_reference>
    <citation>Ismail AQT, Boyle EM, Pillay T; OptiPrem Study Group. The impact of level of neonatal care provision on outcomes for preterm babies born between 27 and 31 weeks of gestation, or with a birth weight between 1000 and 1500 g: a review of the literature. BMJ Paediatr Open. 2020 Mar 17;4(1):e000583. doi: 10.1136/bmjpo-2019-000583. eCollection 2020.</citation>
    <PMID>32232179</PMID>
  </results_reference>
  <results_reference>
    <citation>Cupit C, Paton A, Boyle E, Pillay T, Armstrong N; OPTI-PREM Study Team. Managerial thinking in neonatal care: a qualitative study of place of care decision-making for preterm babies born at 27-31 weeks gestation in England. BMJ Open. 2022 Jun 27;12(6):e059428. doi: 10.1136/bmjopen-2021-059428.</citation>
    <PMID>35760541</PMID>
  </results_reference>
  <results_reference>
    <citation>Pillay T, Modi N, Rivero-Arias O, Manktelow B, Seaton SE, Armstrong N, Draper ES, Dawson K, Paton A, Ismail AQT, Yang M, Boyle EM. Optimising neonatal service provision for preterm babies born between 27 and 31 weeks gestation in England (OPTI-PREM), using national data, qualitative research and economic analysis: a study protocol. BMJ Open. 2019 Aug 22;9(8):e029421. doi: 10.1136/bmjopen-2019-029421.</citation>
    <PMID>31444186</PMID>
  </results_reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>August 16, 2022</last_update_submitted>
  <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infant, Newborn, Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02994849
org study id: 2016NEO87
nct id: NCT02994849
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Premature babies, born several weeks before their due date, are often very ill in the first
      weeks and months of life, compared with those born at full term. Because babies' brains and
      bodies are still developing at this time, early birth puts them at increased risk of later
      problems with health and development. It is important to do everything possible to try to
      improve the overall health of these children. Not only will this help children and families,
      but it will also help to understand the correct amount and type of care they will need from
      the NHS in the future. At present, England has three types of neonatal units: Neonatal
      Intensive care units (NICUs) that can care for the most sick and most premature babies, Local
      Neonatal Units (LNUs) that generally care for slightly less sick babies, and Special Care
      baby units (SCBU) that care for larger premature babies who are generally well, but need time
      to grow and develop before going home.

      For those premature babies born between 27 and 31 weeks of pregnancy, there is no information
      on whether they benefit from being looked after in one type of unit or another. At present
      there is no guidance, so these babies may be looked after in either LNUs or NICUs. Babies who
      are born at this stage of pregnancy cannot be looked after in a SCBU and sometimes need to be
      moved after birth to either a NICU or LNU. There are 84 LNUs and 45 NICUs in England. In
      2014, about half of these babies were cared for in a NICU and half in a LNU. There is the
      need to know whether babies born between 27 and 31 weeks are best cared for in a NICU or LNU
      or if it does not matter.

      The main things that control where a baby is born are where the mother has her antenatal
      care, and where there is a cot available for the baby. A mother may have antenatal care in a
      hospital that has a NICU, LNU or SCBU. Because it is difficult to predict which mother is
      going to have her baby early, she cannot be directed, at the time of her choosing her
      hospital for antenatal care, where to go to for care. There is uncertainty before birth which
      baby is likely to require intensive care, but usually the less mature babies need more
      intensive care.

      In this study to find out where it is best to care for babies born at 27-31 weeks of
      pregnancy, the study will look at which type of unit: a) leads to the best outcome for babies
      born at each week of pregnancy in this range; b) is most cost-effective for families and the
      NHS and c) best considers views and needs of parents and staff caring for babies.
Mixed methods, longitudinal study; 5 work streams, supported by a Parent Advisory Panel:

      Work stream 1:Clinical Outcomes Study Using routinely collected data from the National
      Neonatal Research Database (NNRD) for babies born at 27-31 weeks of gestation, admitted to
      neonatal units in England 01/01/14-31/12/17.Estimates of differences in mortality and
      specified morbidities between babies cared for in LNUs and NICUs will be obtained Data will
      be linked to Hospital Episode Statistics (morbidity) and ONS(mortality) up to 1 year of age
      for longer term outcomes.

      Work stream 2:Types of clinical care provided Using NNRD, data from a unit questionnaire
      (01/01/017-31/12/2017), and review of guidelines from neonatal units, variation in clinical
      practice in 6 areas will be examined: medical/nurse staffing; policies/practice re
      respiratory support; infection control, feeding and developmental care, discharge and length
      of stay. Where appropriate, outcomes (mortality, chronic lung disease, central line sepsis,
      receipt of breastmilk on discharge and length of stay in hospital) by week of gestational
      age, will be analysed between units with similar practices.

      Work stream 3:Economic analysis A cost-effectiveness study comparing costs and outcomes of
      LNU versus NICU will be conducted.

      Work stream 4:Ethnographic study with a representative group of parents and clinicians
      Observations and interviews will be used to explore factors parents think should guide
      decision making about place of care and how it happens in practice; clinicians'
      perspectives/practices on decision making and place of care; impact on parents/families of
      these decisions and subsequent change in care location; and how parents can best be supported
      at this time. 40 cases from 2 networks [20 real-time, 20 retrospective] will be studied.

      Workstream 5:

      Once the results of the 4 work streams are analysed, and conclusions reached, a working group
      will be set up in collaboration with BAPM to develop recommendations to be made available for
      health service delivery planning.
observational model: Cohort
time perspective: Other
measure: Survival
time frame: 1 year of age
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Year
healthy volunteers: No
last name: Tilly Pillay
role: Principal Investigator
affiliation: The Royal Wolverhampton NHS Trust
facility: 
country: United Kingdom
url: https://bmjopen.bmj.com/content/12/6/e059428
description: Citation
citation: Ismail AQT, Boyle EM, Pillay T; OptiPrem Study Group. The impact of level of neonatal care provision on outcomes for preterm babies born between 27 and 31 weeks of gestation, or with a birth weight between 1000 and 1500 g: a review of the literature. BMJ Paediatr Open. 2020 Mar 17;4(1):e000583. doi: 10.1136/bmjpo-2019-000583. eCollection 2020.
PMID: 32232179
citation: Cupit C, Paton A, Boyle E, Pillay T, Armstrong N; OPTI-PREM Study Team. Managerial thinking in neonatal care: a qualitative study of place of care decision-making for preterm babies born at 27-31 weeks gestation in England. BMJ Open. 2022 Jun 27;12(6):e059428. doi: 10.1136/bmjopen-2021-059428.
PMID: 35760541
citation: Pillay T, Modi N, Rivero-Arias O, Manktelow B, Seaton SE, Armstrong N, Draper ES, Dawson K, Paton A, Ismail AQT, Yang M, Boyle EM. Optimising neonatal service provision for preterm babies born between 27 and 31 weeks gestation in England (OPTI-PREM), using national data, qualitative research and economic analysis: a study protocol. BMJ Open. 2019 Aug 22;9(8):e029421. doi: 10.1136/bmjopen-2019-029421.
PMID: 31444186
responsible party type: Sponsor
mesh term: Infant, Newborn, Diseases