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

NCT ID: NCT04346498

Last Updated: 2020-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-03

Study Completion Date

2019-10-14

Brief Summary

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

Detailed Description

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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).

Conditions

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Body Temperature Oxygen Saturation Heart Rate Respiratory Rate Sleep Pattern

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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

Study Groups

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CB-SSC

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

Group Type EXPERIMENTAL

Chest-to-back

Intervention Type OTHER

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

Group Type PLACEBO_COMPARATOR

Chest-to-back

Intervention Type OTHER

Interventions

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Chest-to-back

Intervention Type OTHER

Other Intervention Names

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The standard/or Chest-to-chest

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arsi University

OTHER

Sponsor Role collaborator

Adds Continental Institute of Public Health

UNKNOWN

Sponsor Role collaborator

SISAY GERE

OTHER

Sponsor Role lead

Responsible Party

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SISAY GERE

MSc, PhD candidate, and lecturer at Arsi University College of Health Sciences, Ethiopia

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Prof. Yemane Berhane

Role: STUDY_DIRECTOR

Director

Prof. Alemayehu Worku

Role: STUDY_CHAIR

Deputy

Locations

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Adds Continental Institute of Public Health

Addis Ababa, , Ethiopia

Site Status

Countries

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Ethiopia

Other Identifiers

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A/CHS/RC/15/16

Identifier Type: -

Identifier Source: org_study_id

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