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

NCT04346498 | Completed DMC

• 1 other identifier: A/CHS/RC/15/16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (4)

• 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

• 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

• 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

Study Arms (2)

CB-SSC

EXPERIMENTAL

The participant received CB-SSC for 2 hours per day for three consecutive days

Other: Chest-to-back

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

Other: Chest-to-back

Interventions

Chest-to-back OTHER

Also known as: The standard/or Chest-to-chest

CB-SSC; CC-SSC

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates with LBW (\<2500 grams)
• Born prematurely (\< 37 complete weeks of gestation)

You may not qualify if:

• less than 35 weeks of gestation on the day of enrollment to trial
• Malformations or birth disabilities
• Dependent on oxygen or IV fluid

Sponsors & Collaborators

• SISAY GERE: lead
• Arsi University: collaborator
• Adds Continental Institute of Public Health: collaborator

Study Sites (1)

Adds Continental Institute of Public Health

Addis Ababa, Ethiopia

Location

Study Officials

• Prof. Yemane Berhane

  Director

  STUDY DIRECTOR

• Prof. Alemayehu Worku

  Deputy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc, PhD candidate, and lecturer at Arsi University College of Health Sciences, Ethiopia

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 15, 2020
• Study Start: January 3, 2017
• Primary Completion: June 18, 2019
• Study Completion: October 14, 2019
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Possibly after six months the data will be available.
• Access Criteria: Upon reasonable request!

Locations

ET (1)