<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/NCT01727609</url>
  </required_header>
  <id_info>
    <org_study_id>SIFT01</org_study_id>
    <nct_id>NCT01727609</nct_id>
  </id_info>
  <brief_title>Speed of Increasing Milk Feeds Trial</brief_title>
  <acronym>SIFT</acronym>
  <official_title>A Multi-centre Randomised Controlled Trial of Two Speeds of Daily Increment of Milk Feeding in Very Preterm or Very Low Birth Weight Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Survival of preterm infants has increased greatly over the years, so a major aim now is to&#xD;
      improve the long term outlook for these babies and to avoid serious complications. The way&#xD;
      babies are fed in early life affects short and long-term health and survival.&#xD;
&#xD;
      Because the bowels of preterm infants have not matured, they cannot digest large volumes of&#xD;
      milk feeds straight away. Until the gut matures, nutrition is provided by intravenous drip&#xD;
      while the amount of milk given is gradually increased over time. Increasing the amount of&#xD;
      milk rapidly may increase the risk of gut complications. Increasing the amount of milk given&#xD;
      more slowly means that intravenous nutrition is needed for longer; there is an associated&#xD;
      risk of infection proportional to the time the intravenous line is present in the bloodstream&#xD;
      of these infants. Despite the importance of milk feeding preterm infants, there have been few&#xD;
      studies to inform how best to balance these risks, and what the best way to increase feeds in&#xD;
      these infants is - this study sets out to address this missing information.&#xD;
&#xD;
      The study will compare two different speeds of milk feed increase, one 'faster' and one&#xD;
      'slower', both within rates currently used in United Kingdom neonatal units. The study aims&#xD;
      to find out if either speed of milk feed increase gives better outcomes for the infants.&#xD;
      Investigators will measure a variety of outcomes, such as survival without disability,&#xD;
      infection, bowel problems, growth and long-term physical and mental development, as well as&#xD;
      the impact on families and the National Health Service, including costs.&#xD;
&#xD;
      The study is being led by an established team of researchers who have run similar studies&#xD;
      before, and uses an established network of neonatal units that have taken part in previous&#xD;
      studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2013</start_date>
  <completion_date type="Actual">May 10, 2018</completion_date>
  <primary_completion_date type="Actual">May 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival without moderate or severe disability</measure>
    <time_frame>24 months of age corrected for prematurity</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival to discharge home</measure>
    <time_frame>Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of microbiologically-confirmed or clinically suspected late-onset invasive infection</measure>
    <time_frame>Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of necrotizing enterocolitis (Bell stage 2 or 3)</measure>
    <time_frame>Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time taken to reach full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)</measure>
    <time_frame>Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth (weight and head circumference) at hospital discharge</measure>
    <time_frame>Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.</time_frame>
    <description>Measured by weight and head circumference z-scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of parenteral feeding before hospital discharge</measure>
    <time_frame>Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of time in intensive care</measure>
    <time_frame>Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2804</enrollment>
  <condition>Premature Birth</condition>
  <condition>Late-onset Invasive Infection</condition>
  <condition>Necrotizing Enterocolitis</condition>
  <arm_group>
    <arm_group_label>Slower milk feed increment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Increase milk feeds by 18 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Faster milk feed increment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Increase milk feeds by 30 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Milk feed (breast milk or formula milk)</intervention_name>
    <arm_group_label>Faster milk feed increment</arm_group_label>
    <arm_group_label>Slower milk feed increment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age at birth &lt;32 weeks, or birth weight less than 1,500 g&#xD;
&#xD;
          -  Receiving ≤30 ml/kg/day of milk at randomisation&#xD;
&#xD;
          -  Written informed parental consent is obtained&#xD;
&#xD;
        To ensure the widest applicability to preterm infants across the United Kingdom, those&#xD;
        exclusively breast milk fed, formula milk fed, or receiving mixed feeds will be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with a severe congenital anomaly&#xD;
&#xD;
          -  Infants who, in the opinion of the treating clinician, have no realistic chance of&#xD;
             survival&#xD;
&#xD;
          -  Infants who are unlikely to be traceable for follow-up at 24 months of age corrected&#xD;
             for prematurity (for example, infants of non-United Kingdom residents)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>32 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jon Dorling, MBChB DCH MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, NS, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Maternity Hospital, Dublin</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 2</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Harvey Hospital</name>
      <address>
        <city>Ashford</city>
        <zip>TN24 0LZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Maternity Hospital, Belfast</name>
      <address>
        <city>Belfast</city>
        <zip>BT12 6BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Women's Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham City Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B18 7QH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Heartlands Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Royal Infirmary</name>
      <address>
        <city>Bradford</city>
        <zip>BD9 6RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southmead Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Michael's Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>S2 8EG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Peters Hospital</name>
      <address>
        <city>Chertsey</city>
        <zip>KT16 0PZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Countess of Chester Hospital</name>
      <address>
        <city>Chester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Coventry</name>
      <address>
        <city>Coventry</city>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leighton Hospital</name>
      <address>
        <city>Crewe</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derbyshire Children's Hospital</name>
      <address>
        <city>Derby</city>
        <zip>DE22 3NE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Infirmary of Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon and Exeter Hospital</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Royal Maternity Hospital, Glasgow</name>
      <address>
        <city>Glasgow</city>
        <zip>G31 2ER</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern General Hospital</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gloucestershire Royal Hosptial</name>
      <address>
        <city>Gloucester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calderdale Royal Hospital</name>
      <address>
        <city>Halifax</city>
        <zip>HX3 0PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hull Royal Infirmary</name>
      <address>
        <city>Hull</city>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kettering General Hospital</name>
      <address>
        <city>Kettering</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds General Infirmary</name>
      <address>
        <city>Leeds</city>
        <zip>LS1 3EX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James's University Hospital</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lincoln County Hospital</name>
      <address>
        <city>Lincoln</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altnagelvin Area Hospital</name>
      <address>
        <city>Londonderry</city>
        <zip>BT47 6SB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Hospital</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Cook University Hospital</name>
      <address>
        <city>Middlesbrough</city>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Infirmary</name>
      <address>
        <city>Newcastle</city>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northampton General Hospital</name>
      <address>
        <city>Northampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham City Hospital</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigavon Area Hospital</name>
      <address>
        <city>Portadown</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Alexandra Hospital, Portsmouth</name>
      <address>
        <city>Portsmouth</city>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Berkshire Hospital</name>
      <address>
        <city>Reading</city>
        <zip>RG1 5AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Hospital, Romford</name>
      <address>
        <city>Romford</city>
        <zip>RM7 0AG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessop Wing, Sheffield</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2SF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Shrewsbury Hospital</name>
      <address>
        <city>Shrewsbury</city>
        <zip>SY3 8XQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Anne Hospital, Southampton</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 5YA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of North Tees</name>
      <address>
        <city>Stockton on Tees</city>
        <zip>TS19 8PE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Stoke University Hospital</name>
      <address>
        <city>Stoke-on-Trent</city>
        <zip>ST4 6QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunderland Royal Hospital</name>
      <address>
        <city>Sunderland</city>
        <zip>SR4 7TP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's Mill Hospital</name>
      <address>
        <city>Sutton-in-Ashfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singleton Hospital</name>
      <address>
        <city>Swansea</city>
        <zip>SA2 8QA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Western Hospital, Swindon</name>
      <address>
        <city>Swindon</city>
        <zip>SN3 6BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Croydon University Hospital</name>
      <address>
        <city>Thornton Heath</city>
        <zip>CR7 7YE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospital</name>
      <address>
        <city>Truro</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arrowe Park Hospital, Wirral</name>
      <address>
        <city>Upton</city>
        <zip>CH49 5PE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinderfields General Hospital</name>
      <address>
        <city>Wakefield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Warrington Hospital</name>
      <address>
        <city>Warrington</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wishaw General Hospital</name>
      <address>
        <city>Wishaw</city>
        <zip>ML2 0DP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Worcestershire Royal Hospital</name>
      <address>
        <city>Worcester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Hospital</name>
      <address>
        <city>York</city>
        <zip>YO31 8HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>March 7, 2019</last_update_submitted>
  <last_update_submitted_qc>March 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Preterm</keyword>
  <keyword>Very low birth weight</keyword>
  <keyword>Feeding</keyword>
  <keyword>Enteral</keyword>
  <keyword>Milk</keyword>
  <keyword>Sepsis</keyword>
  <keyword>Necrotizing enterocolitis (NEC)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enterocolitis</mesh_term>
    <mesh_term>Enterocolitis, Necrotizing</mesh_term>
    <mesh_term>Premature Birth</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/NCT01727609
org study id: SIFT01
nct id: NCT01727609
lead sponsor: 
collaborator: 
has dmc: Yes
Survival of preterm infants has increased greatly over the years, so a major aim now is to
      improve the long term outlook for these babies and to avoid serious complications. The way
      babies are fed in early life affects short and long-term health and survival.

      Because the bowels of preterm infants have not matured, they cannot digest large volumes of
      milk feeds straight away. Until the gut matures, nutrition is provided by intravenous drip
      while the amount of milk given is gradually increased over time. Increasing the amount of
      milk rapidly may increase the risk of gut complications. Increasing the amount of milk given
      more slowly means that intravenous nutrition is needed for longer; there is an associated
      risk of infection proportional to the time the intravenous line is present in the bloodstream
      of these infants. Despite the importance of milk feeding preterm infants, there have been few
      studies to inform how best to balance these risks, and what the best way to increase feeds in
      these infants is - this study sets out to address this missing information.

      The study will compare two different speeds of milk feed increase, one 'faster' and one
      'slower', both within rates currently used in United Kingdom neonatal units. The study aims
      to find out if either speed of milk feed increase gives better outcomes for the infants.
      Investigators will measure a variety of outcomes, such as survival without disability,
      infection, bowel problems, growth and long-term physical and mental development, as well as
      the impact on families and the National Health Service, including costs.

      The study is being led by an established team of researchers who have run similar studies
      before, and uses an established network of neonatal units that have taken part in previous
      studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival without moderate or severe disability
time frame: 24 months of age corrected for prematurity
measure: Survival to discharge home
time frame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Incidence of microbiologically-confirmed or clinically suspected late-onset invasive infection
time frame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Incidence of necrotizing enterocolitis (Bell stage 2 or 3)
time frame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Time taken to reach full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)
time frame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Growth (weight and head circumference) at hospital discharge
time frame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
description: Measured by weight and head circumference z-scores
measure: Duration of parenteral feeding before hospital discharge
time frame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Length of time in intensive care
time frame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Length of hospital stay
time frame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
arm group label: Slower milk feed increment
arm group type: Active Comparator
description: Increase milk feeds by 18 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)
arm group label: Faster milk feed increment
arm group type: Experimental
description: Increase milk feeds by 30 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)
intervention type: Dietary Supplement
intervention name: Milk feed (breast milk or formula milk)
arm group label: Faster milk feed increment
arm group label: Slower milk feed increment
criteria: 
gender: All
minimum age: N/A
maximum age: 32 Weeks
healthy volunteers: No
last name: Jon Dorling, MBChB DCH MD
role: Principal Investigator
affiliation: Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, NS, Canada
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country: Ireland
country: United Kingdom
responsible party type: Sponsor
mesh term: Enterocolitis
mesh term: Enterocolitis, Necrotizing
mesh term: Premature Birth