Body Temperature, Heart Rate, Oxygen Saturation, Respiratory Rate, Sleep Pattern
Conditions
Brief summary
The purpose of this study was to assess the effectiveness of Kangarooing small babies on the back of a mother
Detailed description
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).
Interventions
OTHERChest-to-back
Sponsors
Arsi University
Adds Continental Institute of Public Health
SISAY GERE
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* Neonates with LBW (\<2500 grams) * Born prematurely (\< 37 complete weeks of gestation)
Exclusion criteria
* less than 35 weeks of gestation on the day of enrollment to trial * Malformations or birth disabilities * Dependent on oxygen or IV fluid * Any disorder that was deemed necessary for exclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin temperature from baseline | : From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in peripheral arterial oxygen saturation on SCRIP Score | From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days | 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%) |
| Change from baseline in heart rate on SCRIP Score | From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days | Possible scores range from 2 (perfect stability= regular) to 0 (sever instability = \< 80/min or\>200). |
| Change from baseline in respiratory rate on SCRIP Score | From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days | Possible scores range from 2 (perfect stability= regular) to 0 (sever instability = Apnea\> 10, Tachypnea\> 80/min, fussing/agitation |
| Length of sleep in minute | From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days. | 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 |
Countries
Ethiopia
Outcome results
None listed