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

Study Overview
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Brief Summary
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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
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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

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

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

Intervention / Treatment
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* Behavioral: Kangaroo Baby Massage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kangaroo baby Massage<br>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<br>* 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<br>* Other names: Nursing intervention KBM;|
| Active Comparator: Kangaroo position<br>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<br>* 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<br>* Other names: Nursing intervention KBM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage, Kangaroo mother care, low birth weight infant, premature infant, Mother- infant interaction, domiciliary, Nursing, home health nursing, telenursing