<?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>IRCT2015070123003N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-09</date_registration>
      <primary_sponsor>-</primary_sponsor>
      <public_title>Developmental care</public_title>
      <acronym>-</acronym>
      <scientific_title>Impact of developmental care on length of stay in infant undergoing mechanical ventilation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19740</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>2</phase>
      <hc_freetext>respiratory distress syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Researcher in NICƯ Mahdieh Hospital will present and in relation with the developmental intervention, required explanations will give to nurses. In researcher initially will introduce herself and objectives to the parents of neonates who had inclusion criteria for the study and will sign an informed consent by parents. Then, the first part of a demographic questionnaire will complete by the researcher and the date of onset of mechanical ventilation will record. Developmental care interventions will receive by all neonates who had eligible for inclusion through a trained nurse. Care in the intervention group will maintain until the end of the need for mechanical ventilation. Intervention 2: Inpatient neonates of NICUS̛ Mofid Children's Hospital, Imam Hossein and Shohada Tajrish, Tehran as the control group will receive daily care. Researcher in theses hospitals will attend and demographic information questionnaire will fulfill, also the onset and end time that need for mechanical ventilation for 30 cases will record.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sima Sabaghi Faradonbeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No19, Next to Hemat bridge, Street SHahid Abbaspoor, , Vali asr(AJ), Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14155-3693</zip>
        <telephone>+98 21 8820 9020</telephone>
        <email>ib@sbmu.ac.ir</email>
        <affiliation>International Branch of Beheshti University of Medical Science and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Manigheh Nourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Niayesh Complex, Niayesh Cross Road, Vali Asr Ave, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 218865536671</telephone>
        <email>sbnmf@sbmu.ac.i</email>
        <affiliation>SHahid Beheshti University of Medical Science, School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: gestational age less than 33 weeks with birth; weight equal or less than 2500 g; neonates suffered from  respiratory distress syndrome; mechanical ventilation &gt; 24 hours of first 48 hours of life. &#13;
Exclusion criteria: treatment with surfactant; congenital anomalies; asphyxia; respiratory disorders; cyanotic heart disease; mouth and facial abnormalities; maternal use of opium drugs during pregnancy; neonatal death; intraventricular hemorrhage ( grade 3 or 4) alongside hydrocephalus; sepsis; necrotizing enterocolitis ; growth disorders; bronchopulmonary dysplasia; patent ductus arteriosus requiring treatment; pneumonia caused by mechanical ventilation.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>28 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>p 22.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hyaline membrane disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Researcher in NICƯ Mahdieh Hospital will present and in relation with the developmental intervention, required explanations will give to nurses. In researcher initially will introduce herself and objectives to the parents of neonates who had inclusion criteria for the study and will sign an informed consent by parents. Then, the first part of a demographic questionnaire will complete by the researcher and the date of onset of mechanical ventilation will record. Developmental care interventions will receive by all neonates who had eligible for inclusion through a trained nurse. Care in the intervention group will maintain until the end of the need for mechanical ventilation.</i_keyword>
      <i_keyword>Inpatient neonates of NICUS̛ Mofid Children's Hospital, Imam Hossein and Shohada Tajrish, Tehran as the control group will receive daily care. Researcher in theses hospitals will attend and demographic information questionnaire will fulfill, also the onset and end time that need for mechanical ventilation for 30 cases will record.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Developmental care. Timepoint: after intervention. Method of measurement: Data collection included three part demographic questioner. First part, demographic information including weight, sex, age, type of birth, apgar score at the first minute, apgar score at 5 minute that completed under supervision of researchers at the hospitals for intervention groups. Secondary part including developmental care interventions consist of: change the position every 2-3 hours, hand near face, nesting, Right side or prone position to improve gastric emptying and reduce the effects of gastroesophageal reflux, non-nutritive sucking before invasive intervention and gavage, Using gentle and quiet handling techniques, trunk flexion, shoulder and hip flexion and adduction, prevent suddenly change position and Keep hands of care keeper over the baby's head before beginning any care for providing the infant's sense of care and third part including the onset and end time that need for mechanical ventilation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of mechanical ventilation. Timepoint: Since the beginning of mechanical ventilation until maintained until the end of the need for mechanical ventilation. Method of measurement: Number of days.</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>-</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-04</approval_date>
        <contact_name>The ethics committee of  International Branch of Behesti University of Medical Sciences and Health S</contact_name>
        <contact_address>No.19, Next to Hemat bridge, Street SHahid Abbaspoor,  Vali asr(AJ), Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
