<?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>IRCT201405208315N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-25</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of physical activity on Physiological and Behavioral Responses, Motor performance and Neuro-mascular Development</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of Physical Activity Programs on Physiological and Behavioral Responses, Motor Performance and Neuromuscular Development in preterm Infants: Single blind Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8765</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>1-Preterm Infant 2- low birth weight.</hc_freetext>
      <i_freetext>Intervention 1: 1-The physical activity program wil be based on the Moyer-Mileur protocol. Then repetitions of each movement were performed on the Wrists, Elbows, Shoulders, Ankles, Knees and Hips joints. The sequence was performed slowly and in the cephalocaudal direction, with an average of six movements per min, and in the following sequence: right arm, left arm, right leg, left leg and, finally, simultaneous movements on both legs.¬ Intervention will be done for a total of 15 min.&#13;
2- Hydrotherapy activity will be done semi-circular movements in the pelvic area while the head and neck will constant and then semi-circular motions will performed in the head and neck while the pelvis will be constant. Intervention will be done for a total of 10 min. &#13;
3- Containment include putting the infant in fetal position (feet gathered on the abdomen and head bent the chest). Baby will be hold Daily once for 15 minutes. Intervention 2: Holding group’s :The researcher will be kept baby in fetal position to support the head¬, neck and extremities (the bent in the midline) for 15 min, once daily. Intervention 3: Hydrotherapy groups: semi rotational movements of the head and neck will be doing while pelvic area is constant and  then semi rotational movements of the pelvic will be doing while the head and upper parts are constant , it will run during 10 minutes.</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>mahnaz sanaeifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 44 3623 0217</telephone>
        <email>maha.sanaeifar@yahoo.com</email>
        <affiliation>Tabriz nursing and midwifere faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Valizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz Faculty of Nursing and Midwifery,South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 1479 6770</telephone>
        <email>valizadehl@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Gestational age 26-30 weeks; Post conception age 32 weeks; Birth weight at least 800 gram; Weight the studying time 1000-2000 gr; Appropriate Gestational age; APGAR scores more than 7; Mother has not drug abuse; Infant isn't IUGR; Infant has a Positive history of mechanical ventilation(Mechanical ventilation, CPAP, Oxyhood) at least for 3 days and use of sedative drug; Infant has not any medicine and metabolic disorders; Absence of neurological anomalies, congenital and chromosomal abnormalities. Exclusion Criteria: Delayed diagnosis of neural anomalies, Congenital and chromosomal abnormalities at 32 to 34 weeks; Severe infection and diseases require to surgery and photo-therapy at 32 to 34 weeks; Physiological instability during the program, as HR more than 180 or HR less than  100 and SaO2 drops to less than 88% twice a day during the intervention (Particularly during the Hydrotherapy); Diagnosis the cardiovascular and musculoskeletal diseases, hip dislocation and Erb Duchenne paralysis during the study; Transfer to another facility during the intervention.</inclusion_criteria>
      <agemin>7 days</agemin>
      <agemax>2 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>p07 ,p07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders related to short gestation and low birth weight, not elsewhere classified. 2-Other low birth weight</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1-The physical activity program wil be based on the Moyer-Mileur protocol. Then repetitions of each movement were performed on the Wrists, Elbows, Shoulders, Ankles, Knees and Hips joints. The sequence was performed slowly and in the cephalocaudal direction, with an average of six movements per min, and in the following sequence: right arm, left arm, right leg, left leg and, finally, simultaneous movements on both legs.¬ Intervention will be done for a total of 15 min.&#13;
2- Hydrotherapy activity will be done semi-circular movements in the pelvic area while the head and neck will constant and then semi-circular motions will performed in the head and neck while the pelvis will be constant. Intervention will be done for a total of 10 min. &#13;
3- Containment include putting the infant in fetal position (feet gathered on the abdomen and head bent the chest). Baby will be hold Daily once for 15 minutes.</i_keyword>
      <i_keyword>Holding group’s :The researcher will be kept baby in fetal position to support the head¬, neck and extremities (the bent in the midline) for 15 min, once daily.</i_keyword>
      <i_keyword>Hydrotherapy groups: semi rotational movements of the head and neck will be doing while pelvic area is constant and  then semi rotational movements of the pelvic will be doing while the head and upper parts are constant , it will run during 10 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physiologic indexs(Heart rate, Respiration Rate, Saturation Oxygen).2- Behavioral responses. Timepoint: 1- The two first and last sessions of intervention (before, during and after the intervention). Method of measurement: 1- Pulse oximetre set.  2- APIB: Assessment of Preterm Infant’s Behavior.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>1-motor performance 2- neuromuscular developmental of Joint of Wrists, Elbows, Shoulders, Ankles, Knees, Thighs. Timepoint: 1-Before the first session and after the last session of the intervention. 2-Before the first session and after the last session of the intervention. Method of measurement: 1- Test of Infant Motor Performance (TIMP) 2-Selected items from Neuromuscular maturity NEW Ballard and Dubowitz scales.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-14</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>South Shariati Ave. Nursing and Midwifery Faculty Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
