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Completed

NCT Number: NCT04346498

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

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

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Key information

Conditions

Body Temperature Heart Rate Oxygen Saturation Respiratory Rate Sleep Pattern

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adds Continental Institute of Public Health

Addis Ababa, Ethiopia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chest-to-back

Other

Other names: The standard/or Chest-to-chest

Primary outcomes

  1. 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.

Other outcomes

  1. Change from baseline in peripheral arterial oxygen saturation on SCRIP Score

    Time frame: From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days

    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%)

  2. Change from baseline in heart rate on SCRIP Score

    Time frame: From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days

    Possible scores range from 2 (perfect stability= regular) to 0 (sever instability = < 80/min or>200).

  3. Change from baseline in respiratory rate on SCRIP Score

    Time frame: From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days

    Possible scores range from 2 (perfect stability= regular) to 0 (sever instability = Apnea> 10, Tachypnea> 80/min, fussing/agitation

  4. Length of sleep in minute

    Time frame: From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days.

    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

Sponsors and collaborators

Lead sponsor

SISAY GERE

Other

Collaborators

  • Addis Continental Institute of Public Health
  • Arsi University

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 15, 2020
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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