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Completed

NCT Number: NCT04908332

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

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

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Key information

Conditions

Premature Behavior Body Weight Body Weight Changes Breast Feeding Breastfeeding Depression, Post-Partum Depression, Postpartum Depressive Disorder Feeding Behavior Feeding, Breast Female Urogenital Diseases and Pregnancy Complications Gain, Weight Low Birth Weight Mental Disorders Mood Disorders Mother-Infant Interaction Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Puerperal Disorders Signs and Symptoms Urogenital Diseases Weight Gain

Age range

2 day–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Programa canguro ambulatorio

Bogotá, 111321, Colombia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Masaje al Bebé Canguro, Nursing intervention KBM

Primary outcomes

  1. weight

    Time frame: Through study completion, an average of 20 days

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

  2. Kangaroo position days at home

    Time frame: Through study completion, an average of 20 days

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

Secondary outcomes

  1. Alert states

    Time frame: Through study completion, an average of 20 days

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

  2. Types of feeding

    Time frame: Through study completion, an average of 20 days

    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)

  3. Perceived maternal parental self-efficacy

    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

    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.

  4. Postnatal depression

    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

    . 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

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Colombia

Other

Registry information

Official study title

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

Acronym: KBM

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2021
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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