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

NCT04908332 | Completed DMC

• 1 other identifier: UNColombia KBM
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Alert states

  Through study completion, an average of 20 days

• Types of feeding

  Through study completion, an average of 20 days

• Perceived maternal parental self-efficacy

  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

• Postnatal 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

Study Arms (2)

Kangaroo baby Massage

EXPERIMENTAL

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

Kangaroo position

ACTIVE COMPARATOR

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

Kangaroo Baby Massage BEHAVIORAL

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

Kangaroo baby Massage; Kangaroo position

Eligibility Criteria

• Age: 2 Days - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Programa canguro ambulatorio

Bogotá, 111321, Colombia

Location

Related 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.

  PMID: 26908962 BACKGROUND

• 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.

  PMID: 28334033 BACKGROUND

• 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.

  PMID: 24976830 BACKGROUND

• 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.

  PMID: 25803213 BACKGROUND

• 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.

  PMID: 31059673 BACKGROUND

• 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.

  PMID: 31916144 BACKGROUND

• 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.

  PMID: 32271625 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Weight Gain; Depression, Postpartum; Breast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Puerperal Disorders; Depressive Disorder; Mood Disorders; Mental Disorders; Feeding Behavior; Behavior

Study Officials

• Lucy Vesga Gualdron, Professor

  Universidad Nacional de Colombia

  STUDY DIRECTOR

• Fred Manrique Abril, Professor

  Universidad Nacional de Colombia

  STUDY DIRECTOR

• Nubia Castiblanco Lopez, PhD student

  Universidad Nacional de Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The infant-mother dyads will not be Know that there are two different interventions in each group. This leads to greater adherence to treatment. The researchers: there will be two research assistants who will receive capacity regardless of the group of participants they are going to train, the main researcher will not carry out the training to the mothers and will be blinded. The nursing assistant in charge of weighing the baby and the pediatrician who determines the time of the kangaroo position. They will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: student Nursing PhD

Model Details: Two interventions groups of 34 each, participated in the study. The first group received Nursing intervention Kangaroo Baby Massage KBM at home and the second group received Kangaroo position KP at home, the KBM will start when the infant arrives at home until they leave the kangaroo position. The KP will measure since the baby arrive at home until leave the kangaroo position.

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 1, 2021
• Study Start: July 22, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: March 4, 2022

Record last verified: 2021-05

Locations

CO (1)