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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Rate; Respiratory Rate; Oxygen Saturation; Body Temperature; Sleep Pattern
• Intervention / Treatment: Other: Chest-to-back

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • Adds Continental Institute of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CB-SSC; The participant received CB-SSC for 2 hours per day for three consecutive days	Other: Chest-to-back; Other Names: The standard/or Chest-to-chest
Placebo Comparator: CC-SSC; 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; Other Names: The standard/or Chest-to-chest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
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.

Collaborators and Investigators

• Sponsor: SISAY GERE
• Collaborators: Arsi University; Adds Continental Institute of Public Health
• Investigators: Study Director: Prof. Yemane Berhane, Director; Study Chair: Prof. Alemayehu Worku, Deputy

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Actual): June 18, 2019
• Study Completion (Actual): October 14, 2019

Study Registration Dates

• First Submitted: April 11, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: A/CHS/RC/15/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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)
• IPD Sharing Time Frame: Possibly after six months the data will be available.
• IPD Sharing Access Criteria: Upon reasonable request!
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No