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
CRIS Registration Number |
KCT0004479 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Sahmyook University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Sahmyook University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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] |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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