Records View

Effects of infant sensory-motoe and proprioceptive stimulation with oral stimulation on intake fluid and Stress response in Prematrue babies

Status Approved

  • First Submitted Date

    2019/11/04

  • Registered Date

    2019/11/28

  • Last Updated Date

    2019/11/19

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004479
    Unique Protocol ID 2-1040781-AB-N-01-2018088HR
    Public/Brief Title Effects of infant sensory-motoe and proprioceptive stimulation with oral stimulation on intake fluid and Stress response in Prematrue babies
    Scientific Title Effects of infant sensory-motoe and proprioceptive stimulation with oral stimulation on intake fluid and Stress response in Prematrue babies
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2-1040781-AB-N-01-2018088HR
    Approval Date 2019-02-26
    Institutional Review Board Name sahm-yook university Institutional Review Board, IRB
    Institutional Review Board Address 815, Hwarang-ro, Nowon-gu, Seoul, 01795 Rep. of KOREA
    Institutional Review Board Telephone 02-3399-3636
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name seonghyeok song
    Title student
    Telephone +82-2-3399-3636
    Affiliation Sahmyook University
    Address 815, Hwarang-ro, Nowon-gu, Seoul, 01795 Rep. of KOREA
    Contact Person for Public Queries
    Name seonghyeok song
    Title student
    Telephone +82-2-3399-3636
    Affiliation Sahmyook University
    Address 815, Hwarang-ro, Nowon-gu, Seoul, 01795 Rep. of KOREA
    Contact Person for Updating Information
    Name seonghyeok song
    Title student
    Telephone +82-2-3399-3636
    Affiliation Sahmyook University
    Address 815, Hwarang-ro, Nowon-gu, Seoul, 01795 Rep. of KOREA
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2019-02-26 Actual
    Target Number of Participant 65
    Primary Completion Date 2019-05-10 , Actual
    Study Completion Date 2019-05-17 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Hallym University Medical Center-Hangang
    Recruitment Status Completed
    Date of First Enrollment 2019-02-26 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Sahmyook University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Sahmyook University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    1. Research Purpose :  physical therapy of oaral and normal developmental sensory-motor stimualtion approaches to Preamarue infants and we study postitive and emotinal stable good effect  with fluid intakeing rate, weihgt in this section. we will investigate the effects of tretment and stress factors in mental index to prepre edivence to article
    
    2. Research design : randomized expeirmental research
    
    3. research period : The currentl study has ended
    
    4. research subject : 65
    
    5.research method 
    
    The purpose of this study was to evaluate the effects of oral and sensory-motor stilmulation with physical therapy on premature infants after fluid intaking with  oral stimulation and physical activity in the neonatal intensive care unit (APGAR, Apgar score 1min, Apgar score 5min).
    
    The subjects were screened for general nursing intervention, and the experimental group underwent 15 minutes of lower extremity muscle massage during the proprioceptive sensory-motir stimulation  physical activity. 
     The subjects of this experiment were retrospective chart analysis that was not previously mediated by oral interventions and physical activities. During the intervention period, all patients were treated except for urgent surgery of neonatal race and umbilical membrane surgery. After confirming the chart of the experimental group, cortisol, the feeding rate and the stress response index, was collected and analyzed through the post-feeding chart.
    
    6. Research subject's risk 
    vomiting, diarrhea and other organ disorders, and redness, pain and swelling at the injection site of patients
    No adverse events occurred (at least 1 in 100 patients and less than 1 in 100 patients). and take care sanitary with subject
    
    7. Injury Measures and Compensation
    In the case of physical and mental disorders related to this study, the appropriate clinical trial manager (person in charge) provides an opportunity for appropriate treatment.
    8. Benefits of Research subjects
    we take to parents physical status and lactational state stress evaluation paper  during the intervention period
    Free of charge.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Supportive Care
    Phase Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Others (oral stimulation, massage, normal developmental physical therapy)
    Intervention Description
    1.cortisol serum was measured using venous blood from ADVIA Centaur XP (Immunoassay system: Siemens medical solution diagnostics, Tarrytown, NY, USA) before and after intervention for one week and analyzed by CLIA method. This medical record was measurement result after checking on the record sheet.
    2.The oral stimulation program applied the oral stimulation program developed by Fucile to the cheeks, lips, gums, the inside of the cheeks, the side of the tongue, the front of the tongue and the palate, the palate, and the duration, location, performance, intensity, and frequency.
    
    3.. Before begin experiment physiotherapy for premature babies, babies were called with soft voices such as 'my baby' and 'Let's sleep' to induce psychological stability and preparation. Before the baby's physiotherapy, the physiotherapist and nurse wash their hands thoroughly, lay the baby on the sheep's stomach in a quiet place, apply baby oil to both palms and rub the palms of the palms to reduce skin friction approached. The sensory-motor  stimulation gently stroked the head, shoulders, back, and legs in the abdominal posture from the head to the tail. Each time, the left and right 10 times was carried out for 5 minutes. When the baby showed obvious signs of rejection, such as crying, grimacing, vomiting or shedding, or blocking by hand, the patient wrapped around the baby to maintain the bend of the arms and legs. In the case of a clear rejection or avoidance signal, the massage was performed within 20 seconds and stopped again. The average time for providing one physiotherapy was about 15 minutes.
    Number of Arms 1
    Arm 1

    Arm Label

    oral stimulation and physical therapy

    Target Number of Participant

    65

    Arm Type

    Others

    Arm Description

    1.The oral stimulation program applied the oral stimulation program developed by Fucile to the cheeks, lips, gums, the inside of the cheeks, the side of the tongue, the front of the tongue and the palate, the palate, and the duration, location, performance, intensity, and frequency.
    
    3.. Before begin experiment physiotherapy for premature babies, babies were called with soft voices such as 'my baby' and 'Let's sleep' to induce psychological stability and preparation. Before the baby's physiotherapy, the physiotherapist and nurse wash their hands thoroughly, lay the baby on the sheep's stomach in a quiet place, apply baby oil to both palms and rub the palms of the palms to reduce skin friction approached. The sensory-motor  stimulation gently stroked the head, shoulders, back, and legs in the abdominal posture from the head to the tail. Each time, the left and right 10 times was carried out for 5 minutes. When the baby showed obvious signs of rejection, such as crying, grimacing, vomiting or shedding, or blocking by hand, the patient wrapped around the baby to maintain the bend of the arms and legs. In the case of a clear rejection or avoidance signal, the massage was performed within 20 seconds and stopped again. The average time for providing one physiotherapy was about 15 minutes.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    Not Applicable-Etc 

    The subjects study were premature babies who were admitted to the Intensive Care Unit of the Seoul National University Hospital from April 2018 and are premature infants with disease code [P0730 ~ P0731]
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    1Month~3Month

    Description

    include creteria
    The subjects of this study were as follows. 1) Premature infants weighing less than 2,000 g before experimental treatment; 2) Premature infants without neonatal congenital deformity , respiratory distress, sepsis, lactation disorder and congenital malformations during experimental treatment
    Exclusion Criteria
    exclude criteria
    1) The stage of intracranial hemorrahrge is IV or more
      2) Premature infants weighing more than 2000g
      3) Premature infants with a gestational age of 30 weeks
      4) Those who were found to be difficult to conduct the experiment due to serious medical and surgical diseases by the investigator.
      5) those with malformations of the intestines and heart
      6) Other subjects (researchers or students participating in the study, researchers or students of the researcher involved in the study, the family of the subject)
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    fluid intake of premature infants
    Timepoint
    After three weeks of eight weeks intervention
    Primary Outcome(s) 2
    Outcome
    strees cortisl index of premature infants
    Timepoint
    After three weeks of eight weeks intervention
    Secondary Outcome(s) 1
    Outcome
    phsical sign of premature infants
    Timepoint
    before intervention and after 3weeks of 8weeks
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동