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

Primary Purpose

Premature, Low Birth Weight, Mother-Infant Interaction

Status

Completed

Phase

Not Applicable

Locations

Colombia

Study Type

Interventional

Intervention

Kangaroo Baby Massage

About this trial

This is an interventional treatment trial for Premature focused on measuring Massage, Kangaroo mother care, low birth weight infant, premature infant, Mother- infant interaction, domiciliary, Nursing, home health nursing, telenursing

Eligibility Criteria

2 Days - 3 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Programa canguro ambulatorio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kangaroo baby Massage

Kangaroo position

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

weight

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

Kangaroo position days at home

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

Secondary Outcome Measures

Alert states

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

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)

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.

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

Full Information

NCT ID

NCT04908332

First Posted

May 18, 2021

Last Updated

March 3, 2022

Sponsor

Universidad Nacional de Colombia

1. Study Identification

Unique Protocol Identification Number

NCT04908332

Brief Title

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

Acronym

KBM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

July 22, 2021 (Actual)

Primary Completion Date

December 16, 2021 (Actual)

Study Completion Date

December 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Nacional de Colombia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Kangaroo baby Massage

Arm Type

Experimental

Arm Description

Arm Title

Kangaroo position

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Kangaroo Baby Massage

Other Intervention Name(s)

Masaje al Bebé Canguro, Nursing intervention KBM

Intervention Description

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

Primary Outcome Measure Information:

Title

weight

Description

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

Title

Kangaroo position days at home

Description

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

Time Frame

Through study completion, an average of 20 days

Secondary Outcome Measure Information:

Title

Alert states

Description

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

Title

Types of feeding

Description

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

Title

Perceived maternal parental self-efficacy

Description

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

Title

Postnatal depression

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Days

Maximum Age & Unit of Time

3 Months

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lucy Vesga Gualdron, Professor

Organizational Affiliation

Universidad Nacional de Colombia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Fred Manrique Abril, Professor

Organizational Affiliation

Universidad Nacional de Colombia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Nubia Castiblanco Lopez, PhD student

Organizational Affiliation

Universidad Nacional de Colombia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Programa canguro ambulatorio

City

Bogotá

ZIP/Postal Code

111321

Country

Colombia

12. IPD Sharing Statement

Citations:

PubMed Identifier

26908962

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.

Results Reference

background

PubMed Identifier

28334033

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.

Results Reference

background

PubMed Identifier

24976830

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.

Results Reference

background

PubMed Identifier

25803213

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.

Results Reference

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PubMed Identifier

31059673

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.

Results Reference

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PubMed Identifier

31916144

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.

Results Reference

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PubMed Identifier

32271625

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.

Results Reference

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

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