Clinical trial NCT04908332: Effect of Kangaroo Baby Massage on Mother-infant Interaction at Home
Official title: Effect of a Nursing Intervention on the Mother-baby Kangaroo Interaction at Home in Bogotá
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: weight
timeFrame: Through study completion, an average of 20 days
measure: Kangaroo position days at home
timeFrame: Through study completion, an average of 20 days
Secondary outcomes:
measure: Alert states
timeFrame: Through study completion, an average of 20 days
measure: Types of feeding
timeFrame: Through study completion, an average of 20 days
measure: Perceived maternal parental self-efficacy
timeFrame: 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
measure: Postnatal depression
timeFrame: 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
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Programa canguro ambulatorio
Study officials:
affiliation: Universidad Nacional de Colombia
name: Lucy Vesga Gualdron, Professor
role: STUDY_DIRECTOR
affiliation: Universidad Nacional de Colombia
name: Fred Manrique Abril, Professor
role: STUDY_DIRECTOR
affiliation: Universidad Nacional de Colombia
name: Nubia Castiblanco Lopez, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
citation: 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.
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. No abstract available.