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| Name | Class |
|---|---|
| Arsi University | OTHER |
| Addis Continental Institute of Public Health | OTHER |
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The purpose of this study was to assess the effectiveness of Kangarooing small babies on the back of a mother
After the study was explained (risks and benefits) and written informed consent was received from participants, an individually controlled randomized crossover clinical trial was conducted to examine the effectiveness of Chest-to-Back (CB) skin-to-skin contact (SSC) compared with the standard. The trial was done in accordance with the protocol, good clinical practice, and the national regulatory and ethics guideline of Ethiopia (which is in line with the Helsinki declaration).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CB-SSC | Experimental | The participant received CB-SSC for 2 hours per day for three consecutive days |
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| CC-SSC | Placebo Comparator | Following a 30 minute washout time, the same participant would continue to receive chest-to-chest (CC) SSC for 2 hours. This was also conducted for three consecutive days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest-to-back | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in skin temperature from baseline | Skin temperature values were recorded every 10 minutes. Including the baseline, the 2 hours intervention would provide 13 measurements. A participant who successfully completed the intervention would have78 measurements; 39 for the treatment arm and 39 for the control arm. | : From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in peripheral arterial oxygen saturation on SCRIP Score | Stability of the cardio-respiratory system in premature infants (SCRIP) score is a reliable instrument for determining the stability of oxygen saturation (i.e., peripheral arterial oxygen saturation) in premature infants. Possible scores range from 2 (perfect stability= > 90 %) to 0 (sever instability = any falls below 80%) | From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Yemane Berhane | Director | Study Director |
| Prof. Alemayehu Worku | Deputy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adds Continental Institute of Public Health | Addis Ababa | Ethiopia |
Upon a reasonable request, the investigators can offer access to the datasets used and/or analyzed. This can be available from the PI (principal investigator)
Possibly after six months the data will be available.
Upon reasonable request!
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Mothers were masked only for the presence or absence of a sequence in the trial. Hospital staffs, students, and investigators of the study were all blinded to allocation of the intervention. Until the study was finalized, access to the database was restricted to the data manager only
| Change from baseline in heart rate on SCRIP Score | Possible scores range from 2 (perfect stability= regular) to 0 (sever instability = < 80/min or>200). | From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days |
| Change from baseline in respiratory rate on SCRIP Score | Possible scores range from 2 (perfect stability= regular) to 0 (sever instability = Apnea> 10, Tachypnea> 80/min, fussing/agitation | From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days |
| Length of sleep in minute | length of sleep was defined by the duration between the time of closed eyes, no crying and no movement to the time that at least one of these 3 indicators is absent | From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days. |