Can Kangarooing Small Babies on the Back of a Mother Keep Them Warm and Stable

Heart Rate Clinical Trial

Official title:

The Effect of Chest-to-Back Skin-to-Skin Contact on Regulation of Physiological Parameters for Low Birth Weight and/or Premature Infants: a Crossover Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346498
• Other study ID #: A/CHS/RC/15/16
• Status: Completed
• Phase: N/A
• Start date: January 3, 2017
• Est. completion date: October 14, 2019

Study information

• Verified date: April 2020
• Source: Addis Continental Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to assess the effectiveness of Kangarooing small babies on the back of a mother

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 14, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Body Temperature
• Heart Rate
• Oxygen Saturation
• Respiratory Rate
• Sleep Pattern

Intervention

Other:
• Chest-to-back

Locations

Country	Name	City	State
Ethiopia	Adds Continental Institute of Public Health	Addis Ababa

Sponsors (3)

Lead Sponsor	Collaborator
SISAY GERE	Adds Continental Institute of Public Health, Arsi University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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.
Primary	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