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

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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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