Body TemperatureNCT04346498
Can Kangarooing Small Babies on the Back of a Mother Keep Them Warm and Stable
A study testing Chest-to-back in people with Body Temperature and Oxygen Saturation, run by SISAY GERE at 1 site in Ethiopia.
Trial summary
The purpose of this study was to assess the effectiveness of Kangarooing small babies on the back of a mother Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Body Temperature, Oxygen Saturation, Heart Rate
- What is being tested?
- Chest-to-back
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEthiopia
- Study dates
- 3 Jan 2017to 14 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with LBW (<2500 grams)
- Born prematurely (< 37 complete weeks of gestation)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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).
- Conditions
- Body Temperature, Oxygen Saturation, Heart Rate, Respiratory Rate, Sleep Pattern
- Being tested
- Chest-to-back
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest-to-backOther
Also called The standard/or Chest-to-chest
| Study group | Role | What they receive |
|---|---|---|
| CB-SSC | Experimental | The participant received CB-SSC for 2 hours per day for three consecutive days Receives: 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 Receives: Other: Chest-to-back |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: : From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start3 Jan 2017
- Primary completion18 Jun 2019
- Study completion14 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body TemperatureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- SISAY GERE
- Sponsor type
- University, hospital or other
- Collaborators
- Arsi University, Addis Continental Institute of Public Health
- Responsible party
- Sponsor-investigator, SISAY GERE, Addis Continental Institute of Public Health
- Investigators
- Prof. Yemane Berhane, Study director, DirectorProf. Alemayehu Worku, Study chair, Deputy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346498
- Sponsor's protocol ID
- A/CHS/RC/15/16
- Status last verified
- Apr 2020
- First submitted
- 11 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04346498
- Acronym / sponsor ID
- A/CHS/RC/15/16
- Conditions
- Body Temperature, Oxygen Saturation, Heart Rate, Respiratory Rate, Sleep Pattern
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SISAY GEREUniversity, hospital or other
- Collaborators
- Arsi University, Addis Continental Institute of Public Health
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess the effectiveness of Kangarooing small babies on the back of a mother
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CB-SSC | Experimental | Other: Chest-to-backThe participant received CB-SSC for 2 hours per day for three consecutive days |
| CC-SSC | Placebo comparator | Other: Chest-to-backFollowing 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 |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Neonates with LBW (<2500 grams)
- Born prematurely (< 37 complete weeks of gestation)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest-to-backAlso: The standard/or Chest-to-chest | Other | CB-SSC, CC-SSC |
Primary outcome
Change in skin temperature from baseline
Time frame: : From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Yemane Berhane study director
Director
Prof. Alemayehu Worku study chair
Deputy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest-to-back in people with Body Temperature and Oxygen Saturation, run by SISAY GERE at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin temperature from baseline (time frame: : From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.