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

Breastfeeding Clinical Trial

— KBM  

Official title:

Effect of a Nursing Intervention on the Mother-baby Kangaroo Interaction at Home in Bogotá

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908332
• Other study ID #: UNColombia KBM
• Status: Completed
• Phase: N/A
• Start date: July 22, 2021
• Est. completion date: December 16, 2021

Study information

• Verified date: May 2021
• Source: Universidad Nacional de Colombia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 16, 2021
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

• 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.

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Breastfeeding
• Depression, Postpartum
• Feeding, Breast
• Low Birth Weight
• Mother-Infant Interaction
• Premature
• Weight Gain

Intervention

Behavioral:
• Kangaroo 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

Locations

Country	Name	City	State
Colombia	Programa canguro ambulatorio	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Vargas-Porras C, Roa-Díaz ZM, Barnes C, Adamson-Macedo EN, Ferré-Grau C, De Molina-Fernández 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight	Weight gain after randomization up to infant doesn´t need to stay in kangaroo position at home.	Through study completion, an average of 20 days
Primary	Kangaroo position days at home	Number days that the infant needs to stay in kangaroo position at home	Through study completion, an average of 20 days
Secondary	Alert states	The mother will observe and record YES OR NO the baby woke up during the intervention	Through study completion, an average of 20 days
Secondary	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)	Through study completion, an average of 20 days
Secondary	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.	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
Secondary	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	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