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

S

SISAY GERE

Status

Completed

Conditions

Oxygen Saturation
Body Temperature
Respiratory Rate
Sleep Pattern
Heart Rate

Treatments

Other: Chest-to-back

Study type

Interventional

Funder types

Other

Identifiers

NCT04346498
A/CHS/RC/15/16

Details and patient eligibility

About

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

Full 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).

Enrollment

50 patients

Sex

All

Ages

1 to 28 days old

Volunteers

No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups, including a placebo group

CB-SSC
Experimental group
Description:
The participant received CB-SSC for 2 hours per day for three consecutive days
Treatment:
Other: Chest-to-back
CC-SSC
Placebo Comparator group
Description:
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
Treatment:
Other: Chest-to-back

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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