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

Not Applicable

Completed

• Conditions: Respiratory Rate; Body Temperature; Oxygen Saturation; Heart Rate; Sleep Pattern
• Interventions: Other: Chest-to-back

• Registration Number: NCT04346498
• Lead Sponsor: SISAY GERE

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).

Study Timeline

• Study Start: 2017-01-03
• Primary Completion: 2019-06-18
• Study Completion: 2019-10-14
• Status Verified: 2020-04
• Study First Submitted: 2020-04-11
• Study First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-14
• Study First Posted: 2020-04-15
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CC-SSC	Chest-to-back	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
CB-SSC	Chest-to-back	The participant received CB-SSC for 2 hours per day for three consecutive days

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Adds Continental Institute of Public Health; 🇪🇹 Addis Ababa, Ethiopia