<?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>IRCT20220130053890N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-26</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>milrinone in persistent neonatal pulmonary hypertension</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the efficacy of inhaled versus infused milrinone in management of persistent pulmonary hypertension(PPHN) in infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61634</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization with blocks, using binary blocks, Randomization of blocks using random number table.
The intervention and control groups are called A and B, respectively, we prepare two series of blocks No. 1 (AB) and No. 2 (BA). Select a point in the table of random numbers at random and start moving in one direction. In each cell of the table, if the digit is an odd number, select block 1, and if it is even, selects block two, and place it in a row until 16 blocks selected (based on sample size). Then, each eligible patient who entered the study will be placed in the intervention or control group according to the order obtained, Blinding description: The patient's echocardiography is performed by a different pediatrician who is unaware of the type of treatment intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>neonatal.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: treated with intravenous infusion of dopamine at a dose of 5 macro per kg body weight per minute for 3 to 5 days according to the doctor and then receive inhaled milrinone at a rate of 50 micrograms per kilogram body weight, during For 10 minutes with a frequency of twice a day. the intervention continues until the symptoms improve or the symptoms of respiratory distress or the need for oxygen increase. Intervention 2: Intervention group: Treated with intravenous infusion of dopamine at a dose of 5 macro per kg of infant weight per minute for 3 to 5 days according to the doctor's opinion and then, continuous injection of 0.3 to 0.5 micrograms per kg of body weight per minute Milrinone as a continuous intravenous infusion. the intervention continues until the symptoms improve or the symptoms of respiratory distress or the need for oxygen increase.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>peyman shahhosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 174, Mozaffarikhah St., North Kargar St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1413654591</zip>
        <telephone>+98 21 8801 6197</telephone>
        <email>peishah@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Peyman shahhosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 174, Mozaffarikhah St., North Kargar St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1413654591</zip>
        <telephone>+98 21 8801 6197</telephone>
        <email>peishah@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infants 1 to 28 days with a diagnosis of persistent pulmonary hypertension (diagnosed on Basis of echocardiographic findings) and hospitalization in the NICU.
Indicated for receiving treatment based on the diagnosis of the treating physician.
Existence of informed consent of parents to enter the study.</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>28 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Neonates with congenital heart disorders, diaphragmatic hernias, pulmonary abnormalities.
infants are candidates for major surgery to eliminate abnormality.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: treated with intravenous infusion of dopamine at a dose of 5 macro per kg body weight per minute for 3 to 5 days according to the doctor and then receive inhaled milrinone at a rate of 50 micrograms per kilogram body weight, during For 10 minutes with a frequency of twice a day. the intervention continues until the symptoms improve or the symptoms of respiratory distress or the need for oxygen increase.</i_keyword>
      <i_keyword>Intervention group: Treated with intravenous infusion of dopamine at a dose of 5 macro per kg of infant weight per minute for 3 to 5 days according to the doctor's opinion and then, continuous injection of 0.3 to 0.5 micrograms per kg of body weight per minute Milrinone as a continuous intravenous infusion. the intervention continues until the symptoms improve or the symptoms of respiratory distress or the need for oxygen increase.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pulmonary artery pressure:  pulmonary artery pressure greater than 40 mm Hg is considered PPHN. Timepoint: it is measured at first, during the first 24 hours of hospitalization, 24 hours after the start of treatment, and when the infant shows signs of respiratory distress or increased oxygen demand. Method of measurement: Pulmonary artery pressure is determined by M-mode, two-dimensional, and color-Doppler echocardiography using the Bernoulli formula.                                                                        Bernoulli equation: pulmonary artery systolic pressure (PASP) = tricuspid regurgitation gradient + right atrial pressure (RAP), PASP = (Vmax2 × 4) + RAP.</prim_outcome>
      <prim_outcome>Systemic artery pressure: Systolic and diastolic blood pressure. Timepoint: daily. Method of measurement: Using the NICU monitoring device.</prim_outcome>
      <prim_outcome>Signs of respiratory distress: Respiratory distress in the newborn is recognized as one or more signs of increased work of breathing, such as tachypnea, nasal flaring, chest retractions, or grunting. Timepoint: The baby is constantly monitored. Method of measurement: Through clinical examination of the patient.</prim_outcome>
      <prim_outcome>Oxygenation index(OI) : is used to assess the severity of hypoxic respiratory failure (HRF) and persistent pulmonary hypertension of the newborn (PPHN). Timepoint: Daily and at the time of respiratory distress. Method of measurement: It is calculated by the following formula:                                                                        (OI=mean airway pressure MAP × FiO2 × 100÷PaO2).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Die or survive. Timepoint: During treatment. Method of measurement: See the patient.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-21</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>No. 174, Mozaffarikhah St., North Kargar St., Tehran Tehtan Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
