<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190228042868N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-25</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigating Prognosis of Early Feeding with Breast milk-Cells in Premature infants</public_title>
      <acronym></acronym>
      <scientific_title>Investigating Prognosis of Early Feeding with Breast milk-Cells in Premature infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38230</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to statistical method : Block randomization, Blinding description: We urge the mothers of both groups to express their own milk.This action will stimulate and secrete more milk for mothers in the coming days and is recommended.
Because the low-birth weight infants can not tolerate feeding in routine therapy, the extracted cells are given to the case group. As time goes on, nutrition will be started for both groups, based on the routine (clinical and special condition).</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Necrotizing enterocolitis (NEC). Condition 2: Bacterial sepsis of newborn. Condition 3: Retinopathy of prematurity. Condition 4: Bronchopulmonary dysplasia.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, feeding with lactating cells started by separating  of the fat and protein layer. these neonate can not tolerate whole breast milk. Intervention 2: Control group: Babies who received routine nursing care and  after a few days breastfeeding will be started.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All individual data will be available after the publication of the article, after making the participants identifiable.

When:
Immediately after publication.

To whom:
It will be available for all researchers.

Conditions:
To promote breastfeeding and the importance of the compounds and cells in it.

Where to obtain:
Requests sent to the author's e-mail or other corresponders will be answered as soon as possible.

How to obtain:
Simple request sent to the corresponding author's email.

Comments:
Since one of our goals is promoting breastfeeding, we will do our best to publish our findings.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shafiee Rodsari Mohammad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neonatal Health Research Center-Mofid Children Hospital - Shariati Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1546815514</zip>
        <telephone>+98 21 2292 2827</telephone>
        <email>leilashsh@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kazemianm Mohammad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neonatal Health Research Center-Mofid Children Hospital - Shariati Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1546815514</zip>
        <telephone>+98 21 2292 2827</telephone>
        <email>Kazemianm@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All the neonates that were born with a birth weight less than 1800 grams</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>90 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parental dissatisfaction with the implementation of this study
Failure to prepare breast milk for various reasons
Congenital severe anomalies
The presence of any serious and fatal illness that is in conflict with life
Severe Prematurity (less than 25 weeks)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P77</hc_code>
      <hc_code>P36</hc_code>
      <hc_code>H35.1</hc_code>
      <hc_code>P27.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Necrotizing enterocolitis of newborn</hc_keyword>
      <hc_keyword>Bacterial sepsis of newborn</hc_keyword>
      <hc_keyword>Retinopathy of prematurity</hc_keyword>
      <hc_keyword>Bronchopulmonary dysplasia originating in the perinatal period</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, feeding with lactating cells started by separating  of the fat and protein layer. these neonate can not tolerate whole breast milk.</i_keyword>
      <i_keyword>Control group: Babies who received routine nursing care and  after a few days breastfeeding will be started.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of hospital stay. Timepoint: The whole period of admission is evaluated. Method of measurement: Based on observation and examination and questionnaire records.</prim_outcome>
      <prim_outcome>2-Comparison of the total feeding time in the newborn. Timepoint: From birth to full feeding. Method of measurement: Evidence available in the clinical file and based on the day.</prim_outcome>
      <prim_outcome>Incidence of necrotizing enterocolitis. Timepoint: The disease occurs most of the time with the onset of nutrition and during the hospital stay. Method of measurement: According to the "Bell's criteria".</prim_outcome>
      <prim_outcome>Time required for the respirator. Timepoint: Duration of treatment with respirator. Method of measurement: Evidence available in the clinical file and based on the day.</prim_outcome>
      <prim_outcome>Prevalence of retinopathy of  prematurity. Timepoint: Ophthalmologic examination for all newborns will be done in about 1 month of age. Method of measurement: It will be calcified according the extent of the vessels of the bottom of the eye.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-29</approval_date>
        <contact_name>Ethic committee of shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Mofid Children Hospital, Shariati St.,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
