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CompletedNCT04908332KBMUpdated Mar 4, 2022

Effect of Kangaroo Baby Massage on Mother-infant Interaction at Home

An interventional study of Kangaroo Baby Massage in Premature, Low Birth Weight and Mother-Infant Interaction, sponsored by Universidad Nacional de Colombia. Completed at 1 site in Colombia. Open to participants aged 2 Days to 3 Months. Per ClinicalTrials.gov, last updated 2022-03-04.

Sponsored by Universidad Nacional de Colombia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
2 Days to 3 Months
Sex
All
01

Study summary

The objective of this randomized clinical trial will determine the effectiveness of nursing intervention (Kangaroo Baby Massage) on the interaction between mothers and premature, low birth weight infants at home The dyad mother- infant of the control group will receive Kangaroo position KP and the dyad mother- infant mothers of the intervention group will receive the Kangaroo Baby Massage KBM

Read the detailed description

Participants and methods: 68 dyads mother-infant will randomize, 34 in intervention KBM group and 34 in control group KP, previous they meet inclusion criteria and accept their participation through informed consent. weight gain and Kangaroo position days at home will be the primaries outcomes. The Alert states, Types of BC feeding, Perceived maternal parental self-efficacy and Postnatal depression. Will be secondary outcomes.

Barnard's mother-child interaction theory supports the study

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Conditions studied

  • Premature
  • Low Birth Weight
  • Mother-Infant Interaction
  • Gain, Weight
  • Depression, Post-Partum
  • Breastfeeding
  • Feeding, Breast

Keywords

  • Massage
  • Kangaroo mother care
  • low birth weight infant
  • premature infant
  • Mother- infant interaction
  • domiciliary
  • Nursing
  • home health nursing
  • telenursing
03

In context

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's enrollment of 68 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Universidad Nacional de Colombia is the lead sponsor of 38 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Days to 3 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Prematures and low birth weight infants in Kangaroo position with a chronological age less than 3 months
  • The mothers take care the infant at home
  • Baby with a weight equal to or greater than 1800 grams at the time of entry to the study.
  • Baby whose birth was institutional or extra-institutional.
  • Mothers with training in the Kangaroo Mother Program
  • Children controlled in the Ambulatory Kangaroo Mother Program

Exclusion criteria

Exclusion Criteria

  • Children diagnosed with intraventricular hemorrhages grade III and IV or congenital malformations
  • Children who have more than one ambulatory kangaroo control
  • Children who have been at home for more than 3 days without starting the ambulatory kangaroo control
  • Babies with infections and other pathologies that require hospitalization during the study
  • Presence of infectious diseases and other pathologies in the mother that require hospitalization
  • Mother confirmed with positive test for covid 19 at the moment of the randomization
  • Mothers with cognitive problems or mental disorders.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Kangaroo baby Massage

    The mother will apply the massage. The baby kangaroo will be exposed to the KBM for 10 minutes once a day during the time that the infant need to stay in kangaroo position at home. If the baby wakes up and wants to eat the KBM will be interrupted immediately and the baby will be fed, The temperature will be measured before and after the intervention. The massage will begin 60 minutes after the feed.

    Behavioral: Kangaroo Baby Massage

  • Active comparator
    Kangaroo position

    The infant must be in Kangaroo position with the mother semi sitting on bed with elevation of at least 30 degrees during 10 minutes every day until the infant doesn´t need to stay in kangaroo position at home.The temperature will be measured 60 minutes after the feed and 10 minutes after KP. If the baby wakes up and wants to eat the KP will be interrupted immediately and the baby will be fed, then the KP will be completed of time ( 10 minutes) to measure the temperature.

    Behavioral: Kangaroo Baby Massage

Interventions

  • BehavioralKangaroo Baby Massage

    The Kangaroo Baby Massage is an intervention that arose from nursing practice in 1996. It is a therapy that does not require an incubator, fuses massage, kangaroo position and music. KBM is available on video

    Also known as: Masaje al Bebé Canguro, Nursing intervention KBM

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What researchers measure

Primary outcomes

  1. weight

    Weight gain after randomization up to infant doesn´t need to stay in kangaroo position at home.

    Time frame: Through study completion, an average of 20 days

  2. Kangaroo position days at home

    Number days that the infant needs to stay in kangaroo position at home

    Time frame: Through study completion, an average of 20 days

Secondary outcomes

  1. Alert states

    The mother will observe and record YES OR NO the baby woke up during the intervention

    Time frame: Through study completion, an average of 20 days

  2. Types of feeding

    The mother will report whether or not the baby fed during the intervention and will identify the type of feeding (exclusive breast milk, formula or mixed)

    Time frame: Through study completion, an average of 20 days

  3. Perceived maternal parental self-efficacy

    The questionnaire contains 20 items with a Likert scale (1. Totally disagree, 2. disagree, 3. agree and 4. totally agree) the minimum value is 20 and the maximum is 80 and the higher scores means a better outcome.

    Time frame: Given by a self-report provided by the mother of the perceived maternal parental self-efficacy questionnaire on day 1 before randomization and day 7 and 14 after randomization

  4. Postnatal depression

    . This scale contains 10 points of 0, 1, 2 and 3 are given according to the increase in the severity of the symptom. The points for questions 3, 5, 6, 7, 8, 9, 10 are scored in reverse order (3, 2, 1, 0). All points are added together to give the total score. A score of 10+ means worse outcome and shows the probability of depression

    Time frame: Given by a self-report provided by the mother of the Edinburgh Postnatal Depression Scale on day 1 before randomization and day 7 and 14 after randomization

07

Study locations

1 site
  • Programa canguro ambulatorio
    Bogotá, 111321, Colombia
08

References and documents

Publications

  • Chan GJ, Labar AS, Wall S, Atun R. Kangaroo mother care: a systematic review of barriers and enablers. Bull World Health Organ. 2016 Feb 1;94(2):130-141J. doi: 10.2471/BLT.15.157818. Epub 2015 Dec 3. PubMed 26908962 ↗
  • Premji SS, Currie G, Reilly S, Dosani A, Oliver LM, Lodha AK, Young M. A qualitative study: Mothers of late preterm infants relate their experiences of community-based care. PLoS One. 2017 Mar 23;12(3):e0174419. doi: 10.1371/journal.pone.0174419. eCollection 2017. PubMed 28334033 ↗
  • Rangey PS, Sheth M. Comparative Effect of Massage Therapy versus Kangaroo Mother Care on Body Weight and Length of Hospital Stay in Low Birth Weight Preterm Infants. Int J Pediatr. 2014;2014:434060. doi: 10.1155/2014/434060. Epub 2014 May 25. PubMed 24976830 ↗
  • Holditch-Davis D, White-Traut R, Levy J, Williams KL, Ryan D, Vonderheid S. Maternal satisfaction with administering infant interventions in the neonatal intensive care unit. J Obstet Gynecol Neonatal Nurs. 2013 Nov-Dec;42(6):641-54. doi: 10.1111/1552-6909.12255. PubMed 25803213 ↗
  • Pados BF, McGlothen-Bell K. Benefits of Infant Massage for Infants and Parents in the NICU. Nurs Womens Health. 2019 Jun;23(3):265-271. doi: 10.1016/j.nwh.2019.03.004. Epub 2019 May 3. PubMed 31059673 ↗
  • Vargas-Porras C, Roa-Diaz ZM, Barnes C, Adamson-Macedo EN, Ferre-Grau C, De Molina-Fernandez MI. Psychometric Properties of the Spanish Version of the Perceived Maternal Parenting Self-efficacy (PMP S-E) Tool for Primiparous Women. Matern Child Health J. 2020 May;24(5):537-545. doi: 10.1007/s10995-019-02860-y. PubMed 31916144 ↗
  • Stuebe A. Should Infants Be Separated from Mothers with COVID-19? First, Do No Harm. Breastfeed Med. 2020 May;15(5):351-352. doi: 10.1089/bfm.2020.29153.ams. Epub 2020 Apr 9. No abstract available. PubMed 32271625 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04908332
Lead sponsor
Universidad Nacional de Colombia
Responsible party
Nubia Castiblanco Lopez (student Nursing PhD, Universidad Nacional de Colombia) — Principal investigator
First posted
Jun 1, 2021
Start date
Jul 22, 2021
Primary completion
Dec 16, 2021
Completion
Dec 16, 2021
Last update
Mar 4, 2022

Study contacts

Lucy Vesga Gualdron, Professor
study director · Universidad Nacional de Colombia
Fred Manrique Abril, Professor
study director · Universidad Nacional de Colombia
Nubia Castiblanco Lopez, PhD student
principal investigator · Universidad Nacional de Colombia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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